Titre officiel
A Phase 3, Randomized, Open-label, Multicentre Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Sommaire:
Le but de cette étude est de comparer l’efficacité
du ponatinib à celle de l’imatinib, tous deux administrés en première intention
en association avec une chimiothérapie à intensité réduite à des participants
atteints d’une leucémie lymphoblastique aiguë (LLA) à chromosome Philadelphie
(Ph+) récemment diagnostiquée, l’efficacité étant mesurée en fonction de l’obtention
d’une rémission complète (RC) sans maladie résiduelle minimale (MRM) à la fin
du traitement d’induction.
Description de l'essai
Primary Outcome:
- Number of Participants with Minimal Residual Disease (MRD)-Negative Complete Remission (CR)
Secondary Outcome:
- Event-free survival (EFS)
- Percentage of Participants with CR and Incomplete Complete Remission (CRi)
- Percentage of Participants with Molecular Response
- Percentage of Participants with Primary Induction Failure (PIF)
- Percentage of Participants with Overall Response Rate (ORR)
- Percentage of MRD-Negative CR
- Duration of MRD-Negative CR
- Duration of CR
- Time to Treatment Failure
- Duration of MR4.5
- Percentage of On-Study Participants with Overall Survival (OS)
- Percentage of On-Study Participants with Relapse From CR
- Overall Survival (OS)
The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat
people who have newly diagnosed Ph+ ALL. This study will look at the efficacy of ponatinib in
participants in addition to standard care.
The study will enroll approximately 230 participants. Participants will be randomized in a
2:1 ratio to receive oral ponatinib or imatinib (Cohort A and Cohort B, respectively) daily
throughout the study.
All participants will be asked to take ponatinib or imatinib at the same time each day with
reduced-intensity chemotherapy in induction phase (Cycles 1 to 3), consolidation phase
(Cycles 4 to 9) and maintenance phase (Cycles 10 to 20). At the end of the 20 cycles,
participants will remain on ponatinib or imatinib (administered as a single agent). The dose
of ponatinib in consolidation and maintenance phase will start with the last dose given in
the previous phase. The dose can be modified based on MRD-negative CR results.
This multi-centre trial will be conducted in Argentina, Australia, Austria, Belarus, Brazil,
Bulgaria, Canada, Chile, France, Mexico, Greece, Italy, Japan, Korea, Republic Of, Poland,
Romania, Russia, Spain, Taiwan, Province Of China, Turkey, Finland and the United States.
Participants including those who achieve a clinical response, may receive study drug until
they are deceased, have failed to achieve the primary endpoint, have experienced relapse from
CR or have progressive disease, have an unacceptable toxicity, have withdrawn consent, have
proceeded to HSCT, or until the sponsor terminates the study, whichever occurs first. After
disease progression, all participants will be contacted every 3 months for survival
follow-up. Participants will be followed until completion of the study or until the
participant's death has been reported.
Voir cet essai sur ClinicalTrials.gov
