Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

NCT06339775 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024318
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute B-cell Lymphoblastic Leukemia

Keywords

Acute B-cell lymphoblastic leukemia; Relapse; allogeneic hematopoietic stem cell transplantation; Blinatumomab

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Survival time of patients with recurrence after treatment

  three years

• Disease-free survival

  Disease-free survival time after treatment for relapsed patients

  three years

Secondary Outcomes (3)

• incidence of cytokine release syndrome （CRS）

  2 weeks later

• Incidence of acute/chronic graft-versus-host disease （GVHD）

  2 weeks later

• hematological adverse reactions Incidence rate

  2 weeks later

Study Arms (1)

Blinatumomab followed by donor lymphocyte infusion

EXPERIMENTAL

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).

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

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).

Also known as: donor lymphocyte infusion

Blinatumomab followed by donor lymphocyte infusion

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Suping ZHANG: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhilei BIAN

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suping ZHANG

CONTACT

+8613523510641; zsp198612@163.com

Zhilei BIAN

CONTACT

0371-66862272

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: visiting staff

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)