Frequently Asked Questions

Bone Marrow Aspiration/Biopsy (BMA, BMB)

How often should a CML patient anticipate having a bone marrow aspiration or biopsy?

The Bone Marrow Aspiration/Biopsy (BMA/B) procedure may be done periodically throughout a person's treatment for Chronic Myelogenous Leukemia. The frequency can vary from physician to physician but most can anticipate the procedure at the time of diagnosis and perhaps yearly or more frequently until a deep response is achieved and maintained over time. Frequency may increase if incremental peripheral blood tests indicate a failure to achieve response milestones, particularly during the first 18 months of therapy. A new set of guidelines are currently under consideration that would call for a BMA/B at the time of diagnosis and another at three months. At the three month test, if response has been acceptable, or beyond, patients may be able to go long term without having to have the procedure as frequently. As stated above, frequency may increase if peripheral blood tests indicate a loss of response or failure to achieve and maintain response milestones. Patients participating in a clinical trial will find the trial protocol may stipulate a BMA/B schedule, which might be as frequent as every month.




What's the difference between a bone marrow aspiration and a bone marrow biopsy?

The bone marrow aspiration (BMA) removes a small amount of bone marrow fluid and cells through a needle placed into the bone, generally the pelvic bone. Less frequently, the sternum may also be used as a bone marrow aspiration site.

The bone marrow biopsy (BMB) removes a small amount of bone and is done at the same time as the aspiration.




Can there be complications from a bone marrow procedure?

Complications, although rare, but may include excessive bleeding at the collection site or infection. Patients should contact their doctor promptly if they experience persistent or spreading redness or bleeding at the site, fever, or persistent/increasing pain.

Patients should tell their doctor about any medications and/or supplements they are taking prior to the procedure.




Will I be put to sleep to have a bone marrow procedure?

This varies greatly, however it is usually not necessary. You may be given a sedative and a local anesthetic to ease any discomfort from the procedure. It is not out of the question to ask for the procedure to be done under sedation, however, this should be discussed with your doctor well in advance of the day of the appointment.





Caregiver

What are the functions of a caregiver?

The role of caregiver is one that can be as simple as accompanying a family member to an appointment to act as an extra set of eyes and ears, or as complicated as administering therapies and other aid. Caregivers are very important to the outcome of a serious illness or disease. For more information on the role of caregiver visit our Caregiver Support page.





Clinical Trials

What is a clinical trial?

A clinical trial is considered a biomedical or health-related research study. They may be referred to as a study, a trial or a protocol. There are two designations for these studies; interventional and observational.

Interventional studies are those in which the participants (research subjects) are assigned to a specific treatment or intervention by an investigator/doctor. Participants are carefully monitored and the outcomes are measured.

Observational studies are just that. Participants are observed and their outcomes are measured by an investigator.

The individual leading the clinical trial is called the Principal Investigator, and this person is usually a specialist in the area being studied. There will be several Associate Investigators who also take part in leading and organizing the clinical trial. In addition to the investigators, you may meet other members of the healthcare team including nurses, pharmacists and social workers.

Clinical trials are divided into three main phases, Phase I, Phase II, Phase III and Phase IV, according to the purpose of the trial. When new drugs are being investigated they must first be tested in a Phase I trial. A Phase I trial will determine the safety of the drug in humans and may determine maximum tolerated doses of the drug. Phase I studies are not done to determine a drug's effectiveness although observations may be made about participants' conditions if they are affected. Phase II studies are designed to use the information learned in the Phase I trials to plan interventions that may produce a desired effect in a participant. If there appears to be a significant benefit to the participants, a Phase III trial may be planned. Phase III trials expand these interventions to a larger number of people allowing the investigators to make assessments of efficacy, side effects, as well as its safety in a larger population. Phase IV trials are large studies of individuals taking a drug or using a new treatment after it has been approved and is on the market. These studies are important to the health of the public as new drugs and treatments are more widely used.

The most important aspect of a clinical trial is the Informed Consent. Informed Consent is both a process and a document. Informed Consent should be an ongoing communication between the investigators and the trial participants. As new information is learned or as changes are made, the participants should be informed. This communication should take place throughout the protocol.

The Informed Consent is also a document prepared to inform the participants about the clinical trial, what the trial's goals are, how long it lasts, any procedures, tests or treatments the participant may undergo and any risks or benefits to participation in the study. You should be provided your own copy of the Informed Consent Document. If the document is written in English and your native language is different, please ask for the document to be translated for you.

Informed Consent documents are signed and dated by both the Investigator and the Participant. Informed Consents ARE NOT CONTRACTS. The participant is not obligated to continue participating in the trial and may decide to stop participating at any time.




Why participate in a trial?

Being part of a clinical trial is just one way of taking a more active role in your own health and CML journey. Through a trial, not only can you gain access to therapies that might to be widely available or currently on the market. Additionally, you are contributing to medical research and allowing the investigators to gain greater insight in the treatment of your disease.




How do I get involved in a trial?

Each trial has certain guidelines that must be followed. Certain criteria is used to ensure that the research done will provide reliable results, thus participants must meet certain inclusion or exclusion criteria. These criteria may include factors such as age, gender, disease stage, previous treatment history, or other medical conditions. It is important to realize that these criteria are not used to include or exclude you PERSONALLY, they are used to identify appropriate candidates and to ensure the safety of those participating.




How does a trial work/what happens?

First off, you will be assigned a trial team, which may include your present doctor. Others involved are nurses, social workers, and other healthcare professionals. The team will evaluate your current state of health and give specific instructions on participation. Additonally, they will monitor you closely during the trial and stay in touch with you after the trial is completed.

Some trials involve more tests and doctor visits than you might normally experience when seeking treatment for CML. it is important that you understand that strict adherence to the trial protocol is not only important for the research team and study, it is important for your health and safety.




What is Informed Consent?


