Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Trial Title: Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

NCT ID: NCT06339775

Condition: Acute B-cell Lymphoblastic Leukemia

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab

Conditions: Keywords:
Acute B-cell lymphoblastic leukemia
Relapse
allogeneic hematopoietic stem cell transplantation
Blinatumomab

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Blinatumomab
Description: 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).
Arm group label: Blinatumomab followed by donor lymphocyte infusion

Other name: donor lymphocyte infusion

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.

Detailed description: Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled. 1. Age ≤65 years old 2. Stable vital signs 3. No severe infection 4. No grade II-IV graft-versus-host disease 5. No organ failure Exclusion criteria 1. Age >65 years old 2. Unstable vital signs 3. Complicated with severe infection 4. Complicated with grade II-IV graft-versus-host disease 5. Organ failure such as heart, liver, kidney, etc. 6. Complicated with central nervous system leukemia 7. Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI. MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 （a total of 8 to 21 days）, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors. Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome （CRS）, incidence of acute/chronic graft-versus-host disease （GVHD） after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≤65 years old 2. Stable vital signs 3. No severe infection 4. There was no grade II-IV graft-versus-host disease 5. No organ failure Exclusion Criteria: 1. Age > 65 years old 2. Unstable vital signs 3. Complicated with severe infection 4. Combined with grade Ⅱ-Ⅳ graft-versus-host disease 5. Heart, liver, kidney and other organ failure 6. Complicated with central nervous system leukemia 7. Allergies to medications in the treatment regimen

Gender: All

Minimum age: N/A

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhenzhou
Zip: 450000
Country: China

Status: Recruiting

Contact:
Last name: Suping ZHANG

Phone: +8613523510641
Email: zsp198612@163.com

Contact backup:
Last name: Zhilei BIAN

Phone: 037166862272

Start date: September 1, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Suping ZHANG
Agency class: Other

Source: The First Affiliated Hospital of Zhengzhou University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06339775