Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia … (NCT01343173) | Clinical Trial Compass
CompletedNot Applicable
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
France220 participantsStarted 2011-04-06
Plain-language summary
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.
Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years and older.
* Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.
* Complete molecular remission under treatment with imatinib for at least 2 years.
* HIV serology negative and absence of chronic hepatitis B or C.
* Molecular monitoring according to the international recommendations before the beginning of the study
* For the women old enough to procreate, method of effective contraception
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion Criteria:
* Under 18 years old.
* Pregnant at the inclusion's time.
* Hospitalized patients without consent.
* Adults under law protection or without ability to assent.
* Previous or planned allogeneic stem cell transplantation.
* HIV serology positive or chronic hepatitis B or C.
* Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was looking at whether people with chronic myeloid leukaemia who stopped imatinib could stay in molecular remission long-term — does my current BCR-ABL transcript level suggest I might ever be a candidate for stopping imatinib, and what would need to be true before that conversation makes sense?
2The trial tracked 'molecular relapse' by monitoring for rising BCR-ABL transcripts after stopping treatment — if I were ever to stop imatinib, how frequently would my BCR-ABL levels need to be tested, and what would a significant rise actually mean for restarting treatment?
3Since this trial has already completed, has my care team seen or reviewed its findings, and do the results change how they think about long-term imatinib use for someone in my situation?
4This study is described as a 'persistence of remission' trial rather than a treatment trial — does that mean it was observing what happens naturally after stopping, rather than testing a new drug, and how does that affect how confident we can be about the safety of stopping imatinib based on this data?
5Are there patients for whom stopping imatinib is clearly not appropriate based on what trials like this one have shown, and is there anything about my current disease status or treatment history that would put me in that category?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript.