Acute lymphoblastic leukemia
Conditions
Interventions
Group A:Maintenance therapy withblinatumomab and venetoclax following allogeneic hematopoietic stem cell transplantation
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 14 and 65 years, with no restriction on sex or ethnicity. 2. Diagnosis: All enrolled patients must have a confirmed diagnosis of Philadelphia chromosome-negative acute B-lymphoblastic leukemia (Ph- B-ALL) based on bone marrow morphology, cytochemistry, immunophenotyping, cytogenetics, and gene mutation analysis. Patients must express the CD19 surface antigen. 3. Risk stratification: Inclusion of patients with high-risk B-ALL (as per NCCN Guidelines 2024.V2), and/or standard-risk B-ALL who (i) fail to achieve remission before transplantation, (ii) achieve first complete remission (CR1) but have measurable residual disease (MRD)-positive status, (iii) are in second or greater remission (>=CR2), and/or (iv) receive reduced-intensity conditioning (RIC) or non-myeloablative regimens. 4. Planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) with an eligible donor, including HLA-identical sibling donors, unrelated donors (9–10/10 matched at high-resolution HLA typing), or haploidentical family donors. 5. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) = 50%; Baseline oxygen saturation > 92%; Total bilirubin = 40%, FEV1 >= 50%. 8. Post-transplant hematopoietic reconstitution with full donor chimerism, platelet count > 50 × 10^9/L, absolute neutrophil count > 1.0 × 10^9/L, and hemoglobin > 80 g/L. 9. Informed consent: The patient and their legal guardian(s) must be capable of understanding and willing to participate in the study, sign the informed consent form, and comply with the treatment protocol, follow-up schedule, and required laboratory assessments.
Exclusion criteria
Exclusion criteria: 1. History of any malignancy other than acute lymphoblastic leukemia within the past 5 years, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer post-radical resection, or ductal carcinoma in situ post-radical treatment. 2. Patients with standard-risk B-ALL (per NCCN Guidelines 2024.V2) who are MRD-negative before transplantation. 3. Evidence of relapse or MRD positivity (>=0.01%) or loss of complete remission upon bone marrow reassessment within one week prior to initiating maintenance therapy. 4. Absolute CD3+ T-cell count <= 0.5 × 10^9/L prior to maintenance therapy. 5. Presence of active acute or chronic GVHD requiring systemic immunosuppressive therapy prior to maintenance therapy. 6. Any unstable systemic illness, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within 3 months prior to screening, myocardial infarction within 3 months, congestive heart failure (NYHA class = III), post-pacemaker implantation with ongoing arrhythmia requiring pharmacologic management, or significant hepatic, renal, metabolic, or pulmonary arterial hypertension. 7. Active, uncontrolled infection requiring intravenous antibiotic therapy. 8. Positive status for human immunodeficiency virus (HIV). 9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring antiviral treatment. 10. Individuals with psychiatric disorders or those unable to provide informed consent. 11. Patients with a history of substance abuse or chronic alcoholism that may interfere with protocol compliance or outcome assessment. 12. Pregnant or breastfeeding women, or men and women of childbearing potential unwilling to use effective contraception during the study and for 12 months following treatment. 13. Any other condition that, in the opinion of the investigators, renders the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival (PFS) after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year cumulative incidence of relapse after transplantation;2-year overall survival (OS) after transplantation;Incidence of acute graft-versus-host disease (aGVHD) within 180 days post-transplantation;Cumulative incidence of chronic graft-versus-host disease (cGVHD);GVHD-free, relapse-free survival (GRFS);Non-relapse mortality (NRM);Incidence of treatment-emergent adverse events (TEAEs), from the initiation of maintenance therapy to 3 months after its completion; | — |
Countries
China
Contacts
Public ContactHongyan Tong, Jiejing Qian
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed