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Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 22, 2024 (before its estimated November 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 22 of 22 sites
    v5
  2. Primary completion date: Nov 2022 to Nov 2024v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date changed from estimate of Feb 2021 to May 4, 2021
    v3
  4. Start date: Oct 2020 to Feb 2021
    • Primary completion date: Jul 2022 to Nov 2022
    • Study completion date: Jul 2024 to Nov 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II interventional trial to evaluate if the use of ponatinib, with or without chemotherapy, can induce a molecular remission in MRD-positive patients, in patients in hematologic and extra-hematologic relapse and in the few patients who never achieved an hematologic remission after whatever prior treatment.
Trial Details
NCT Number NCT04475731
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Philadelphia-Positive ALL, Acute Lymphoblastic Leukemia, in Relapse
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov