Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 27, 2012

Primary Completion Date

August 9, 2018

Study Completion Date

August 9, 2018

Conditions
Leukemia
Interventions
DRUG

Rituximab

375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.

DRUG

PCI-32765

420 mg (3 \* 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01520519 - Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients | Biotech Hunter | Biotech Hunter