Prior to your agreeing to take part in a clinical trial, you will be informed of all details so that you can make the decision that is right for you. The information will give you key facts about the trial, including details of the study, its purpose and duration, required procedures, and key contacts. You will also be asked to sign an Informed Consent Document that outlines the potential risks and benefits of the study. Although you must sign this document to take part in the trial, the document is NOT a contract and you may withdraw from the study at any time.




What are some risks and benefits of participating?

As with anything in life, there are risks and benefits. Carefully considering these items are important to insure that you are fully informed about what will take place in the trial.

Benefits - clinical trials that are well-designed and executed are the best approach for participants to:

  • take an active role in their own health care.
  • gain access to new treatments before they are widely available to the general public.
  • obtain expert medica care at leading health care facilities
  • help others by contributing to medical research

Risks - although every precaution in take, there are risks associated with participating in a clinical trial.

  • possible serious or even life-threatening side-effects to experimental treatment
  • unpleasant procedures
  • the treatment may not be effective for you
  • the protocol may require more time and attention that non-protocol treatment, including more treatments, trips to a study site, hospital stays, or complex dosage requirements.




What questions should I ask when considering a clinical trial?

You should know as much as possible about any trial you are considering. Ask members of your care team questions about the trial, what type of care can you expect during the trial, and the costs involved. Here are some questions you might ask:

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective and has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trial be provided to me?
  • Who will be in charge of my care?




I've heard of a study that combines Gleevec and Interferon to achieve a cure. What is the theory and is it sound?

There are currently trials for combination therapy, the most popular being the Gleevec®/Interferon trial. Dr. Moshe Talpaz at the University of Michigan has been conducting this study, as well as other institutions.

There have been a small number of patients that were initially treated with Interferon and then later with Gleevec® that have been able to stop therapy for an extended amount of time. It is not yet fully understood what allows some to stop therapy without their CML returning, therefore it is unwise for any patient to arbitrarily stop therapy if they have had Interferon and Gleevec®. You should discuss ANY change of dosing/frequency with your treating physician.





Disease Progression

Can CML progress to AML (Acute Myelogenous Leukemia)?

For the most part, the simple answer is "no", CML does not progress to AML (there have been reported cases over the years of CML patients developing AML, however the occurrence is extremely rare). While blast crisis (BC) CML is similar to the acute leukemias, there are still differences. BC in CML can be delineated into two different types: myeloid blast crisis which closely resembles AML and lymphoid blast crisis which closely resembles ALL.

CML progresses through phases that are different from the acute leukemias. CML is differentiated into Chronic Phase, Accelerated Phase and Blast Phase.

Most patients are diagnosed with CML when in the chronic phase of the disease. If those in chronic phase go untreated, they may rapidly progress to the accelerated and blast phases of the disease. All efforts should be made to manage CML while in the chronic phase.

Each phase of CML can be described and differentiated by the number of immature cells found in the bone marrow. In Chronic phase, an individual's immature cells (called blasts) make up less than 10% of their bone marrow. In the Accelerated phase of CML, the amount of immature cells in the bone marrow comprise 10% to 30% of the total blood cells. In the Blast phase of CML, greater than 30% of the blood cells in the bone marrow are immature cells.

If a patient presents with a high number of immature cells in the bone marrow, the determination of what type of leukemia he or she has may not be readly available. At times, bone marrow material or blood from a past blood test can be used to identify the presence of the Philadelphia chromosome, or the BCR-ABL translocation. While very rare cases of some acute lymphoblastic leukemias can have the Phladelphia chromosome present, the vast majority do not. In these rare individuals, an oncologic pathologist will be able to see slight variations in the breakpoint region, that identify these as atypical Philadelphia chromosome findings and will warrant additional information to diagnose correctly.

Most pathologists will also look at the remaining normal cells in the patients blood and bone marrow. In CML you would likely see a large number of neutrophils and basophils. In patients with acute leukemias, the blood tests would show that the basophils are not as elevated and that the distribution of cell types would look more like a normal array. This knowledge assists in the determination of leukemia type. Blast crisis in a CML patient is extremely dangerous and all efforts should be made to avoid a patient's progression to this phase.





Drug Interactions

Can I use antacids to help with heartburn and other stomach issues?

Many people occasionally use an antacid or other over the counter medication for symptoms like heartburn, indigestion, gas or bloating. The majority of these medications can decrease the amount of a tyrosine kinase inhibitor (TKI) that your body can easily absorb.

ANTACIDS Antacids can reduce the amount of TKI (its bioavailability) that your body receives if taken too close in time to your TKI dose. The data from studies with dasatinib show that its absorption and solubility are affected by changes in pH. Antacids change the pH of the gastrointestinal environment. When dasatinib was given to 24 patients two hours after a dose of over-the-counter antacid (aluminum hydroxide), there was no relevant change in the dasatinib levels. However, when dasatinib was given at the same time as an over-the-counter antacid, the dasatinib level was significantly decreased. There have not been clinical trials with nilotinib evaluating the effects of antacid use. However, nilotinib is dependent on pH for solubility and would therefore, be effected by antacid use. Antacids may be used up to two hours before and two hours after a dose of dasatinib. Examples include Tums, Rolaids and Maalox.

PROTON PUMP INHIBITORS AND H2 ANTAGONISTS Medications in these categories also change the pH of the body's gastrointestinal environment, reducing the dose of TKI that your body is able to absorb. These drugs are particularly problematic because they tend to have much longer effects than the antacids discussed above. When 24 patients were administered dasatinib 10 hours after receiving famotidine, the patients dasatinib levels (bioavailability per AUC) were reduced by over 60%. When patients received bosutinib along with doses of lansoprazole, the bioavailability of bosutinb was decreased. Examples of these medications, which should not be used with TKIs, include: Pepcid, Zantac, Tagamet, Prilosec, Protonix, Nexium, and Prevacid.




Why does my CML specialist watch my thyroid function each visit?

Conditions involving the thyroid can be complex and difficult to diagnose, and much more so in individuals living with a cancer diagnosis. There is increasing evidence of changes in thyroid function related to treatment with tyrosine kinase inhibitors.

As more experience with tyrosine kinase inhibitors (TKIs) is documented through clinical trials and wider patient experience, there is increased focus on the effects of TKIs on the thyroid. With first generation TKIs used for cancers other than CML, there have been reports of changes in thyroid function in up to and over fifty percent of patients. There is significant experience with patients with renal cell carcinoma and with gastrointestinal stromal tumors. (See http://www.gistsupport.org/ask-the-professional/thyroid-damage-from-tyrosine-kinase-inhibitors/ and http://www.ncbi.nlm.nih.gov/pubmed/19333228)

More recently, investigators have been looking into the relationship of second generation TKIs, to thyroid dysfunction. In one German study, 45% of patients taking a second generation TKI experienced thyroid changes, including hypothyroidism and hyperthyroidism and other thyroid conditions. (Reference http://www.ncbi.nlm.nih.gov/pubmed/20929406)


In a study done by investigators at Harvard Medical School and published in 2011, the thyroid was affected by a number of the newer anti-cancer drugs, including the targeted therapies and TKIs needed by individuals living with CML.

The results of this study led to recommendations for routine thyroid testing in all patients taking targeted therapies including TKIs. It is important to note that although the most frequent thyroid related adverse effect is a decrease in thyroid function (hypothyroidism), other thyroid conditions can also be present and should be assessed frequently in the first year of therapy. Changes in function can happen as early as six weeks after beginning TKI therapy.

The treatment for hypothyroidism includes the oral administration of levothyroxine (Synthroid) on a daily basis. Patients appear to tolerate this well, although frequent laboratory testing may be necessary to regulate the dose of Synthroid in the period immediately following the initiation of therapy. Check with your CML team to find the results of your laboratory tests for thyroid function. Look for a pattern of increasing or decreasing levels of thyroid stimulating hormone (TSH). TSH will usually be elevated in cases of decreased thyroid function or hypothyroidism. Use a CML tracking system to record your laboratory results from this test and others related to your CML and overall health.





Fertility, Pregnancy, and Breast Feeding

Are there any fertility issues associated with CML therapy?

It has not been determined that CML therapy physically diminishes the ability to conceive, however, it is not wise to do so while in treatment. Conceiving while on Tyrosine Kinase Inhibitors (TKIs) can bring an increased risk to the pregnancy and ultimately the unborn child.

The following guidelines are common across all of the TKIs currently approved for therapy. The following lists those who should NOT be taking any of the Tyrosine Kinase Inhibitors used in the treatment of CML.

Women who are or could be pregnant should NOT be on therapy. Fetal harm can occur when administered to pregnant women; therefore, women should not become pregnant, as well as be advised of the potential risk to the unborn child if TKIs are used during pregnancy.

Women who are breast-feeding because of the potential for serious adverse reactions in nursing infants.

Sexually active females should use adequate birth control while taking therapy for CML.

Men in treatment for CML should also use adequate birth control and consult with their doctor prior to contemplating a family. It is generally thought that males should be clear of treatment for a minimum of eight (8) weeks prior to engaging in sexual activity with the intent to conceive. Some men have fathered children without a break in treatment and have seen no adverse effects on the child. It IS, however, always prudent to consult with your CML physician. This statement should not be construed as an endorsement by the NCMLS on conceiving while on treatment.

If you are pregnant, or think you may be, talk to your doctor and/or healthcare professional about these issues before beginning a CML treatment regimen.

Keep in mind that up to 50% of pregnancies are NOT planned. If you are taking therapy for CML and are sexually active, adequate birth control measures should be in force.




How soon after delivery can I resume my CML therapy?

As always, consult with your physician prior to beginning CML therapy. Generally, patients can resume therapy very soon following delivery - some the next day. You should not plan to breast feed while on therapy for CML.




Can I breast feed while taking therapy for CML?

Breast feeding should be avoided while on therapy due to the potential for adverse reactions in nursing infants. Consult with your physician should you have questions.





Food Interactions

Why should I not consume some fruits, particularly citrus?

Some citrus fruits, particularly Grapefruit, interact with Tyrosine Kinase Inhibitors by increasing the level of drug in your bloodstream. This increase in blood serum level can lead to an inadvertent overdose of your therapy drug. Consuming grapefruit, grapefruit juice, or grapefruit extract should be avoided while undergoing therapy for CML.

Starfruit and Pomegranate are also known to interact with TKIs and should be avoided.




I have lactose intolerance. Do the TKIs contain ingredients that could cause issues?

Nilotinib (Tasigna) contains Lactose (milk sugars) and should not be taken prior to discussing with your doctor.




Can I drink alcoholic beverages?

Alcoholic beverages are enjoyed responsibly by many people around the world. Alcohol when ingested, does require body systems and organs to be functioning well. Alcohol affects virtually every organ in the body including the linings of the gastrointestinal system, the functioning of the liver, the kidneys and more.

For individuals with CML, alcohol has generally been off limits. The effects of the disease along with certain toxicities associated with the treatment can be reasons to avoid all alcohol. When organs are processing medication and daily foods, the requirement to process alcohol may produce an unhealthy burden on your system. There are however, a number of individuals who have decided to continue with an occasional alcoholic beverage, and have appeared to tolerate it without evidence of a problem. The important thing to understand is the relationship between your body’s health while taking CML medications, and the effect alcohol would have on your health.

Most CML experts prefer that their patients avoid alcohol.





General Leukemia Questions

Is CML inherited?

Chronic Myeloid Leukemia is a genetic disease, but not a hereditary disease. The majority of CML patients have no family history of the disease and there is no evidence that it can be passed on to the children of someone living with the disease. Occasionally, there are families that may have other members living with leukemia, however, there is no conclusive evidence that family members are predisposed to develop leukemia.




Can leukemia be acquired through a blood transfusion?

Because there is no known cause of leukemia, the only way it could be acquired through a blood transfusion would be the the direct introduction of leukemic cells in the recipient. However, because the cells of a random donor would be seen as foreign, they would be immediately destroyed by the recipient. There is no evidence that leukemia has ever been acquired from a blood transfusion.




