Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466122
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-07
Brief Title:
Pirtobrutinib LOXO-305 and Venetoclax for the Treatment of Patients With CLL or SLL Resistant to Covalent BTKi
Sponsor:
Kerry Rogers
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase 2 Study of Combination Pirtobrutinib LOXO-305 and Venetoclax in CLL Patients With Resistance to Covalent BTKi
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This phase II trial tests how well pirtobrutinib LOXO-305 and venetoclax works in treating patients with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL that remains despite treatment resistant with covalent bruton tyrosine kinase inhibitors BTKi Pirtobrutinib is in a class of medications called kinase inhibitors It works by blocking the action of the a protein that signals cancer cells to multiply Venetoclax is in a class of medications called B-cell lymphoma-2 BCL-2 inhibitors It may stop the growth of cancer cells by blocking BCL-2 a protein needed for cancer cell survival Giving pirtobrutinib and venetoclax may kill more cancer cells in patients with CLL or SLL that is resistant to covalent BTKi
Detailed Description:
PRIMARY OBJECTIVE
I Determine if combination pirtobrutinib and venetoclax can induce undetectable minimal residual disease uMRD in CLL patients with resistance to ibrutinib acalabrutinib or zanubrutinib
OUTLINE
Patients receive pirtobrutinib orally PO once daily QD on days 1-28 of each cycle and receive venetoclax PO QD on days 1-28 of cycles 2-20 Cycles repeat every 28 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity Patients who experience disease progression within 12 months of stopping combination treatment may receive pirtobrutinib PO QD in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection bone marrow aspiration and biopsy and computed tomography CT throughout the study
After completion of study treatment patients are followed up every 6 months
I Determine if combination pirtobrutinib and venetoclax can induce undetectable minimal residual disease uMRD in CLL patients with resistance to ibrutinib acalabrutinib or zanubrutinib
OUTLINE
Patients receive pirtobrutinib orally PO once daily QD on days 1-28 of each cycle and receive venetoclax PO QD on days 1-28 of cycles 2-20 Cycles repeat every 28 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity Patients who experience disease progression within 12 months of stopping combination treatment may receive pirtobrutinib PO QD in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection bone marrow aspiration and biopsy and computed tomography CT throughout the study
After completion of study treatment patients are followed up every 6 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04627 | REGISTRY | None | None |