Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531046
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-26
First Post:
2020-08-25
Brief Title:
Axi-Cel as a 2nd Line Therapy in Patients With RelapsedRefractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
The Lymphoma Academic Research Organisation
Study Overview
Official Title:
Phase 2 Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With RelapsedRefractory Aggressive B-Non Hodgkin Lymphoma B-NHL Who Are Ineligible to Autologous Stem Cell Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
This is a phase 2 open-label multicenter study evaluating axicabtagene ciloleucel axi-cel as a 2nd line therapy in patients with RelapsedRefractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy
Detailed Description:
Axicabtagene ciloleucel axi-cel is a chimeric antigen receptor CAR T-cell therapy directed against CD19 which has been approved for the treatment of relapserefractory diffuse large B-cell lymphoma DLBCL and primary mediastinal large B-cell lymphoma PMBCL after 2 or more lines of systemic therapy
But administrating CAR T-cells earlier in the therapeutic strategy may be beneficial to patients
Axi-cel will improve the outcome of patients with DLBCL who are refractory or relapse early ie within 1 year from end of treatment after first-line therapy and who are not eligible for Autologous Stem Cell Transplantation ASCT
Transplant-ineligible patients will include those who are deemed ineligible for high-dose chemotherapy and Hematopoietic Stem Cell Transplantation HSCT due to age comorbidity or prior ASCT
The primary endpoint will be complete metabolic response CMR at 3 months after Axi-cel infusion
But administrating CAR T-cells earlier in the therapeutic strategy may be beneficial to patients
Axi-cel will improve the outcome of patients with DLBCL who are refractory or relapse early ie within 1 year from end of treatment after first-line therapy and who are not eligible for Autologous Stem Cell Transplantation ASCT
Transplant-ineligible patients will include those who are deemed ineligible for high-dose chemotherapy and Hematopoietic Stem Cell Transplantation HSCT due to age comorbidity or prior ASCT
The primary endpoint will be complete metabolic response CMR at 3 months after Axi-cel infusion
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?:
None
Is an FDA AA801 Violation?:
None