Status:
ACTIVE_NOT_RECRUITING
Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia
Lead Sponsor:
Zhejiang University
Conditions:
B-Cell Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief 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 chro...
Detailed Description
This study focuses on high-risk Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients. The primary objective is to evaluate the efficacy of blinatumomab combined ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07199855
Start Date
June 1 2025
End Date
July 1 2029
Last Update
September 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000