NCT06075212

Immune Reconstitution After Allo-HSCT and Blinatumomab

Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation. Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation. Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.

Conditions

• Leukemia, Lymphoid

Interventions

Type	Name	Description
DRUG	blinatumomab	The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-10-10
• Last updated: 2023-10-10