Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

• Status: Recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

1. patients diagnosed with B-ALL;

2. patients with age ≥ 16 years;

3. Availability of both pre- and post-transplantation disease status records.

Exclusion Criteria:

1. administration of blinatumomab therapy for more than 14 days;

2. patients with leukemia burden ≥ 10% before initiation of treatment;

3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;

4. patients with central nervous system leukemia.