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Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2021 to Sep 8, 2021
    • Study sites: 0 to 15
    • Primary and study completion dates: Jun 2027 to Sep 2027
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients based on the combination of Ponatinib with Blinatumomab. The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients (\>65 years old). Patients will be randomized 2:1 to receive the experimental or control arm. If patients in the control arm do not achieve a CHR and/or MRD negativity, after the sixth consolidation cycle (week 20), a crossover to receive Blinatumomab is planned. Likewise, if patients in the control arm develop an ABL1 mutation at any time of treatment, they will switch to experimental arm. HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years. After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm, patients aged 18-65 will be stratified for transplant allocation.
Trial Details
NCT Number NCT04722848
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), ALL, Adult, Philadelphia-Positive ALL
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov