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

Plain Language Summary

Simplified for easier understanding

This study tests blinatumomab — a drug that directs the immune system to attack leukemia cells — for patients with relapsed acute B-cell lymphoblastic leukemia (a type of blood cancer) who have already received a bone marrow transplant. **You may be eligible if...** - You are 65 years old or younger - Your vital signs are stable - You do not have a severe active infection - You do not have significant graft-versus-host disease (a complication where the transplanted cells attack your body) - Your heart, liver, kidneys, and other organs are functioning adequately **You may NOT be eligible if...** - You are over 65 years old - You have unstable vital signs - You have a severe infection - You have grade II–IV graft-versus-host disease - You have organ failure (heart, liver, or kidney) - Cancer has spread to the central nervous system (brain/spinal cord) - You are allergic to medications in the treatment plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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