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

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.

NCT Number	NCT06409936
Lead Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto Collaborators: Grupo Español de Leucemia Mieloide Crónica
Conditions	CML, Chronic Phase, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia, BCR/ABL-Positive, Chronic Myeloid Leukemia
Enrollment	160 participants
Start Date	2025-06-26
Primary Completion	2029-06 (estimated)
Study Completion	2032-06 (estimated)
Updated on ClinicalTrials.gov	2025-07-08