Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Recruiting now · Phase 4

Conditions studied: Acute B-cell Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID: NCT06339775
Run by: Suping ZHANG
People needed: 60
Starts: 2023-09-01
Expected to finish: 2027-06-30
Last updated by the study team: 2024-04-01

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The First Affiliated Hospital of Zhengzhou University — Zhenzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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