Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263491
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-02-09
Brief Title:
Phase II Study of Pirtobrutinib Rituximab PR in Previously Untreated Low and Intermediate Risk MCL Mantle Cell Lymphoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Pirtobrutinib Rituximab PR in Previously Untreated Low and Intermediate Risk MCL Mantle Cell Lymphoma Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the chemotherapy-free combination of pirtobrutinib also called LOXO-305 and rituximab can help provide long term remission in low and intermediate risk MCL
Detailed Description:
Primary Objectives
To determine the efficacy measured by ORR CR PR at the end of cycle 3 of combination of PR Pirtobrutinib plus rituximab in MCL patients with low and intermediate risk
To determine the safety profile of Pirtobrutinib with rituximab combination in MCL participants with low and intermediate risk
Secondary Objectives
To evaluate the CR best overall response OR CR PR progression-free and overall survival from PR combination in MCL
To assess MRD negative CR rates
To determine the efficacy measured by ORR CR PR at the end of cycle 3 of combination of PR Pirtobrutinib plus rituximab in MCL patients with low and intermediate risk
To determine the safety profile of Pirtobrutinib with rituximab combination in MCL participants with low and intermediate risk
Secondary Objectives
To evaluate the CR best overall response OR CR PR progression-free and overall survival from PR combination in MCL
To assess MRD negative CR rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01325 | OTHER | NCI-CTRP Clinical Registry | None |