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NCT07003737Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
114 (estimated)
First submitted
27 May 2025
Start date
5 Feb 2025
Primary completion date
5 Feb 2027
Lead sponsor
First Affiliated Hospital of Zhejiang University
NCT number
NCT07003737

What you commit to

  • Study type: Interventional
  • Planned participants: 114
  • From 5 Feb 2025 to the primary completion date, 5 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins.
  • 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.

Other illness

  • Other severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure).
  • Known HIV infection or uncontrolled severe viral hepatitis.

Other

  • Pregnant or breastfeeding women.

Who the study is looking for

  • 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:
  • Clinical high-risk features (any of the following):
    • Age \> 35 years
    • Peripheral WBC count \> 30 × 10⁹/L
    • Cytogenetic/molecular high-risk features (any of the following):
  • Cytogenetic and molecular high-risk features (at least one of the following):
    • Hypodiploidy (\<44 chromosomes)
    • TP53 mutation
    • KMT2A rearrangement
    • MLL rearrangement
    • HLF rearrangement
    • ZNF384 rearrangement
    • MEF2D rearrangement
    • MYC rearrangement
    • BCR-ABL1-like (Ph-like) ALL, including:
    • JAK pathway rearrangements (CRLF2r, EPORr, JAK1/2/3r, TYK2r, SH2B3 mutation, IL7R mutation, JAK1/2/3 mutations)
    • ABL-class rearrangements (ABL1, ABL2, PDGFRA, PDGFRB, FGFR1)
    • Other kinase fusions (e.g., NTRK3r, FLT3r, LYNr, PTK2Br)
    • PAX5alt
    • t(9;22)(q34.1;q11.2); BCR-ABL1 with IKZF1 mutation and/or prior chronic myeloid leukemia (CML)
    • Intrachromosomal amplification of chromosome 21 (iAMP21)
    • IKZF1 alteration
    • Complex karyotype (≥5 chromosomal abnormalities) 4. CD19-positive by immunophenotyping. 5. BCR::ABL1-negative. 6. Achieved complete remission (CR) after induction therapy. 7. Measurable residual disease (MRD)-negative by flow cytometry (FCM). 8. Availability of a matched sibling donor, haploidentical related donor, or matched/unmatched unrelated donor.
    • 9\. ECOG performance status score of 0-2. 10. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault formula). 11. AST and ALT ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. 12. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography. 13. Expected survival \> 8 weeks. 14. Signed written informed consent, with ability to understand and comply with the study protocol.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status		HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.