Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575374
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
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:
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation
Detailed Description:
Primary Objective
Estimate the probabilities at days d 28 and 98 following CAR T cell infusion among patients alive at the day of evaluation of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care SOC axicabtagene ciloleucel AXI-CEL therapy using the cutoff CMV DNA qPCR c for c 400 and 1000 IUmL to define CMV reactivation for a total of four d c combinations
Secondary Objectives
Estimate overall survival probabilities at days28 98 and 364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy
Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation
Estimate the probabilities at days d 28 and 98 following CAR T cell infusion among patients alive at the day of evaluation of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care SOC axicabtagene ciloleucel AXI-CEL therapy using the cutoff CMV DNA qPCR c for c 400 and 1000 IUmL to define CMV reactivation for a total of four d c combinations
Secondary Objectives
Estimate overall survival probabilities at days28 98 and 364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy
Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation
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