drugset / Trial / NCT06075238

Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

NCT06075238

Phase 2 Not yet recruiting 68 enrolled Sichuan University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this phase I/II clinical trial 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: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. 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
2023-10-01
Primary completion
2024-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 16 ug Intravenous

Indications