Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522386
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
GATE1 A Multicenter Phase II Study of Pirtobrutinib Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
GATE1 A Multicenter Phase II Study of Pirtobrutinib Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
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:
Primary Objectives
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL
Detailed Description:
Secondary Objectives
To evaluate the objective response rate to PRV combination therapy in patients with previously untreated MCL
To evaluate the duration of response in patients with an objective response to PRV combination therapy
To evaluate the progression-free survival and overall survival in patients treated with PRV combination therapy
To evaluate the safety profile of PRV combination therapy in patients with previously untreated MCL
To evaluate the objective response rate to PRV combination therapy in patients with previously untreated MCL
To evaluate the duration of response in patients with an objective response to PRV combination therapy
To evaluate the progression-free survival and overall survival in patients treated with PRV combination therapy
To evaluate the safety profile of PRV combination therapy in patients with previously untreated MCL
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