Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601831
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2020-10-09
Brief Title:
Re-Priming RT After Incomplete Response to CAR-T in RR NHL
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Phase III Trial of Re-Priming Radiation Therapy for RelapsedRefractory Non-Hodgkin Lymphoma Patients in Incomplete Response After Chimeric Antigen Receptor T-cell CAR-T Therapy
Status:
RECRUITING
Status Verified Date:
2024-01
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 single-arm open-label phase III trial studying the safety and efficacy of focal re-priming radiation therapy RT to FDG-avid residual sites of disease in relapsedrefractory non-Hodgkin lymphoma RR NHL patients with incomplete response IR to CAR T-cell therapy CAR-T by day 30 post-CAR-T PETCT We hypothesize that focal re-priming RT will be safe phase I and improve conversion to metabolic complete response CR by day 90 post-CAR-T PETCT from 29 historical control to 58 phase II
Detailed Description:
Early clinical trials of CAR-T in RR NHL suggest that only 40 of patients achieve CR by day 30 PETCT evaluation Of those who do not the large majority 70 ultimately fail while 30 convert to CR after a median time of 64 days range 49-424 This group of patients who have incomplete response on day 30 PETCT after CAR-T and thus are most likely to fail CAR-T alone may be the ideal target for early therapeutic intervention to re-prime CAR-T and convert them from IR to CR
Preclinical and early clinical studies suggest potential immune augmentation when combining RT with CAR-T Therefore we propose a phase III clinical trial investigating the impact of RT to poor responding sites of disease after CD19-directed CAR-T in RR NHL patients who are likely to fail CAR-T alone We hypothesize that focal RT to residual FDG-avid sites of disease on day 30 PETCT will improve the number of patients who convert to CR by day 90 PETCT both through local cytotoxic effects as well as local and systemic synergistic effects through re-priming of CAR T-cells
Preclinical and early clinical studies suggest potential immune augmentation when combining RT with CAR-T Therefore we propose a phase III clinical trial investigating the impact of RT to poor responding sites of disease after CD19-directed CAR-T in RR NHL patients who are likely to fail CAR-T alone We hypothesize that focal RT to residual FDG-avid sites of disease on day 30 PETCT will improve the number of patients who convert to CR by day 90 PETCT both through local cytotoxic effects as well as local and systemic synergistic effects through re-priming of CAR T-cells
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