Blinatumomab before allogeneic stem cell transplant for MRD‑negative high‑risk B‑cell ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized trial enrolling adults with high‑risk, BCR::ABL1‑negative B‑cell acute lymphoblastic leukemia who have achieved measurable residual disease (MRD) negativity and are planned for allogeneic hematopoietic stem cell transplantation (allo‑HSCT). Eligible participants are randomized to receive a short course of blinatumomab consolidation prior to allo‑HSCT or to proceed directly to allo‑HSCT. Blinatumomab is a CD19/CD3 bispecific T‑cell engager previously shown to clear MRD in B‑ALL; the trial's primary endpoint is relapse‑free survival. The goal is to determine whether pre‑transplant intensification with blinatumomab improves long‑term outcomes compared with immediate transplantation.

Why it matters

Who can join: the full rules

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
   4. MLL rearrangement
   5. HLF rearrangement
   6. ZNF384 rearrangement
   7. MEF2D rearrangement
   8. MYC rearrangement
   9. BCR-ABL1-like (Ph-like) ALL, including:
   10. JAK pathway rearrangements (CRLF2r, EPORr, JAK1/2/3r, TYK2r, SH2B3 mutation, IL7R mutation, JAK1/2/3 mutations)
   11. ABL-class rearrangements (ABL1, ABL2, PDGFRA, PDGFRB, FGFR1)
   12. Other kinase fusions (e.g., NTRK3r, FLT3r, LYNr, PTK2Br)
   13. PAX5alt
   14. t(9;22)(q34.1;q11.2); BCR-ABL1 with IKZF1 mutation and/or prior chronic myeloid leukemia (CML)
   15. Intrachromosomal amplification of chromosome 21 (iAMP21)
   16. IKZF1 alteration
   17. 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.

       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.

Where it's running

• The First Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Hengwei Wu Attending, MD
• Email: wuhengwei@zju.edu.cn
• Phone: +8619858162455

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.