The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP
NCT06390306 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-06-03
Summary
This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP).
Conditions
- Chronic Myeloid Leukemia
Interventions
- DRUG
-
Ponatinib
Ponatinib is recommended orally (PO) daily continuously on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
- DRUG
-
Azacitidine is recommended 75mg/m2 subcutaneously on days 1-7 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
- DRUG
-
Venetoclax is recommended orally (PO) daily on days 1-14 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
- DRUG
-
Olverembatinib
Olverembatinib is recommended orally (PO) every other day on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
collaborator OTHER -
Henan Cancer Hospital
collaborator OTHER_GOV -
Zhejiang University
collaborator OTHER -
Peking Union Medical College
collaborator OTHER -
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Beijing Chuiyangliu Hospital
collaborator OTHER_GOV -
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Qian Jiang, MD · Peking University People's Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2026-12-01
- Completion
- 2027-12-01
Countries
- China
Study Locations
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