NCT07003737 Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07003737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Acute Lymphoblastic Leukemia, B-precursor |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2025-02-05 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07003737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Lymphoblastic Leukemia, B-precursor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07003737 currently recruiting?
Yes, NCT07003737 is actively recruiting participants. Contact the research team at wuhengwei@zju.edu.cn for enrollment information.
Where is the NCT07003737 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07003737 clinical trial?
NCT07003737 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 114 participants.
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