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

Leukemia, Lymphoid Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Recurrence

• NCT number: NCT06075238
• Study type: Interventional
• Source: Sichuan University
• Contact: Jie Ji, MD
• Phone: 86-28-85422373
• Email: jieji@scu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Completion date: September 30, 2026