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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 65
Healthy Volunteers: f
View:

• Age ≤65 years old

• Stable vital signs

• No severe infection

• There was no grade II-IV graft-versus-host disease

• No organ failure

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhenzhou
Contact Information
Primary
Suping ZHANG
zsp198612@163.com
+8613523510641
Backup
Zhilei BIAN
0371-66862272
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Blinatumomab followed by donor lymphocyte infusion
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).
Sponsors
Leads: Suping ZHANG

This content was sourced from clinicaltrials.gov

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