Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635330
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Safety and Efficacy of CAR T Cell Therapy in Patients with Rr B-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Single Arm Study Safety and Efficacy Assessment of the CD19 CAR T Cell on Pediatric Patients with Relapsing or Refractory B Cell Acute Lymphoblastic Leukemia rr B-ALL
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders aged 2 to 18 years with relapsing or refractory B cell acute lymphoblastic leukemia rr B-ALL The main questions it aims to answer are as following
1 What is the percentage of patients with overall remission rate ORR of complete response CR or complete remission with incomplete blood count recovery CRi
2 What is the rate of Event-free survival at first month and 2-3 months after intervention
3 What is the rate of Overall survival at first month and at 3 months after the intervention
1 What is the percentage of patients with overall remission rate ORR of complete response CR or complete remission with incomplete blood count recovery CRi
2 What is the rate of Event-free survival at first month and 2-3 months after intervention
3 What is the rate of Overall survival at first month and at 3 months after the intervention
Detailed Description:
B-cell acute lymphoblastic leukemia B-ALL as the most common type of pediatric tumor is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood Also relapse and refractory B-ALL RR B-ALL is the main reason of global mortality due to the constraints of combination chemotherapy
Over the past few years substantial advancements have been made in treatment of ALL specifically in the RR context Chimeric antigen receptor T CAR-T cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of rr B-ALL In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with RR B-ALL
Over the past few years substantial advancements have been made in treatment of ALL specifically in the RR context Chimeric antigen receptor T CAR-T cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of rr B-ALL In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with RR B-ALL
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