RecruitingPhase 2NCT06111625

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

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


Sponsor

Sichuan University

Enrollment

20 participants

Start Date

Sep 10, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether using blinatumomab — an antibody that directs immune cells to attack leukemia cells — as a short bridge therapy before a stem cell transplant from a donor improves outcomes in patients with B-cell acute lymphoblastic leukemia (B-ALL) who have a low amount of remaining cancer. **You may be eligible if...** - You have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) - You are 16 years or older - You have records of your disease status both before and after the transplant **You may NOT be eligible if...** - You received blinatumomab for more than 14 days - Your leukemia burden was 10% or higher before starting treatment - You had severe organ dysfunction (heart failure, liver failure, kidney failure) before treatment - You had leukemia in your central nervous system (brain or spinal fluid) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGblinatumomab

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06111625


Related Trials