Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia
- Sponsor
- Zhejiang University
- Study ID
- NCT07199855
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- B-Cell Acute Lymphoblastic Leukemia, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 14 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- blinatumomab combined with venetoclax as maintenance therapy — DRUGblinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation
Study Details
This study is a single-center, single-arm, prospective clinical trial evaluating the efficacy and safety of blinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation .
Key Dates
- Start date
- Jun 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Jun 1, 2027
- Completion
- Jul 1, 2029
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: blinatumomab combined with venetoclax as maintenance therapyblinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation
Primary Outcome Measure
the 2-year progression-free survival (PFS) rate post-transplantation [ Time Frame: the 2-year progression-free survival (PFS) rate post-transplantation ]
Related Studies
- A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic LeukemiaPHASE1/PHASE2 · Not Yet Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York