OncoMatch/Clinical Trials/NCT06409936
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
Is NCT06409936 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Asciminib and Nilotinib for cml, chronic phase.
Treatment: Asciminib · Nilotinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR fusion with ABL1
Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML
Required: ABL1 fusion with BCR
Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML
Required: BCR e13a2 (b2a2) or e14a2 (b3a2) RNA transcript
Evidence at the time of study entry of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 (b2a2 or b3a2), which are required for BCR::ABL1 international scale reporting
Disease stage
Required: Stage CHRONIC PHASE, EARLY CHRONIC PHASE (WHO)
Excluded: Stage BLAST PHASE, SECOND CHRONIC PHASE AFTER PREVIOUS BP
Early chronic phase, less than 3 months from diagnosis; CML in blast phase (BP) or in second chronic phase after previous BP, according to WHO criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: tyrosine kinase inhibitor
Exception: prior treatment with any TKI for 30 days or less is allowed
Previous treatment with TKIs for more than 30 days
Lab requirements
Kidney function
Creatinine clearance > 50 ml/min using Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN; AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related
Adequate end organ function as defined by Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3.0 x ULN Alanine transaminase (ALT) ≤ 3.0 x ULN Serum amylase ≤ ULN Serum lipase ≤ ULN Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related Creatinine clearance > 50 ml/min using Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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