Medical Oncologist
Treatment-Free Remission in CML
Can You Ever Stop — Imatinib?
Stopping imatinib is a realistic goal for some people with CML — but it depends on how deep and how sustained your molecular response has been, and it requires close monitoring afterwards.
Medically reviewed by Dr. Bharati Devi Gorantla, Medical Oncologist, MBBS · MD · DM (Adyar, Chennai) · ECMO · MRCP SCE (UK) · Last reviewed August 2026
- A defined goal, not luck — Treatment-free remission is a recognised endpoint in CML care, not an informal experiment.
- Response depth decides it — The deeper and longer your molecular response, the better the chance of staying off treatment.
- Monitoring continues — Stopping imatinib is not the end of testing. BCR-ABL levels are checked frequently for at least a year.
- Restarting works — Most people who need to restart imatinib after a molecular relapse regain their response.
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Stopping imatinib is possible for a proportion of people with CML who achieve and sustain a deep molecular response for a defined period. Most guidelines require at least two years of sustained MR4 or deeper before an attempt is considered. Close monitoring continues after stopping, and most people who need to restart respond well.
Who is eligible to try stopping imatinib?
Treatment-free remission is not available to everyone on imatinib. NCCN and ESMO guidance identifies a specific profile: several years on imatinib, a sustained deep molecular response, and no history of accelerated or blast-phase disease.
The depth of your molecular response is measured by PCR testing. Guidelines generally require MR4 or MR4.5 — sustained over at least two years — before stopping is considered.
Your oncologist will also look at how long you have been on imatinib overall. A short treatment history, even with a good response, is generally not sufficient.
What your team typically checks before agreeing to stop
- You have been on imatinib for several years, not months
- Your BCR-ABL level has reached MR4 or MR4.5 on PCR testing
- That deep response has been sustained for at least two consecutive years
- You have not had accelerated-phase or blast-phase CML at any point
- You are able to attend regular PCR monitoring appointments after stopping
- You understand what to watch for and when to call your team
What does monitoring look like after you stop?
Stopping imatinib is the beginning of a monitoring phase, not the end of your relationship with your oncology team. PCR testing continues — usually monthly for the first year, then less frequently if BCR-ABL stays undetectable.
Most molecular relapses happen within the first six to twelve months. This is why the early monitoring schedule is intensive.
If BCR-ABL rises above the level your team is watching, imatinib is restarted. Data from the EURO-SKI trial and ESMO guidance report that the large majority of patients who restart regain the response they had before.
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Dr. C. Raghavendra Reddy
MBBS(Gold Medal), DNB(General Medicine), DM(Medical Oncology)(Gold Medal)
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Dr. Bharati Devi Gorantla
MBBS, MD(General Medicine), DM(Medical Oncology)(Adyar,Chennai), ECMO, MRCP SCE(UK)
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Dr. Owais Mohammed
MBBS, MD (General Medicine), DrNB (Medical Oncology), ECMO, MRCP SCE (Medical Oncology) (UK)
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MBBS (AIIMS), MS (Surgery) (AIIMS), DNB (Surgical Oncology), MRCS (Edinburgh)
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Dr. Vinay Mamidala
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Terms your team may use
- TFR (Treatment-Free Remission)
- Staying in remission without taking imatinib. It is an aim that requires eligibility criteria to be met first, not something that happens spontaneously.
- Deep molecular response (DMR)
- A level of BCR-ABL so low that standard PCR tests cannot detect it, or can barely detect it. It is the entry requirement for a TFR attempt.
- MR4 / MR4.5
- Specific levels of molecular response on the International Scale. They indicate that BCR-ABL is at very low or barely detectable levels. Both represent the depth of response that guidelines require before a TFR attempt is considered.
- BCR-ABL
- The abnormal gene fusion that drives CML. PCR tests measure how much BCR-ABL transcript is in your blood. The goal of imatinib is to reduce this to very low or undetectable levels.
- Molecular relapse
- A confirmed rise in BCR-ABL above the threshold your team is watching after you stop treatment. It means restarting imatinib, not that treatment has failed.
- PCR (polymerase chain reaction)
- The blood test that detects and measures BCR-ABL with very high sensitivity. This is the test that determines whether a TFR attempt is safe to start and whether remission is holding once you stop.
Questions people ask before attempting TFR
What happens if BCR-ABL starts rising after I stop?
