Active, not recruiting
Phase 2
Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia
Condition(s) studied
B-Cell Acute Lymphoblastic Leukemia, Adult
Investigational drug(s) / intervention(s)
blinatumomab combined with venetoclax as maintenance therapy: blinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation
Study summary
This study is a single-center, single-arm, prospective clinical trial evaluating the efficacy and safety of blinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation .
Eligibility
Inclusion Criteria:
* Demographics : Patients aged 14-65 years, regardless of gender or race.
* Diagnosis : Confirmed Ph-negative acute B-cell lymphoblastic leukemia (Ph- B-ALL) through bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal analysis, and genetic mutation testing, with CD19 surface antigen expression.
* Risk Stratification :
High-risk B-ALL (per NCCN 2024.V2 guidelines) or Standard-risk B-ALL with no pre-transplant remission or Standard-risk B-ALL in first complete remission (CR1) with measurable residual disease (MRD) positivity or Standard-risk B-ALL with ≥CR2 or B-ALL patients receiving reduced-intensity or non-myeloablative conditioning.
* Transplant Eligibility : Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a suitable donor meeting: HLA-identical sibling donor or Unrelated donor (HLA 9-10/10 high-resolution matched) or Haploidentical related donor.
* HCT-CI Score : ≤2 (Hematopoietic Cell Transplantation-Specific Comorbidity Index).
* ECOG Performance Status : ≤2.
* Organ Function :
Serum creatinine ≤1.5×ULN Cardiac ejection fraction ≥50% Baseline SpO₂ \>92% Total bilirubin ≤1.5×ULN; ALT/AST ≤2.0×ULN Pulmonary DLCO (hemoglobin-adjusted) ≥40% and FEV1 ≥50%
* Post-Transplant Recovery :
Full donor chimerism Platelet count \>50×10⁹/L Absolute neutrophil count \>1.0×10⁹/L Hemoglobin \>80g/L - Informed Consent : Patient and legal guardian must provide written informed consent, comply with treatment protocols, follow-up visits, and laboratory assessments.
Exclusion Criteria:
* Prior Malignancy : History of malignancy other than acute lymphoblastic leukemia within 5 years, except for adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical resection, or ductal carcinoma in situ post-resection.
* MRD-Negative B-ALL : Standard-risk B-ALL with MRD-negative status pre-transplant (per NCCN 2024.V2).
* Disease Activity : Relapse of primary disease or CR/MRD positivity (≥0.01%) confirmed by bone marrow re-evaluation within 1 week before maintenance therapy.
* T-Cell Deficiency : Absolute CD3+ T-cell count ≤0.5×10⁹/L prior to maintenance therapy.
* Active GVHD : Concurrent acute/chronic GVHD requiring systemic immunosuppressive treatment.
* Unstable Systemic Diseases : Including but not limited to:
* Unstable angina or cerebrovascular accident/transient ischemic attack (within 3 months)
* Myocardial infarction (within 3 months)
* Congestive heart failure (NYHA Class ≥ III)
* Post-pacemaker implantation with severe arrhythmia requiring medication
* Uncontrolled hepatic/renal/metabolic diseases
* Pulmonary hypertension
* Active Infection : Uncontrolled infections requiring intravenous antibiotics. HIV : Positive human immunodeficiency virus status. Hepatitis : Active HBV/HCV requiring antiviral therapy.
* Psychiatric Conditions : Mental disorders or inability to provide informed consent.
* Substance Abuse : Drug addiction or chronic alcoholism affecting trial evaluation.
* Reproductive Status :
Pregnant/breastfeeding females Fertile patients unwilling to use contraception during treatment and 12 months post-treatment
\- Other : Conditions deemed inappropriate by investigators.
Primary outcome measure(s)
- the 2-year progression-free survival (PFS) rate post-transplantation — the 2-year progression-free survival (PFS) rate post-transplantation
evaluate the 2-year progression-free survival (PFS) rate post-transplantation of blinatumomab combined with venetoclax as maintenance therapy following allogeneic hematopoietic stem cell transplantation (allo-HSCT) in these patients
Trial sites (1)
| Facility | City | Region | Status |
| First Affiliated Hospital, Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
|
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