OncoMatch/Clinical Trials/NCT04838041
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Is NCT04838041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for chronic phase chronic myelogenous leukemia.
Treatment: Asciminib 40 MG · Asciminib 40 MG Twice Daily · Asciminib 80 MG daily · Imatinib · Nilotinib · Dasatinib — This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic 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
Required: BCR MR4.5 (< 0.0032% IS)
Must have a RQ-PCR for BCR::ABL1 < 0.0032% IS (MR4.5) reported by the trial designated central lab at the time of study enrollment
Excluded: ABL1 T315I
without BCR::ABL1 ^T315I
Disease stage
Required: Stage CHRONIC PHASE
Excluded: Stage ACCELERATED PHASE, BLAST PHASE
Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 ^T315I
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor (imatinib, dasatinib, nilotinib) — chronic phase
Treatment with one of the following FDA approved TKIs; imatinib, dasatinib, nilotinib at any dose for a minimum of approximately three years (allowance of a four-week variance) prior to discontinuing TKIs
Must have received: tyrosine kinase inhibitor (imatinib, dasatinib, nilotinib) — retreatment after failed TKI discontinuation
After first failed TFR attempt, must have a minimum duration of one year of retreatment with TKI, and must plan to remain on that TKI or switch to asciminib for a minimum of 12 months during the consolidation treatment phase
Cannot have received: asciminib (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 ≥ 100 × 10^9/L; ANC ≥ 1 × 10^9/L; hemoglobin ≥ 8 g/dL
Kidney function
eGFR ≥ 30 mL/min (CKD-EPI equation)
Liver function
AST and ALT <3x ULN; total bilirubin <1.5x ULN (unless direct bilirubin is within normal limits)
Cardiac function
Screening 12-lead ECG showing baseline QTc ≤ 480 msec (≤ 500 msec if pacemaker)
Lipase ≤ 1.5 x ULN. AST and ALT <3x ULN. Total bilirubin <1.5x ULN (unless direct bilirubin is within normal limits). eGFR ≥ 30 mL/min. PLT ≥ 100 × 10^9/L; ANC ≥ 1 × 10^9/L; hemoglobin ≥ 8 g/dL. Screening 12-lead ECG showing a baseline corrected QT interval >480msec (patients with a pacemaker will still be eligible with QTc>500msec).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Barbara Ann Karmanos Cancer Institute · Detroit, Michigan
- Memorial Sloan Kettering Cancer Center · New York, New York
- Huntsman Cancer Institute · Salt Lake City, Utah
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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