Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: First Affiliated Hospital of Wannan Medical College; Fujian Medical University Union Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First People's Hospital of Changzhou; Wuxi People's Hospital; Zhongda Hospital
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.

2. ECOG score is 0-2.

3. Expecting life span is more than 6 months.

4. Patients are free from severe organ dysfunction.

Exclusion Criteria:

1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure:

ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.

2. Patients are combined with infection or other complications that can not tolerate chemotherapy.

3. Patients are suffering from central nervous system/solitary extramedullary leukemia.

4. Patients are considered as tumer progression.

5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.

6. Pregnant and lactating women will not be included.