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 range18 Years – 65 Years
SexALL
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-…
What they're measuring
1
Impact of Ponatinib induction treatment on the TFR rate
Timeframe: 36 months after initiation of ponatinib