A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Jan 16, 2026
  • participants needed
    80
  • sponsor
    The First Affiliated Hospital of Soochow University
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Updated on 16 October 2022
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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

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.

Details
Condition B-cell Acute Lymphoblastic Leukemia
Treatment Conventional therapy, Blinatumomab
Clinical Study IdentifierNCT05559450
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on16 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission
ECOG score is 0-2
Expecting life span is more than 6 months
Patients are free from severe organ dysfunction

Exclusion Criteria

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
Patients are combined with infection or other complications that can not tolerate chemotherapy
Patients are suffering from central nervous system/solitary extramedullary leukemia
Patients are considered as tumer progression
Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks
Pregnant and lactating women will not be included
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