An Efficacy Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Participants With Newly Diagnosed Ph+ ALL

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
  • Percentage of Participants with MR4.5 Including Best Response
  • 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 230-320 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

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