Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukem… (NCT04070443) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
France170 participantsStarted 2019-11-13
Plain-language summary
The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment.
The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients.
Who can participate
Age range
18 Years – 65 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:
* Male or female patients aged ≥18 and ≤65 years at time of inform consent signature.
* Cytologically confirmed CML, Philadelphia chromosome positive with or without additional chromosomal abnormalities and/or BCR-ABL positive (Major BCR (M-BCR) transcript exclusively), i. e. Cryptic Philadelphia chromosome patients can be enrolled:
* diagnosed within the past 3 months prior to D1 (i.e. within 60 days \[± 7 days\] since the date of first cytogenetic analysis),
* in chronic phase defined by i) \<15 % blasts in peripheral blood and bone marrow, ii) \< 30% blast plus promyelocytes in peripheral blood and bone marrow; iii) \< 20 % basophils in peripheral blood and iv) ≥100 X 109 platelets/L in peripheral blood,
* no extra-medullary disease.
* All EUTOS long-term survival Scores.
* No prior treatment for CML with any tyrosine kinase inhibitor (eg. imatinib, dasatinib, nilotinib or bosutinib), or busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; or any other investigational agent; with the exception of hydroxyurea and/or anagrelide which are the only authorized prior treatments.
Note: Hydroxyurea should be stopped at least 24 hours prior the initiation of ponatinib.
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2.
* Adequate organ functions as defined below according to lab tests performed within 7 days before Day 1:
Renal function:
\- Serum creatinine clearance ≥ 50 mL/min/1.73m2 according to CKD-…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Impact of Ponatinib induction treatment on the TFR rate
Timeframe: 36 months after initiation of ponatinib