Are blood transfusions safe?

Yes. Today's screening processes exclude transmission of infectious agents. All donated blood (units) is screened for HIV, hepatitis B and hepatitis C.

There are a variety of other considerations such as noninfectious risks such as sudden destruction on the transfused red cells or even late destruction of the transfused red cell. However, these are very rare and the benefit outweighs the very small risk.

In some individuals with congestive heart failure, circulatory




What are the survival rates for CML?

The advent of tyrosine kinase inhibitors, has dramatically extended the expected life span of patients living with CML.

Life expectancy was once only 3-7 years after the diagnosis of CML was determined. Today we measure life expectancy in decades with most individuals living with CML anticipating a normal lifespan.

The National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database published findings about cancer and survival from 2005 - 2009 in the United States. From 2005 - 2009 CML patients lived to the median age of 75 years (72 years for men and 78 years for women). The World Bank reports that the average life expectancy across the US is 78.24 years in 2010. Individuals being treated for CML now experience closely comparable life expectancy rates to the general US population.

Quick Facts:

  • Approximately 1 in 599 people will be diagnosed with CML in their lifetime.
  • Approximately 4800 people are diagnosed each year in the United States with estimates ranging from 4500 to 5500.
  • There are an estimated 70,000 people living with CML in the United States (US) as of 2010.
  • That number will continue to grow until a plateau is reached near the year 2050, at which time we expect there to be about 181,000 people living with CML in the US.
  • There are differences based on gender, age and ethnicity, that will influence your risk of developing CML, as well as your overall expected survival with CML.

Based on the SEER Report, the incidence (how many people are diagnosed with CML in one year) of people developing CML is slightly lower than it was in 2001 and before. However, the prevalence (people currently living with CML) is much higher and this number will continue to grow until about the year 2050. The definitions of many of the statistics we read, may be confusing. Many people find that reading the primary definitions on the SEER website can be helpful in understanding what the statistics actually mean.

The journal CANCER published an article by Drs. Huang, Cortes and Kantarjian from MD Anderson Cancer Center in January 2012 (online), which focuses on the changes in the population of individuals living with CML in the United States and the changes expected in incidence, prevalence and survival statistics. An abstract of that article is available for your review and the information it outlines, provides a glimpse into the future of CML for the next generation.




What are the differences between AML and CML?

AML or Acute Myelogenous Leukemia is an acute form of leukemia that can develop quite rapidly. This form of leukemia is treated with chemotherapy and potentially a bone marrow/stem cell transplant should the disease not go into remission. Most AML patients quickly notice acute symptoms associated with the disease.

CML or Chronic Myelogenous Leukemia is a slow growing form of leukemia affecting the myeloid cells in the marrow. Many are diagnosed serendipitously while seeing their doctor for a regular physical or appointment. There have even been those diagnosed after their optometrist suggested they see their regular physician. Many have no symptoms at all and are completely unaware that they even had CML. Some may present with an enlarged spleen, fatigue, or other symptoms that might not be readily recognized as extreme.




Is my CML curable? Currently all of my lab tests are normal and are taken weekly. My Oncologist tells me I have to take this medication for life.

With CML, patients may required to take a therapy drug indefinitely in order to keep the disease from reappearing. It is thought that the leukemic stem cell (LSC) that initiates the disease perhaps goes into hiding when therapy drugs (Tyrosine Kinase Inhibitors - TKIs) are introduced into a patient's system. These "hiding" cells are referred to as Quiescent LSCs. In most cases, TKI therapy will keep the disease from progressing to an accelerated or blast phase, yet does not eliminate the LSCs.

For most patients, therapy is chronic and medications must be continued. It is critical that you take your medication as prescribed and do not miss doses unless advised to hold a dose by your hematologist/oncologist.

Currently studies are being conducted to explore the possibility that some patients may be able to stop treatment following an extended deep level response of greater than two years. These "Treatment Free Remission" (TFR) trials are continuing to provide great insights. One should not stop treatment outside the context of a clinical trial.

We are cautiously optimistic about finding a cure for CML. But a cure is not immediately available




I have had radiation therapy for a previous cancer. Do I have a higher risk for developing CML?

The occurrence of this is quite low but your health care team will ask you about previous radiation exposure when documenting your history. If they do not ask you, tell them so that they will have a complete picture of your medical history. There is some evidence that patients who have been diagnosed with other cancers and have received radiation therapy have a greater incidence of Chronic Myeloid Leukemia (CML). High levels of radiation exposure such as those experienced by individuals during World War II, have been associated with an increase in risk of developing several different types of cancers and conditions.




Does exposure to chemicals raise your risk of developing CML?

There are conflicting views on whether Benzene exposure increases a person's susceptibility to development of CML. There is a confirmed connection between Benzene exposure and Acute Myelogenous Leuemia (AML), however, research has been inconclusive on the connection between Benzene and CML.




Does having CML make me more likely to develop other types of cancer?

There has been no conclusive evidence that CML causes one to be more susceptible to develop other cancers. An important study undertaken at MD Anderson, which looked at secondary cancer development in patients with CML and myeloproliferative neoplasms being treated with Tyrosine Kinase Inhibitors (TKIs), concluded the following:

In conclusion, second cancers occur in a small percentage of patients receiving therapy with TKIs for hematologic malignancies, mostly CML. Analyzed in the context of the underlying lifetime risk of developing cancer by the general population and in patients who survive cancer, no evidence at the moment suggests that exposure to TKIs is carcinogenic. Continued long-term monitoring of these patients and reporting of any patients who develop second cancers are warranted to further define any possible longer-term risks.*

There are a number of epidemiological studies in progress that are analyzing both the incidence and prevalence of different cancers in families, geographic regions, cultures, occupations, etc. It will be interesting to learn of their results as they become available. Stay in touch with new research findings on the National CML Society's website and facebook page.

