Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Early chronic phase: time from diagnosis to therapy ≤ 12 months.
• Late chronic phase: time from diagnosis to therapy \> 12 months.
• Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow.
• Accelerated phase CML: presence of any of the following features:
⁃ i. Peripheral or marrow blasts 15% or more. ii. Peripheral or marrow basophils 20% or more. iii. Thrombocytopenia \< 100 x 109/L unrelated to therapy. iv. Documented extramedullary blastic disease outside liver or spleen.
Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Fadi Haddad, MD
fhaddad@mdanderson.org
346-234-4135
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2027-03-07
Participants
Target number of participants: 50
Treatments
Experimental: Treatment with Olveremebatinib
Patients will receive single agent olverembatinib at a dose of 30 mg orally every other day (QOD)
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Ascentage Pharma Group Inc.