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NCT Number: NCT06339775

Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

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.

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Key information

Conditions

Acute B-cell Lymphoblastic Leukemia Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

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

Exclusion criteria

  • Age >65 years old
  • Unstable vital signs
  • Complicated with severe infection
  • Complicated with grade II-IV graft-versus-host disease
  • Organ failure such as heart, liver, kidney, etc.
  • Complicated with central nervous system leukemia
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Other names: donor lymphocyte infusion

Primary outcomes

  1. Overall survival

    Time frame: three years

    Survival time of patients with recurrence after treatment

  2. Disease-free survival

    Time frame: three years

    Disease-free survival time after treatment for relapsed patients

Secondary outcomes

  1. incidence of cytokine release syndrome （CRS）

    Time frame: 2 weeks later

    Recurrent patients received treatment 2 weeks later

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

    Time frame: 2 weeks later

    Recurrent patients received treatment 100 days later.

  3. hematological adverse reactions Incidence rate

    Time frame: 2 weeks later

    Recurrent patients received treatment 2 weeks later.

Study contacts

Contact information is provided by the study sponsor or research team.

Suping ZHANG

CONTACT

[email protected]

+8613523510641

Zhilei BIAN

CONTACT

0371-66862272

Sponsors and collaborators

Lead sponsor

Suping ZHANG

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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