Your team restarts imatinib. Most people who restart after a molecular relapse regain a deep molecular response within months. Data from the EURO-SKI study and ESMO guidance confirm that restarting is highly effective — this is the main reason TFR attempts are considered safe when done under proper monitoring. The key is attending every scheduled PCR test so that any rise is caught early, before it becomes symptomatic.
Does stopping imatinib mean the CML is gone?
Treatment-free remission means the disease is not detectable at the molecular level while you are off treatment. It is not the same as the disease being permanently eliminated from your body. Some patients stay in TFR for many years; others need to restart. We do not yet know with certainty which patients will sustain TFR long-term, which is why monitoring continues indefinitely rather than stopping after the first clear result.
How long does it take to know if TFR is working?
Most relapses occur within the first six to twelve months. If your BCR-ABL stays undetectable or very low through the first year of close monitoring, the probability of sustained TFR increases. Monitoring becomes less frequent after that first year if results stay stable, though it does not stop entirely. Your team will use your actual PCR results to guide how often you need testing as time goes on.
Can I attempt TFR more than once?
A second TFR attempt is possible for some patients who restart imatinib after a relapse, regain a deep molecular response, and meet the eligibility criteria again. The evidence base for second attempts is smaller than for first attempts, so the decision requires a careful conversation with your oncologist about your specific history and what the evidence supports at that point. Not everyone who restarts will be eligible to try again.
Will my oncologist suggest this, or do I have to ask?
Both happen. Some oncologists raise TFR proactively when a patient's PCR results meet the criteria; others wait for the patient to ask. If you have been on imatinib for several years and your BCR-ABL has been undetectable or very low for a sustained period, it is reasonable to ask your oncologist directly whether your results meet the criteria for a TFR discussion. Bring your most recent PCR reports to that appointment.
Did you know?
The possibility of stopping imatinib has been studied in large prospective trials. Data from studies including EURO-SKI, reported through ESMO, show that a meaningful proportion of eligible patients maintain deep molecular response after stopping — and that most who relapse regain their response after restarting.
The monitoring schedule is the safety net that makes TFR attempts feasible.
Source: ESMO Clinical Practice Guidelines for CML; EURO-SKI trial investigators
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Common questions
Frequently asked questions
Can everyone on imatinib eventually stop taking it?
No. TFR is available to a specific subset of patients who meet eligibility criteria around response depth and duration. Patients who have not reached MR4 or MR4.5, or who have not sustained it for a sufficient period, are not candidates at that point. Continuing imatinib safely and tolerably is itself a good outcome, and most people on long-term imatinib do well on it. TFR is an additional option for those whose disease has responded to the depth required, not a universal expectation.
How long do I need to be on imatinib before stopping is possible?
Duration alone is not the deciding factor — it is the duration of your deep molecular response that matters most. NCCN and ESMO guidelines generally require at least two years of sustained MR4 or MR4.5 before a TFR attempt is considered. Many patients who reach that threshold have been on imatinib for five years or more overall. Your oncologist will look at your full PCR history, not just the most recent result, to make this assessment.
Is TFR the same as stopping because the CML is gone?
No. Treatment-free remission means BCR-ABL is undetectable or very low and the disease is not progressing while you are off treatment. The distinction matters because it explains why monitoring continues: the aim is to catch any molecular relapse early enough to restart treatment before symptoms appear. We do not yet have reliable ways to predict which patients will remain in sustained TFR, so ongoing surveillance is the standard approach.
What side effects might I feel when I stop imatinib?
Some patients report musculoskeletal symptoms — aches and pains in joints and muscles — in the weeks after stopping imatinib. This is sometimes called TKI withdrawal syndrome and it is not a sign of relapse. It typically settles over weeks to months. Tell your oncology team about any new symptoms after stopping so they can assess whether it is withdrawal-related or whether your BCR-ABL needs checking sooner than scheduled.
Can imatinib be stopped if I am planning a pregnancy?
Imatinib carries risks in pregnancy, and TFR is sometimes discussed in this context for patients who wish to conceive. However, this is a specialist decision that depends on your response depth, disease history, and planned timing. It requires close coordination between your haematologist and a high-risk obstetric team. Raise it directly with your oncologist rather than stopping imatinib on your own.
What should I bring to an appointment about TFR?
Bring your last two years of PCR results if you have them, or ask your team to pull them before the appointment. A record of when you started imatinib and whether your dose has ever changed also helps. Write your questions down beforehand — the TFR conversation involves a lot of information and is easy to lose track of in clinic. Asking whether your current results meet the eligibility threshold is the right opening question.