Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 22, 2024

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2029

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Pirtobrutinib

"Initial treatment:~\- Pirtobrutinib 200 mg by mouth (PO) daily from Cycle 1 Day 1 until the end of Cycle 12. Each cycle is 28 days.~Re-treatment:~-Pirtobrutinib 200 mg PO daily continuously"

DRUG

Obinutuzumab

"Obinutuzumab is given intravenously from Cycle 7 to Cycle 12, for total 6 cycles during initial treatment only.~Initial treatment:~\- Obinutuzumab intravenous (IV) following the standard schedule from Cycle 6 through Cycle 12 (total 6 cycles: 100 mg on Cycle 6 Day 1, 900 mg on Cycle 6 Day 2, 1000 mg on Cycle 6 Day 8 and Cycle 6 Day 15, 1000 mg on Day 1 of Cycle 7 through Cycle 12)."

Trial Locations (4)

04074

New England Cancer Specialists, Scarborough

02215

Beth Israel Deaconess Medical Center, Boston

Brigham & Women's Hospital, Boston

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Loxo Oncology, Inc.

INDUSTRY

lead

Inhye Ahn

OTHER

NCT06333262 - Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter