Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 17, 2012

Primary Completion Date

August 9, 2018

Study Completion Date

August 9, 2018

Conditions
Leukemia
Interventions
OTHER

Heavy Water (2H2O)

50 ml 70% 2H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765.

DRUG

PCI-32765

420 mg orally once 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