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Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 1, 2025 to Mar 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 24 of 24 sites
    v5
  2. Study sites: 1 to 24v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2024 to Feb 1, 2025
    • Study completion date: May 1, 2028 to Jul 1, 2028
    • Start date changed from estimate of Sep 1, 2022 to Oct 5, 2022
  4. Primary completion date: Aug 1, 2022 to Dec 1, 2024
    • Start date: Jul 1, 2022 to Sep 1, 2022
    • Study completion date: Mar 1, 2028 to May 1, 2028
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Acute lymphoblastic leukemia (ALL) is the most frequent cancer in children, decreases in adolescence and adulthood, and a second peak can be recorded starting from the 6th decade of life. While the outcome in children is excellent, in the adolescent/adult population, the prognosis, though improved over the decades, it is still unsatisfactory and novel biologically-driven approaches are urgently needed. In this setting, thanks to the introduction of genome wide technologies, it was possible to recognize specific subset of ALL. Among those, the BCR/ABL1-like ALL are of extreme importance, since they are characterized by an unfavourable outcome and, on the other hand, can benefit of a targeted treatment, in particular with the pan-tyrosine kinase inhibitor ponatinib. The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.
Trial Details
NCT Number NCT05306301
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
(from sponsor)		 Chemotherapy, Leukemia, Acute Lymphoblastic
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov