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RECRUITING
NCT06111625
PHASE2

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

Sponsor: Sichuan University

View on ClinicalTrials.gov

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.

Official title: Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden

Key Details

Gender

All

Age Range

16 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-09-10

Completion Date

2026-08-31

Last Updated

2023-11-01

Healthy Volunteers

No

Interventions

DRUG

blinatumomab

Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China