*Reference: Malignancies Occurring During Therapy with Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia. Blood. 2011 October 20; 118(16): 4353–4358. Prepublished online 2011 August 16. doi: 10.1182/blood-2011-06-362889

For a full text version of this article, see the US National Library of Medicine link HERE.

Article from Blood published here courtesy of The American Hematology Association.





Government, Legislative, and Regulatory Information


Immunizations

May an individual with CML receive the shingles vaccine? What about the chicken pox vaccine?

Using the most current infectious disease guidelines, Zostavax (shingles vaccine) may be given to CML patients who are stable and not experiencing any evidence of relapse or progression, and who do not have other immune suppressive issues such as recent requirements for high dose corticosteroids.

For Varivax (chicken pox vaccine), similar principles apply, though there is perhaps more of a need to consider administering Varivax if a patient has never had chicken pox, given the risks associated with a chicken pox infection.




May an individual with CML be around someone who has shingles, chicken pox, or has been vaccinated for either?

If a CML patient has never had prior chicken pox and has never had the chicken pox vaccine, then he or she should avoid contact with individuals with chicken pox or shingles. If the patient with CML had prior chicken pox or vaccination for chicken pox, then the concern is minimal as infection risk is dramatically lower.




Now that I have been diagnosed with CML, should I receive the flu shot or the flu mist nasal spray vaccine?


Given there is an injectable flu vaccine that poses NO risk for infection, then the shot is preferred over live attenuated (weakened) vaccines, which can cause illness or effects similar to the disease.





Men's Concerns

Are there any special considerations I should be aware of prior to fathering children?

Today, men in treatment for CML have much more flexibility than in the past when it comes to fathering children. Previously, it was thought that males should be clear of treatment for a minimum of eight (8) weeks prior to engaging in sexual activity with the intent to conceive. Now that we have longer term data, we are seeing that fathering children while taking a tyrosine kinase inhibitor has not posed discernable issues with the development of an unborn child. It is always wise to consult with your doctor prior to contemplating a family as each case is different, however being in treatment for CML does not seem to be a deterrent to having children for men. If you are contemplating starting a family, discuss these plans with your doctor. There are a number of men in our community who have fathered children while receiving treatment for CML and had perfectly healthy children.





Other/Miscellaneous

What is an Orphan Drug?

An "Orphan Drug" is a drug created for an obscure disease that affects such a small number of individuals residing in the United States that the disease or condition is considered rare. The Orphan Drug Act provides changes in applicable law to incentivize a pharmaceutical company to take on creating a drug that does not appear to have the potential to provide ROI (Return on Investment). The Act strives to ensure that potential drugs that might not otherwise be developed would be developed and made available to those that need them most.




My medications are delivered to my home while I am at work. They look almost melted when the mail order pharmacy delivers them. Is it safe to take them?

The question has become very important this season as record temperatures combined with a greater number of people relying on mail order and specialty pharmacies increases. There is not evidence that the temporary exposure to heat causes the medication to be ineffective or unsafe. But the questions of "how hot is too hot?" and "how long is too long?" have not been answered. Almost all clinical trials involving medications require that the medication be maintained, stored and shipped in temperature controlled environments. Some exceptions are made for brief excursions when being shipped, moved, stored or dispensed. And it is these stringent clinical trials that our current knowledge of medication storage and shipping practices and recommendations is based. There are pharmacists and clinical researchers at the major drug companies and mail order pharmacies who are attempting to answer the question now, but we don't have the necessary answers yet. What can you do? You should submit a request in writing to the company that ships your medication, for the drug(s) to be sent in a protective container with a freezer pack or cold pack. If any medication shows signs of melting, sweating, cracking, discoloration or other physical change to the outside of the pill or capsule, you should not take the medication. If you have any concerns that the effectiveness of the medication you have taken has been compromised, please share those concerns with your hematologist, oncologist or CML specialist. They will be able to arrange more frequent testing to confidently determine if your condition has changed in any way. Strategies you can use during warm weather months: 1. Have your medications delivered to your office or workplace, instead of to your empty front porch. 2. Request in writing that your mail order pharmacy pack the medication in a layered or insulated container or cooler, with the addition of a freezer pack or cold pack. 3. Request in writing that your mail order pharmacy send your shipment overnight to avoid long layovers in warmer climates. 4. If there is any delay in getting your medication on time, please contact your CML specialist, hematologist or oncologist so that they can help you make arrangements to obtain your drug on schedule. Skipping doses is NOT an option.




Can I have Pets?

You have leukemia, CML to be specific, and you also have wonderful pets that you would like to keep and protect. This is a great question and one faced by many individuals and families.

As you know, there are four primary types of leukemia: Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL). CML behaves somewhat differently than CLL, AML and ALL. CML compromises your immune system's ability to protect you. In untreated CML, leukemic cells gradually replace healthy, mature cells and the result is that you become vulnerable to many infections.

When treated with tyrosine kinase inhibitors and other effective treatments, the leukemic cells are reduced and hopefully eliminated, leaving the environment available for the production of healthy cells which mature and are fully functional. Depending on your condition and phase of disease when diagnosed, your immune system will be compromised to different degrees. Once treatment begins, your immune system will be restored over time and protective functions will resume. When you achieve a deep response to treatment and maintain it over time, your immune system will function essentially like any person without CML.

If your CML progresses to accelerated or blast phase, your immune system will once again be in trouble and will not be able to protect your body as fully as it should.

So the answer to the question, "Can I have pets if I have CML?" is, "It depends." If you are in treatment for CML with a tyrosine kinase inhibitor or other effective treatment, and you have achieved and maintained a good response to that treatment, there are no contraindications to you having pets. However, if you are newly diagnosed, are transitioning treatments due to disease progression, or considering stem cell transplant please talk with your CML specialist about your pets. He or she will be able to tell you if your immune system is healthy enough to safely care for an live with pets.

There are several websites which cover precautions for individuals with compromised immune systems. Please make sure that the source of your information is credible and reliable.

