Acute Lymphoblastic Leukemia, B-precursorNCT07003737
Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Blinatumomab and Consolidation Chemotherapy or Direct Allogeneic HSCT in people with Acute Lymphoblastic Leukemia, B-precursor, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B-precursor
- What is being tested?
- Blinatumomab and Consolidation Chemotherapy or Direct Allogeneic HSCT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 5 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
Who cannot join
- 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 severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure).
- Known HIV infection or uncontrolled severe viral hepatitis.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hengwei Wu, 19858162455, wuhengwei@zju.edu.cn
About this study
Official title: Short-term Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Study
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.
- Being tested
- Blinatumomab, Consolidation Chemotherapy or Direct Allogeneic HSCT
- Keywords
- allogeneic hematopoietic stem cell transplantation, measurable residual disease, Blinatumomab, high-risk BCR::ABL1-negative
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
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.
Consolidation Chemotherapy or Direct Allogeneic HSCTOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Non-BiTE group) | Sham comparator | Patients proceed directly to allo-HSCT without blinatumomab intensification. Receives: Other: Consolidation Chemotherapy or Direct Allogeneic HSCT |
| Blinatumomab Group (BiTE group) | Experimental | Patients receive short-term blinatumomab intensification before undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Relapse-Free Survival (RFS)
Relapse-free survival is defined as the time from transplantation to either disease relapse or death from any cause, whichever occurs first. Patients who are alive and relapse-free at 2 years will be considered as having achieved 2-year RFS.
Measured: 2 years after transplantation
Secondary outcomes (5)
Cumulative Incidence of Relapse (CIR)
Defined as the cumulative incidence of hematologic relapse, accounting for competing risks such as non-relapse mortality.
Measured: Up to 2 years after transplantation
Non-Relapse Mortality (NRM)
Death from any cause without prior hematologic relapse.
Measured: Up to 2 years after transplantation
Incidence of Hematologic and Non-Hematologic Adverse Events
Safety evaluation based on CTCAE v5.0 criteria, including treatment-related cytopenias, infections, neurotoxicity, and other adverse events.
Measured: From first dose of study drug to 100 days post-transplant
Measurable Residual Disease (MRD) Status
MRD status assessed using multi-parameter flow cytometry or PCR prior to HSCT. Evaluated as MRD-negative or MRD-positive.
Measured: From enrollment to up to 2 years after transplantation
2-year Overall Survival (OS)
Overall survival is defined as the time from HSCT to death from any cause. Patients alive at 2 years are considered to have achieved 2-year OS.
Measured: 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start5 Feb 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, B-precursorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Children's Hospital of Zhejiang University School of Medicine
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003737
- Sponsor's protocol ID
- BLI4MRD-BALL
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided