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

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

Recruiting
16-65 years
All
Phase 2

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Overview

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

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.

Study details
    Leukemia
    Lymphoid

NCT06111625

Sichuan University

26 January 2024

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