OncoMatch/Clinical Trials/NCT06236724
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Is NCT06236724 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Asciminib for chronic myeloid leukemia.
Treatment: Asciminib — To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Disease stage
Required: Stage EARLY CHRONIC PHASE
Excluded: Stage LATE CHRONIC PHASE, ACCELERATED PHASE, BLAST PHASE
early chronic phase (i.e., time from diagnosis ≤12 months); late chronic phase (i.e., time from diagnosis to therapy >12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: tyrosine kinase inhibitor
Exception: FDA approved TKI for <30 days is allowed
Participants who have received more than 30 days of prior FDA approved TKI
Cannot have received: antimetabolite (cytarabine)
Exception: 1 to 2 doses allowed
Participants who have received more than 2 doses of cytarabine
Cannot have received: chemotherapy
Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Cannot have received: radiation therapy
Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Lab requirements
Kidney function
creatinine clearance ≥30mL/min calculated using modified Cockcroft-Gault
Liver function
total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), SGPT or SGOT ≤3x ULN
Cardiac function
NYHA class 2B or better
Participants must have adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), SGPT or SGOT ≤3x ULN, creatinine clearance ≥30mL/min calculated using modified Cockcroft-Gault. ... To be eligible for this trial, participants should be [NYHA] class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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