Clinical Trial: A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+)

Brief Summary: The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)

Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Major Molecular Response (MMolR) [ Time Frame: 4 cycles (4 months) ]

defined as a breakpoint cluster region (BCR)-Abelson (ABL) ratio < 0.1% in the bone marrow sample of MRD4


Original Primary Outcome: Major Molecular Response (MMolR) [ Time Frame: 4 cycles (4 months) ]

defined as a BCR-ABL/ABL ratio < 0.1% in the bone marrow sample of MRD4


Current Secondary Outcome:

  • Complete remission after cycle 1 [ Time Frame: day 28 ]
  • Cumulative incidence of treatment- and transplantation-related mortality [ Time Frame: 2 years ]
  • Cumulative incidence of relapse [ Time Frame: 10 years ]
  • Relapse free survival [ Time Frame: 10 years ]
  • Event-free survival [ Time Frame: 10 years ]
  • overall survival [ Time Frame: 10 years ]
  • T315I mutation [ Time Frame: 10 years ]
    mutations will be assessed by Reverse transcription Quantitative Polymerase Chain Reaction (RQ-PCR) sequencing in case of progression or relapse
  • Toxicity [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Complete remission after cycle 1 [ Time Frame: day 28 ]
  • Cumulative incidence of treatment- and transplantation-related mortality [ Time Frame: 2 years ]
  • Cumulative incidence of relapse [ Time Frame: 10 years ]
  • Relapse free survival [ Time Frame: 10 years ]
  • Event-free survival [ Time Frame: 10 years ]
  • overall survival [ Time Frame: 10 years ]
  • T315I mutation [ Time Frame: 10 years ]
    mutations will be assessed by RQ-PCR sequencing in case of progression or relapse


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: November 19, 2015
Date Started: April 2016
Date Completion: December 2025
Last Updated: November 18, 2016
Last Verified: November 2016