Tips to Keep You and Your Pet Safe and Healthy

General

  • Research your pet, its breed and special needs.
  • Keep all immunizations up to date and visit your veterinarian regularly.
  • Keep animals as clean as possible.
  • Consult your veterinarian should your pet experience coughing, sneezing, discharge from eyes, vomiting, diarrhea or weight loss.
  • Keep nails trimmed to avoid scratches to your skin.
  • Feed only commercially prepared pet food. This prevents your pet from contracting toxoplasmosis (cats) or other illnesses from eating undercooked food or wild animals.
  • Prevent your pet from drinking water from the toilet.
  • Use safe and effective flea and tick protection all year.
  • Avoid contact with outdoor areas where animal droppings, urine or feces may be.

Cats

Keep your cat's litter box in a separate area from your living and eating space. Use gloves and a mask when changing litter and then dispose of same. Scoop litter daily. Always wash your hands after handling litter box.

Make sure testing for feline leukemia and feline immunodeficiency has been done. Although you can't "catch" these viruses, which may compromise your pet's immune system making them vulnerable to illnesses that might be harmful to you.

Dogs

Keep nails trimmed to avoid scratches. Minimize boarding or kennel visits as dogs can share "kennel cough" with their family.

Birds

Wear gloves and a mask when cleaning cage or disturbing the contents of the cage. Take care when handling your bird to avoid being scratched.

Reptiles

Wear gloves when handling your reptiles and when cleaning their tanks and cages. People can be exposed to salmonella from reptiles representing a risk to patients.

Please remember to enjoy your pets too! They are faithful friends and members of our families. Having pets in your life can be an enjoyable and helpful therapy itself.




I have leftover medication because my doctor switched me to another drug. Can I give it to someone in need? What can I do?

This has been a challenge for our community for a long time. Currently, the NCMLS (and many other organizations) recommend that you take any unused CMLmedications (drugs such as Gleevec, Sprycel, Tasigna, Busulif, and Iclusig/Ponatinib) to your oncologist. Doing so provides the greatest opportunity for others to benefit from it if they cannot afford or have difficulty accessing their CML medication.

As you know, precription medications are "controlled substances" and therefore only intended for the person for whom they're precribed. Laws vary by state regarding possession of these medications, and while each State's law may be slightly different, they call for some strict penalties for those found to be abusing them by illegally distributing or transporting these drugs.

While we know that it happens and is probably done with the best of intentions, penalites can be quite severe. For example, according to the Drug Enforcement Agency of the United States charged and convicted violators can lose access to government programs such as Medicare and Medicaid. Depending upon the degree of violation, a lifetime ban can be imposed.

Use of the US Postal Service can increase any penalties as the violation then involves using a government service as a means of transport and distribution of a controlled substance if discovered. Shipping companies such as UPS or Fedex have strict rule on what can be shipped via their services. Please review their respective websites for specifs information on shipping policies.

When it comes to selling unused medications, one is subjected to even more risk as the violation moves from one of "wanting to help" and perhaps not knowing the regulations governing prescription drugs, to on of profiting from the sale of a substance that is regulated by a federal agency.

Giving your leftover CML medications to your oncologist not only eliminates the risks associated with distritribution of these drugs, it provides the greatest opportunity for the medication to be used to help someone who may otherwise not be able to afford or access treatment for their disease.

The National CML Society has contemplated ways in which to address this issue, including discussions with key CML physicians, pharaceutical companies, and regulatory agencies. Hopefully, one day we will have a viable, safe, and legal option for disposing of our unused CML medication.





Pediatric and Adolescent Concerns

What is Pediatric CML?

Pediatric CML is the condition of chronic myeloid leukemia occuring in infants and children. The term "children" is associated with a number of definitions. For our discussions, we refer to the pediatric patient as one between the ages of 0-14 years, and adolescent patients as those 15-19 years of age. A third category of underrepresented cancer patients are those who fall into the young adult category. These are individuals who are 20-39 years of age. Most of the information presented here will refer to pediatric and adolescent patients.

While there are cases of Pediatric CML found across the world, it is in fact an ultra rare disease and accounts for less than three percent of all pediatric leukemias. As a child ages, the incidence of CML increases with children one to fourteen experiencing the disease at a rate of 0.7 cases out of a million children, and teenagers experiencing the disease at a rate of 1.2 cases per million. While the community is grateful that CML in children and teenagers is considered ultra rare, its scarcity creates difficulty for scientists and hematologists who study and treat the disease, as well as families who need community support.

Today, children with CML and their families benefit from the technology that has allowed researchers and clinicians around the world to combine their efforts and join forces to understand more about CML in children. This digital alliance has allowed the exploration and creation of new treatment options, and the expansion of opportunities to find a cure. Look at the material we have included for you here and visit the resources and links provided. If you are interested in seeing a Pediatric CML specialist, visit our list for contact information.




Treatment Considerations for Pediatric CML

Tyrosine Kinase Inhibitors (TKIs) are the drugs most often used to treat CML today. The drug imatinib(Gleevec®) made by Novartis Pharmaceuticals, is a tyrosine kinase inhibitor and became the drug of choice for adult patients living with CML in the last decade. Imatinib completely changed the way CML was treated.

Prior to the year 2000, both pediatric and adult patients were treated with either traditional chemotherapy, interferon or bone marrow transplants. Most people lived only 3-5 years at that time. Today, both adult and pediatric patients have options that a patient 15 years ago, could not have dreamed possible and an expected life span near that of family and friends without CML.

Treatment of Pediatric CML patients remains largely based on experience with adult subjects in controlled clinical trials for CML. Many of the same monitoring guidelines and treatment guidelines will parallel those for the adult CML patient population. But it is vitally important that one does not treat a pediatric patient as if he or she were simply a small adult. Pediatric CML patients require a careful analysis of factors unique to their age and condition.

There are important differences in the considerations one makes for treating pediatric CML.

(1) Sokol Score - The Sokol score, in use for several decades as a way of assigning adult patients to a stratified risk group, is not as useful in children and adolescents.

