OncoMatch/Clinical Trials/NCT06817720
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Is NCT06817720 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies olverembatinib for chronic myeloid leukemia.
Treatment: olverembatinib — To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR fusion with ABL1
diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase
Required: ABL1 fusion with BCR
diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase
Disease stage
Required: Stage EARLY CHRONIC PHASE
Excluded: Stage LATE CHRONIC PHASE, ACCELERATED PHASE, BLAST PHASE
early chronic phase: time from diagnosis to therapy ≤ 12 months. Excluded: late chronic phase (>12 months), accelerated phase, blast phase
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: tyrosine kinase inhibitor
Exception: ≤ 30 days of prior FDA approved TKI allowed
Participants who have received more than 30 days of prior FDA approved TKI
Cannot have received: antimetabolite (cytarabine)
Exception: ≤ 2 doses allowed
Participants who have received more than 2 doses of cytarabine
Cannot have received: chemotherapy
Exception: hydroxyurea, 1-2 doses cytarabine, ≤ 30 days TKI allowed
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 2 or better
adequate end organ function, defined as: 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; NYHA class 2 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 →Frequently asked questions
Is NCT06817720 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tyrosine kinase inhibitor, antimetabolite, chemotherapy disqualifies patients from enrollment.
Does this trial require BCR?
Yes, BCR fusion with ABL1 is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion with BCR is a required biomarker for enrollment.
What disease stage is eligible?
Stage EARLY CHRONIC PHASE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify