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

Last updated: October 27, 2023
Sponsor: Sichuan University
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Treatment

blinatumomab

Clinical Study ID

NCT06111625
Blin-bridge 1.0
  • Ages 16-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 myocardialinfarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction,or gastrointestinal dysfunction;
  4. patients with central nervous system leukemia.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: blinatumomab
Phase: 2
Study Start date:
September 10, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610044
    China

    Active - Recruiting

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