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Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation | Clinical Trials | Clareo Health

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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

NCT07003737•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) according to the 2022 WHO classification.
•2\. Age between 18 and 65 years. 3. Meets the National Comprehensive Cancer Network (NCCN) criteria for high-risk B-ALL, based on clinical or cytogenetic/molecular features:
•1. Clinical high-risk features (any of the following):
•1. Age \> 35 years
•2. Peripheral WBC count \> 30 × 10⁹/L
•3. Cytogenetic/molecular high-risk features (any of the following):
•2. Cytogenetic and molecular high-risk features (at least one of the following):
•1. Hypodiploidy (\<44 chromosomes)
•2. TP53 mutation
•3. KMT2A rearrangement
+15 more criteria

Exclusion Criteria

•1. Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins.
•2. Clinically significant cardiovascular disease, including uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, NYHA class III or IV heart disease, or myocardial infarction within 3 months prior to screening.
•3. Other severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure).
•4. Known HIV infection or uncontrolled severe viral hepatitis.
•5. Pregnant or breastfeeding women.

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 5, 2025

Primary Completion Date

February 5, 2027

Completion Date

February 5, 2028

Last Updated

June 4, 2025

Enrollment

114

ESTIMATED participants

Conditions

Acute Lymphoblastic Leukemia, B-precursor

Interventions

Blinatumomab

DRUG

Consolidation Chemotherapy or Direct Allogeneic HSCT

OTHER

Contacts

Hengwei Wu Attending, MD

CONTACT

+8619858162455 wuhengwei@zju.edu.cn

T-cells Expressing Anti-CD19 CAR in Pediatric and Young Adults With B-cell Malignancies

NCT02772198

Acute Lymphoblastic Leukemia, B-precursorNon-Hodgkin Lymphoma, B-cell

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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