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

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

Recruiting
14-65 years
All
Phase 2

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Overview

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

Description

High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want 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.

Eligibility

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.

Study details
    B-cell Acute Lymphoblastic Leukemia

NCT05559450

The First Affiliated Hospital of Soochow University

27 January 2024

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