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PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

Study acronym: PEARL
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 1 to 11
    • Start date changed from estimate of Jun 2025 to Jun 26, 2025
    v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  3. Collaborator revisedv4
  4. Primary completion date: Sep 2028 to Jun 2029
    • Start date: Sep 2024 to Jun 2025
    • Study completion date: Sep 2031 to Jun 2032
    v3
  5. Primary endpoint revisedv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B). All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued. During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily. The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.
Trial Details
NCT Number NCT06409936
Lead Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators: Grupo Español de Leucemia Mieloide Crónica
Conditions
(from sponsor)		 CML, Chronic Phase, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia, BCR/ABL-Positive, Chronic Myeloid Leukemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov