Actively Recruiting

Phase 2
Age: 16Years - 65Years
All Genders
NCT06111625

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

Led by Sichuan University · Updated on 2023-11-01

20

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with B-cell acute lymphoblastic leukemia (B-ALL)
  • Age 16 years or older
  • Availability of disease status records before and after transplantation
Not Eligible

You will not qualify if you...

  • Use of blinatumomab therapy for more than 14 days
  • Leukemia burden of 10% or higher before treatment
  • Severe organ dysfunction such as myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction
  • Presence of central nervous system leukemia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610044

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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