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

Recruiting now · Phase 2

Conditions studied: Leukemia, Lymphoid

In brief

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.

Key facts

Study ID

NCT06111625

Run by

Sichuan University

People needed

20

Starts

2023-09-10

Expected to finish

2026-08-31

Last updated by the study team

2023-11-01

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients diagnosed with B-ALL;
• patients with age ≥ 16 years;
• Availability of both pre- and post-transplantation disease status records.

You may not qualify if…

• administration of blinatumomab therapy for more than 14 days;
• patients with leukemia burden ≥ 10% before initiation of treatment;
• patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;
• patients with central nervous system leukemia.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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