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

RECRUITINGPhase 2Sponsored by Sichuan University
Actively Recruiting
PhasePhase 2
SponsorSichuan University
Started2023-09-10
Est. completion2024-08-31
Eligibility
Age16 Years – 65 Years
Healthy vol.Accepted

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

Age: 16 Years – 65 YearsHealthy volunteers accepted
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.

Conditions2

CancerLeukemia, Lymphoid

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