Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 1, 2018

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2028

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Venetoclax

On cycle 1, day 1, patients will initiate venetoclax. The dose of venetoclax will ramp-up from 20 mg PO daily to 400 mg PO daily over a 5 week period.

DRUG

Ibrutinib

"During the screening period, patients will continue on ibrutinib at their previous tolerated dose, unless required to stop (e.g.: by a preceding clinical trial).~On cycle 1, day 1, the dose of ibrutinib will be assigned based on the dose cohort. Patients in cohort 1 will receive ibrutinib 420 mg PO daily. Patients in cohort 2 will receive ibrutinib 560 mg PO daily. Cohort 3 will be 840 mg PO daily."

Trial Locations (1)

92093

UC San Diego Moores Cancer Center, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Michael Choi

OTHER