(2) Potential Growth Delays - Consideration must be given to growth and development concerns, and the risks of TKIs to a child's physical maturation. A number of case studies include issues of decelerated growth in children on imatinib prior to puberty.

(3) Potential Long Term Effects - There is still much to be learned about the effect of long term use of TKIs on children. Anticipating a much greater lifespan than children with CML just ten years ago, pediatric patients today may be exposed to TKIs for many decades. Adult CML patients also face this unknown and the only way to answer the question of safety in long term treatment with TKIs, is time.

(4) Potential Cardiac Effects - Each of the TKIs has its own side effect profile, but they all have the potential to cause changes in the heart and lungs that may be serious. The collection of thorough baseline studies prior to starting treatment, and careful monitoring after starting treatment, will assist in the identification of young patients who may be at higher risk for problems such as prolonged QT intervals, pleural effusions, etc. There is insufficient data to make assessments which would allow us to predict the development of the more serious potential effects of TKI therapy. At this time there does not appear to be an increased risk in children, beyond that experienced by adults in the larger studies.

(5) Transplant Options - The decision to proceed with transplant is an important one for the patient and the family. There are significant amounts of experience with transplants and children available to consider. Transplants are much safer today than they were in years past, and children in particular, tend to do well compared to their adult counterparts. If your family is considering a Stem Cell Transplant, consider exploring information with Be The Match.




How do pediatric patients take their medicine?

Medication administration in pediatrics is an opportunity for parents and caregivers to practice creativity, patience and self-control. For anyone who has attempted to bribe, manipulate or coerce an unwilling child to take their oral medication, we salute you. Parents tell us that enticing a child to swallow unwanted medication is almost impossible. We understand that you may be facing this challenge not just one time, but many times, day after day.

While you may be facing a difficult time now, it does get easier, at least for a time. Once you believe you have medication administration conquered, your child grows into an adolescent and new challenges face you each day. But again, it will get easier. Adults experience similar cycles of waxing and waning motivation to take their medications on time, every time. Even well intended adults may wish to hide behind the sofa somedays and take a break from what feels like the daily grind of taking medicine.

It is important for parents and caregivers to understand the VITAL role they play in helping their child achieve and maintain a deep response to their CML medication. Not only do your actions assure that today's dose of TKI is taken on time, but the habits and routines are forming, that will encourage your child to continue proper medication usage for the remainder of his or her life. Parents and caregivers teach children that taking their TKI is something good to do for oneself, and a way of taking care of oneself.

But how can you make a pill or capsule palatable for a young child? With so many limitations on when and how you must take specific medications, taking a TKI on time, every time, can be quite challenging. We have some hints for you that have helped other parents facing similar challenges. The tips are listed below for you to consider.

Imatinib - Use a clear liquid such as water, apple juice or favorite pre-packaged, non-dairy drink to dissolve the imatinib tablet. In the journal BLOOD in February 2012, Dr. Andolina suggests a 2:1 dilution of 2 parts medication (measured in milligrams) to 1 part clear beverage (measured in millileters). If your child was prescribed 400 milligram tablets, dissolve one tablet into 200 millileters of liquid. Most measuring cups will have millileters clearly marked and it is important to actually measure the beverage instead of guessing. Cold beverages seem to work well for most children. If your child has a "sippy cup" or some type of closed-lid cup or glass, you can dissolve the tablet by shaking the container with the lid in place. Avoid milk and other dairy products. Avoid mixed fruit juices which may contain grapefruit or its extract. Check the inside of the glass after your child has taken the medication to assure there are not visible parts of medication clinging to the sides.

Dasatinib - Much less liquid is needed to dissolve Dasatinib. Tablets can be placed in 30 mls of lemonade or apple juice and allowed to sit on your kitchen cabinet for about twenty minutes until the tablet is fully dissolved. Check the inside of the cup for medication residue. If present, add a teaspoon or two of water, lemonade or juice and administer that to your child also to assure that he or she receives the correct full dosage. Fluids can be cold or room temperature but not hot.

Nilotinib - Dealing with the need to take Nilotinib on an empty stomach is one of the most challenging pieces of caring for pediatric CML patients. Remember that this medication does require that it is to be taken on an empty stomach. To best administer the medication, separate the capsule ends with gentle pressure. Spread the medication on a teaspoon, or 5 mls, of applesauce. Have your child take the medicine using small disposable medicine cups or measure one teaspoon of the applesauce and place it into a small disposable water cup. The smallest bathroom cups, purchased with a dispenser and the necessary images of a favorite cartoon character, or riddles or jokes, on the cup. It may seem trivial but these small changes may help you go from arguments at every mealtime, to a more peacable family life around "medicine time."





Response/Remission

Do we have remission with CML?

For anyone facing a cancer diagnosis, remission is a much sought after thing - a "safe haven." For those with Chronic Myelogenous Leukemia (CML), the word "remission" may often be replaced with the word "response" when discussing the disease with fellow survivors or medical teams** The reason being that remission is often times perceived in the general public, or perhaps thought of, as a state in which the disease has been eradicated or brought under complete control so that NO ADDITIONAL therapy/treatment (chemotherapy, biological therapy, radiation, surgery, etc.) is necessary. Some in the CML community have had family, friends and acquaintances become very concerned or alarmed to discover that they are STILL taking treatment. Questions such as "I thought you were in remission?" or "Has your cancer come back?" are asked frequently. With CML, patients are currently required to take a therapy drug indefinitely in order to keep the disease from reappearing. It is thought that the leukemic stem cell (LSC) that initiates the disease actually goes into hiding when therapy drugs (Tyrosine Kinase Inhibitors - TKIs) are introduced into a patient's system. These "hiding" cells are referred to as Quiescent LSCs. In most cases, TKI therapy will keep the disease from progressing to an accelerated or blast phase, yet does not eliminate the LSCs. There are three categories of response CML patients experience.

