NCT06075238

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

Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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. 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: 2026-09-30
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: China