Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation
NCT ID: NCT06339775
Last Updated: 2024-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2023-09-01
2027-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Blinatumomab followed by donor lymphocyte infusion
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).
Blinatumomab
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).
Interventions
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Blinatumomab
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
ALL
No
Sponsors
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Suping ZHANG
OTHER
Responsible Party
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Suping ZHANG
visiting staff
Principal Investigators
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Zhilei BIAN
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, China
Countries
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Central Contacts
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Zhilei BIAN
Role: CONTACT
Facility Contacts
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Zhilei BIAN
Role: backup
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2024318
Identifier Type: -
Identifier Source: org_study_id
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