Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-03 @ 8:38 PM
Study NCT ID:
NCT05529069
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
Status:
RECRUITING
Status Verified Date:
2025-10
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:
To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).
Detailed Description:
PRIMARY OBJECTIVE:
• To determine the efficacy (overall response rate) and safety profile of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients
SECONDARY OBJECTIVE:
• To evaluate the survival (including overall and progression-free survival) of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients.
EXPLORATORY STUDIES:
•Exploratory studies are planned on the trial and the final analysis and methodology including bio-informatics analysis
• To determine the efficacy (overall response rate) and safety profile of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients
SECONDARY OBJECTIVE:
• To evaluate the survival (including overall and progression-free survival) of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients.
EXPLORATORY STUDIES:
•Exploratory studies are planned on the trial and the final analysis and methodology including bio-informatics analysis
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-07498 | OTHER | NCI-CTRP Clinical Trials Registry | View |