Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
Official title: Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia:Phrase II, Exploratory Study
Key Details
Gender
All
Age Range
14 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2025-08
Completion Date
2027-12-31
Last Updated
2025-08-06
Healthy Volunteers
No
Interventions
BITE and DLI
Blinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day,Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cell dose: 1 × 10⁷/kg
Locations (1)
First Affiliated Hospital of Zhejiang University
Hangzhou, China