Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia

NCT07199855 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: IIT20250105C
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation .

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Keywords

Philadelphia chromosome-negative;; B-cell Acute Lymphoblastic Leukemia; Blinatumomab; Venetoclax; Allogeneic Hematopoietic Stem Cell Transplantation; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• 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

  the 2-year progression-free survival (PFS) rate post-transplantation

Secondary Outcomes (2)

• the 2-year cumulative relapse rate

  2 year after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

• 2-year overall survival (OS)

  2 year after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Study Arms (1)

blinatumomab combined with venetoclax as maintenance therapy

EXPERIMENTAL

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

Drug: blinatumomab combined with venetoclax as maintenance therapy

Interventions

blinatumomab combined with venetoclax as maintenance therapy DRUG

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

blinatumomab combined with venetoclax as maintenance therapy

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

venetoclax; Maintenance

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Hongyan Tong

  First Affiliated Hospital, Zhejiang University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)