Actively Recruiting
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
50
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Ascentage Pharma Group Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.
CONDITIONS
Official Title
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants age 18 years or older
- Diagnosis of Philadelphia chromosome-positive or BCR::ABL1 positive CML in early chronic phase
- Prior hydroxyurea, 1 to 2 doses of cytarabine, and/or FDA-approved TKI for 30 days or less allowed
- Additional chromosomal abnormalities allowed if no accelerated phase criteria
- ECOG performance status 2 or better
- Adequate organ function including bilirubin, liver enzymes, and creatinine clearance thresholds
- Ability to understand and sign informed consent
- Agreement to use adequate contraception if of child-bearing potential
- Undetectable HBV viral load on suppressive therapy if applicable
- Treated and cured HCV infection or on treatment with undetectable viral load
- Treated brain metastases with no progression on follow-up imaging
- Prior or concurrent malignancy allowed if not interfering with safety or efficacy
- Cardiac function classified as NYHA class 2 or better
You will not qualify if you...
- More than 30 days of prior FDA-approved TKI or more than 2 doses of cytarabine
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for certain agents) before study
- Unrecovered adverse events from prior anti-cancer therapy except alopecia
- Receiving other investigational agents
- Allergic reactions to olverembatinib or similar compounds
- NYHA cardiac class 3 or 4 heart disease
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- History of significant ventricular arrhythmias
- Prolonged QTc interval over 460 msec
- Significant bleeding disorders unless cleared by specialist
- Active uncontrolled psychiatric disorders or cognitive impairment limiting compliance
- Evidence of uncontrolled infection or active hepatitis B or C with detectable virus
- Pregnant or breastfeeding women
- Late chronic phase (diagnosis to treatment over 12 months), accelerated or blast phase CML
- Documented extramedullary blastic disease outside liver or spleen
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fadi Haddad, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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