Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646666
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
ARTA-based Chemo-free BridgingMaintenance Therapy in CAR-T Treatment for High-Risk RR B-NHL Ineligible for HDCT and ASCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of All-trans Retinoic Acid ATRA-based Chemo-free Bridgingmaintenance Therapy in CAR-T Treatment of High-risk Relapsedrefractory B-NHL Ineligible for High-dose Chemotherapy HDCT and Autologous Stem Cell Transplantation ASCT
Status:
NOT_YET_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:
This is a single-center open-label prospective study enrolling high-risk tumor diameter 4 cm relapsedrefractory B-NHL patients ineligible for HDCT and ASCT The treatment consists of ATRA combined with zanubrutinib radiotherapy and CAR-T therapy Based on the efficacy at day 28 post-CAR-T infusion patients achieving CR will receive 3 months of ATRA and zanubrutinib while those with PR will receive 3 months of zanubrutinib plus 2 years of ATRA and a PD-1 inhibitor Patients with stable disease or progression will discontinue The primary endpoint is the 3-month CR rate following CAR-T infusion
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