175
Participants
Start Date
October 20, 2008
Primary Completion Date
July 15, 2024
Study Completion Date
January 31, 2030
Cladribine
Cladribine 0.15 mg/Kg/day by 2-hour intravenous (i.v.) infusion days 1-5. The infusion time may be changed to 1 hour at the discretion of the principal investigator (PI).
Rituximab
Rituximab 375 mg/m\^2 intravenous (i.v.) infusion every week x8, begin day 1 in half of randomized patients and in all hairy cell leukemia variant (HCLv) patients, and then again in all patients at least 6 months later when hairy cell leukemia (HCL) is detected by blood fluorescence-activated cell sorting (FACS).
BMbx
Baseline and week 5.
MRI
Baseline and week 5.
EKG
Baseline and week 5.
Echocardiogram
Baseline.
Abdominal/splenic ultrasound
Baseline and week 5.
Stress test
Baseline.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH