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

Last updated: September 26, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Lymphocytic Leukemia, Acute

Treatment

N/A

Clinical Study ID

NCT05559450
2022019
  • Ages 14-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according tothe 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

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 orabove; 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 Creatinineclearance rate < 30ml/min.
  2. Patients are combined with infection or other complications that can not toleratechemotherapy.
  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 underwentautologous stem cell transplantation within 6 weeks or other immunotherapy within 4weeks.
  6. Pregnant and lactating women will not be included.

Study Design

Total Participants: 80
Study Start date:
February 01, 2022
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • The first affiliated hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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