OncoMatch/Clinical Trials/NCT05143840
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
Is NCT05143840 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Single Agent Asciminib and Low TKI for chronic myeloid leukemia, chronic phase.
Treatment: Single Agent Asciminib · Low TKI — This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Acute Myeloid Leukemia
Biomarker criteria
Required: BCR b3a2 (e14a2)
have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein
Required: BCR b2a2 (e13a2)
have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein
Disease stage
Required: Stage CHRONIC PHASE
Excluded: Stage ACCELERATED PHASE, BLAST PHASE
chronic phase; Patients with accelerated or blast phase CML (refer to appendix 4) [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor — CML
Minimal prior CML therapy with a TKI for less than or equal to 30 days
Cannot have received: BCR-ABL inhibitor (asciminib)
Subjects who have previously received treatment with asciminib
Cannot have received: allogeneic stem cell transplant
Patient has undergone a prior allogeneic stem cell transplant
Lab requirements
Blood counts
PLT count ≥ 50,000/mm3; ANC ≥ 500/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
eGFR ≥ 30 mL/min (CKD-EPI equation)
Liver function
AST and ALT < 3 x ULN; Total bilirubin < 1.5 x ULN or < 3.0 x ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)
Cardiac function
No history of MI, angina, CABG within 6 months; no significant arrhythmias; QTcF < 450 msec (male), < 460 msec (female) unless pacemaker; no long QT syndrome or risk factors for TdP; no concomitant meds with known risk of TdP unless discontinued/replaced 7 days prior; ability to determine QTcF interval
Adequate organ function: AST and ALT < 3 x ULN; eGFR ≥ 30 mL/min; Total bilirubin < 1.5 x ULN or < 3.0 x ULN with Gilbert Syndrome; PLT count ≥ 50,000/mm3; ANC ≥ 500/mm3; Hemoglobin ≥ 8 g/dL; Lipase ≤ 1.5 x ULN; Creatine phosphokinase < 2.5 x ULN; Cardiac or cardiac repolarization abnormality [see details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Winship Cancer Institute Emory University · Atlanta, Georgia
- Georgia Cancer Center at Augusta University · Augusta, Georgia
- Karmanos Cancer Institute · Detroit, Michigan
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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