Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438796
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
Blinatumomab Maintenance After Allo-HSCT
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia a Multicenter Open-label Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia
Detailed Description:
Blinatumomab is a novel immunological antibody based on BiTE CD19 is a surface antigen expressed throughout the development of B lymphocytes making it an ideal target for immunotherapy Blinatumomab was approved by the FDA for the treatment of adults with relapsedrefractory cancers Open-label single-arm multicenter phase II clinical study BLAST study enrolling 116 adult patients with precursor B-ALL in complete hematologic remission after at least 3 doses of intense chemotherapy but persistently positive for Measurable Residual Disease MRD MRD 10-3 which is the first ALL international multicenter clinical trial In August 2022 Chinas National Medicines and Pharmaceutical Administration NMPA Approved Blinatumomab for the treatment of relapsedrefractory precursor B-cell ALL in adults
Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion and fewer prospective studies have been conducted in the area of maintenance therapy A prospective single-arm clinical study NCT02807883 with Blinatumomab as maintenance therapy up to 4 cycles after allogeneic transplantation concluded by MD Anderson in August 2021 had the primary endpoints of safety acute graft-versus-host disease aGVHD and non-relapse mortality NRM and the secondary endpoints of efficacy PFS OS etc a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab the interval between transplantation and the first cycle of Blinatumomab use was 78 days 44-105 57 of the patients completed 4 cycles of treatment the median follow-up was 143 months the 1-year NRM was 0 the incidence of grade 3-4 aGVHD was 5 the 1-year OS was 85 and the 1-year PFS was 71 There was a trend toward benefit in PFS and OS curves between the two groups Although this study is an exploratory study data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new better and safer option
Therefore the investigators conducted a multicenter randomized controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation
Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion and fewer prospective studies have been conducted in the area of maintenance therapy A prospective single-arm clinical study NCT02807883 with Blinatumomab as maintenance therapy up to 4 cycles after allogeneic transplantation concluded by MD Anderson in August 2021 had the primary endpoints of safety acute graft-versus-host disease aGVHD and non-relapse mortality NRM and the secondary endpoints of efficacy PFS OS etc a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab the interval between transplantation and the first cycle of Blinatumomab use was 78 days 44-105 57 of the patients completed 4 cycles of treatment the median follow-up was 143 months the 1-year NRM was 0 the incidence of grade 3-4 aGVHD was 5 the 1-year OS was 85 and the 1-year PFS was 71 There was a trend toward benefit in PFS and OS curves between the two groups Although this study is an exploratory study data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new better and safer option
Therefore the investigators conducted a multicenter randomized controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None