Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
- Compare the acute hematotoxicity and infection rate with daily and weekly
administration of cladribine in patients with hairy cell leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
- Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5
days (standard dose).
- Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.
Patients showing complete or partial remission at evaluation on day 71 of the first
treatment course do not receive any further treatment until relapse or disease progression
Patients showing minor or no response on day 71 of the first treatment course receive a
subsequent course of standard dose 2-CDA.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 4 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute hematotoxicity at 10 weeks following study treatment
Reinhard Zenhaeusern, MD
University Hospital Inselspital, Berne