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RecruitingPhase 4NCT06339775

Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor

Suping ZHANG

Enrollment

60 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Acute B-cell Lymphoblastic Leukemia

Summary

B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab. Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI. Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.

Eligibility

Max Age: 65 Years

Inclusion Criteria5

  • Age ≤65 years old
  • Stable vital signs
  • No severe infection
  • There was no grade II-IV graft-versus-host disease
  • No organ failure

Exclusion Criteria7

  • Age \> 65 years old
  • Unstable vital signs
  • Complicated with severe infection
  • Combined with grade Ⅱ-Ⅳ graft-versus-host disease
  • Heart, liver, kidney and other organ failure
  • Complicated with central nervous system leukemia
  • Allergies to medications in the treatment regimen

Interventions

DRUGBlinatumomab

patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg).

Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, China

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NCT06339775