  1. Hematologic Response - blood counts return to the normal ranges.
  2. Cytogenetic Response - the disease has been greatly reduced, or no longer appears in the bone marrow.
  3. Molecular Response - the disease as been decreased to a point that it is no longer detectible in the marrow, or it is no longer detectible utilizing Polymerase Chain Reaction (PCR) testing.
NOTE: Being found "CMR", "undetectible" or "PCRU" does not indicate cure as there is no way to know whether every cell in your body is free of the Philadelphia Chromosome. ** More on remission vs response:
Merriam Webster defines remission as: "a state or period during which the symptoms of a disease are abated <cancer in remission AFTER treatment>." Another source* defines remission as "diminution or abatement of the symptoms of a disease; the period during which such diminution occurs." As you can see, CML DOES fit some definitions of remission, yet if you were to survey 100 people, you might find many different definitions. *Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. (c)2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved. Click here for more information on response




Do most people become resistant to Gleevec?

No, in fact, only a small percentage of individuals develop resistance to Gleevec® or other TKIs. You Hematologist/Oncologist will order the appropriate tests to determine if resistance has developed but only based on significant changes in your blood work.




What is a Log Reduction?

"Log reduction" is a mathematical term used to show the relative number of cells, germs, microbes, etc., reduced in or on something. When the term log reduction is used in CML, it refers to the reduction one's CML, or specifically BCR-ABL

.

For example, a "5-log reduction" means the number of Philadelphia Chromosome positive cells have been reduced 100,000-fold.

Log Reductions

1 log reduction means the number of CML cells is 10 times smaller

2 log reduction means the number of CML cells is 100 times smaller

3 log reduction means the number of CML cells is 1000 times smaller

4 log reduction means the number of CML cells is 10,000 times smaller

5 log reduction means the number of CML cells is 100,000 times smaller





Sexuality

What if my partner has Human Papillomavirus (HPV)? Am I at higher risk of getting HPV, genital warts or cervical cancer?

The Human Papillomavirus is the name for a group of viruses, with at least forty types that can be sexually transmitted. This type of HPV is called genital HPV and it is the most common sexually transmitted disease today. Genital HPV is very seldom symptomatic, so most people will not know that they have it unless they develop genital warts or cervical cancer from it. It is important to know that there is no cure for genital HPV at this time, and someone can contract more than one strain of the HPV. For that reason, prevention is a critical topic for men and women who are sexually active, to discuss and consider. Individuals with HPV may be contagious at any time and the presence of symptoms is not necessary to to present a risk of infection to others. This is particularly important for individuals living with CML or other illnesses that may interfere with normal immune functioning. In most cases, the patient in active treatment for CML with a tyrosine kinase inhibitor, is at risk for contracting HPV at the same degree as other healthy individuals in the population. If the CML patient’s lab work is normal, if his or her immune system is healthy and if he or she plans to continue treatment everyday, there should be no increased risk to him or her beyond that of the average population. But remember, HPV is the most common sexually transmitted disease, with approximately 20 million people in America ages 15 - 49 affected. Once you have been diagnosed with HPV, it is important to understand that there is no cure. HPV can cause genital warts, cervical cancer and anal cancer. Please be vigilant in seeking care for yourself on a regular basis. It is critical to your health. Until such time as a cure can be found, it is important to use condoms/barriers when having any form of sexual contact, to prevent exposure for yourself, and to prevent you or your partner from contracting a different strain of the HPV. For more information about the Human Papillomavirus and genital warts, consider the following link: https://www.womenshealth.gov/a-z-topics/human-papillomavirus





Side Effects

Many people talk about "chemo-brain" or the "Gleevec Fog". Is there an increased chance of Alzheimers or other neurological issues associated with taking this medication long term?

A link between taking Gleevec® and Alzheimer's disease has not been established. Additionally, there are no established links between the drug and other neurological issues.​




I have an arrhythmia but I worry at times if the skipping beats are normal or if it's indicating a problem my heart is experiencing with the drug. If there are tests we should be having, what are they and how often should we have them?

Tyrosine Kinase Inhibitors (TKIs) do have the propensity to affect the heart's rhythm, however it is not a primary side effect of these drugs. It is recommended that all patients with outstanding heart issues talk with their doctor prior to starting Gleevec® or any TKI for their CML. An EKG would be appropriate before beginning any of these medications and during treatment at appropriate intervals.




What are the side effects associated with taking Gleevec?

Many individuals receiving treatment for their CML will experience side effects from time to time. Some more than others. Most will see these side effect dissipate or go away completely over time. If you are experiencing side effects, do not hesitate to report them to your doctor, no matter how insignificant you may think them to be. By sharing with your doctor, you can work together to minimize them. Most side effects can be addressed without the need to stop your therapy.

Some common side effects of Gleevec® may include:

  • Fluid retention
  • Puffiness around the eyes (Periorbital Edema)
  • Nausea
  • Vomiting
  • Muscle Cramps
  • Diarrrhea
  • Rash
  • Mouth soreness

Gleevec® may also cause a loss of bone minerals. Your doctor can discuss this with you and test for this possible side effect.

You can find more information on Gleevec side effects here.




What are the side effects associated with taking Sprycel?

Many individuals receiving treatment for their CML will experience side effects from time to time. Some more than others. Most will see these side effect dissipate or go away completely over time. If you are experiencing side effects, do not hesitate to report them to your doctor, no matter how insignificant you may think them to be. By sharing with your doctor, you can work together to minimize them. Most side effects can be addressed without the need to stop your therapy.

Some common side effects of Sprycel® may include:

  • Fluid retention in the chest and other tissues.
  • Too few red cells, white cells, and/or platelets (myelosuppression)
  • Diarrhea
  • Nausea
  • Headache (Many individuals taking Sprycel® complain of a headache "in the mask", similar to sinus pressure headaches. These headaches tend to dissipate over the first couple of weeks of beginning therapy.)
  • Low calcium levels in the blood
  • Slight changes in liver function

You can find more information on Sprycel side effects here.





Stem Cell/Bone Marrow Transplant


Surgical Considerations


Testing/Monitoring


Women's Concerns


Treatment Free Remission - TFR


 

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