🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07199855
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

NCT07199855 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase 2
Started
2025-06-01
Last updated
2025-09-30

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: 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

Sex
ALL
Min age
14 Years
Max age
65 Years
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

More Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199855 on ClinicalTrials.gov ↗ ← All trials in China