Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 9:43 PM
Study NCT ID:
NCT05734495
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2023-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Study Evaluating Venetoclax and Pirtobrutinib in Previously Treated Waldenström Macroglobulinemia
Status:
RECRUITING
Status Verified Date:
2025-04
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 study is being done to examine the safety and effectiveness of pirtobrutinib combined with venetoclax as a possible treatment for participants with Waldenström Macroglobulinemia (WM).
The names of the study drugs involved in this study are:
* Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor)
* Venetoclax (a BCL2 inhibitor)
The names of the study drugs involved in this study are:
* Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor)
* Venetoclax (a BCL2 inhibitor)
Detailed Description:
This is a single-arm, open-label, Phase II study to evaluate the safety and efficacy of venetoclax combined with pirtobrutinib (VEN-P) in participants with symptomatic Waldenström Macroglobulinemia (WM) with previously treated disease. Pirtobrutinib blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps cells live and grow. Venetoclax blocks BCL-2, a protein essential for WM cells' survival.
The U.S. Food and Drug Administration (FDA) has not approved pirtobrutinib for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.
The FDA has not approved venetoclax for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.
The FDA has not approved the combination of pirtobrutinib and venetoclax as a treatment for any disease.
Study procedures include screening for eligibility, treatment visits, CT scans, blood tests, and bone marrow aspirates and biopsies.
Participants will receive study treatment for up to 2 years and will be followed for up to 4 years or until they start a new therapy.
It is expected that about 42 people will take part in this research study.
Eli Lilly supports this research study by providing study drug pirtobrutinib and funding.
The U.S. Food and Drug Administration (FDA) has not approved pirtobrutinib for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.
The FDA has not approved venetoclax for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.
The FDA has not approved the combination of pirtobrutinib and venetoclax as a treatment for any disease.
Study procedures include screening for eligibility, treatment visits, CT scans, blood tests, and bone marrow aspirates and biopsies.
Participants will receive study treatment for up to 2 years and will be followed for up to 4 years or until they start a new therapy.
It is expected that about 42 people will take part in this research study.
Eli Lilly supports this research study by providing study drug pirtobrutinib and funding.
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?: