Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339775
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-18
Brief Title:
Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation
Sponsor:
Suping ZHANG
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 28μg5-15 days followed by DLI treatment
MNC infusion is about 5107kg1108kg Patients with hematologic recurrence were given Blinatumomab 9μg D1-41166μg d5-728μg Starting from d8 8 to 21 days in total followed by DLI treatment infusion of MNC approximately 5107kg1108kg 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
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 28μg5-15 days followed by DLI treatment
MNC infusion is about 5107kg1108kg Patients with hematologic recurrence were given Blinatumomab 9μg D1-41166μg d5-728μg Starting from d8 8 to 21 days in total followed by DLI treatment infusion of MNC approximately 5107kg1108kg 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 28μg5-15 days followed by DLI treatment infusion of MNC is about 5107kg1108kg
Hematologic relapse patients were given Blinatumomab 9μg d1-41166μg d5-728μg d8 a total of 8 to 21 days followed by DLI treatment infusion of MNC is about 5107kg1108kg The duration of using Blinatumomab was determined according to the patients 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 acutechronic graft-versus-host disease GVHD after treatment incidence of infection incidence of hematological adverse reactions etcCompared with patients receiving usual care
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 28μg5-15 days followed by DLI treatment infusion of MNC is about 5107kg1108kg
Hematologic relapse patients were given Blinatumomab 9μg d1-41166μg d5-728μg d8 a total of 8 to 21 days followed by DLI treatment infusion of MNC is about 5107kg1108kg The duration of using Blinatumomab was determined according to the patients 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 acutechronic graft-versus-host disease GVHD after treatment incidence of infection incidence of hematological adverse reactions etcCompared with patients receiving usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None