RecruitingNot ApplicableNCT07003737

Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation

Short-term Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

114 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, randomized controlled trial designed to evaluate whether short-term blinatumomab intensification before allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve survival outcomes in adults with high-risk BCR::ABL1-negative B-cell acute lymphoblastic leukemia (B-ALL) who have achieved measurable residual disease (MRD) negativity. Blinatumomab, a CD19/CD3 bispecific T-cell engager, has shown promising efficacy in eradicating MRD and prolonging survival in B-ALL patients. In this study, eligible participants will be randomly assigned to receive either short-term blinatumomab consolidation prior to allo-HSCT or proceed directly to allo-HSCT. The primary endpoint is relapse-free survival (RFS). This study aims to optimize treatment strategies and improve long-term outcomes for patients with high-risk BCR::ABL1-negative B-ALL.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding blinatumomab — a drug that helps the immune system find and kill cancer cells — before a stem cell transplant improves outcomes for high-risk B-cell acute lymphoblastic leukemia (B-ALL) patients who have already achieved remission with no detectable disease (MRD-negative). **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) using 2022 WHO criteria - Your leukemia is classified as high-risk based on specific genetic or clinical features - Your cancer cells are CD19-positive and BCR-ABL1-negative - You achieved complete remission after initial treatment, with no detectable residual disease (MRD-negative) **You may NOT be eligible if...** - You do not have high-risk features as defined by NCCN guidelines - Your cancer cells are BCR-ABL1-positive - You have not achieved remission after initial treatment 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.

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Interventions

DRUGBlinatumomab

Blinatumomab is administered starting approximately one month before allogeneic hematopoietic stem cell transplantation (allo-HSCT). For participants weighing ≥45 kg: 9 μg/day is administered on Days 1-3, followed by 28 μg/day on Days 4-14. For participants weighing \<45 kg: 5 μg/m²/day (based on body surface area) is administered on Days 1-3, followed by 15 μg/m²/day on Days 4-14. The total dose must not exceed the dosage used for participants ≥45 kg.

OTHERConsolidation Chemotherapy or Direct Allogeneic HSCT

Participants in the Non-BiTE group will either proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT) or receive one additional cycle of consolidation chemotherapy prior to


Locations(1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07003737