Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581081
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T S1904 Cell Therapy for rr B-cell Acute Lymphoblastic Leukemia a Prospective Open Multicenter Randomized Control Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T S1904 Cell Therapy for rr B-cell Acute Lymphoblastic Leukemia a Prospective Open Multicenter Randomized Control Study COMPLETE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory RR B-cell acute lymphoblastic leukemia B-ALL Targeted CD19 CAR-T cell immunotherapy is an effective means of treating RR B-ALL Several clinical studies have shown that its remission rate for RR B-ALL can reach 68-93 However long-term follow-up found that the remission time after CD19 CAR-T treatment is short and the relapse rate is high Therefore how to ensure the long-term survival of RR B-ALL patients after remission by CAR-T therapy is an urgent problem to be solved Some studies have shown that timely bridging allo-HSCT after CAR-T treatment can overcome the risk of relapse and further improve the long-term survival of patients However there is currently no randomized controlled study on whether to bridge transplantation after CAR-T The purpose of this study is to evaluate the efficacy and safety of S1904 in the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia with or without bridging to allogeneic hematopoietic stem cell transplantation after remission
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None