NCT00003746

Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.

Detailed description

OBJECTIVES: * 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 treatment arms. * 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 is evident. 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	2-chlorodeoxyadenosine (CDA) daily	Daily administration
DRUG	2-chlorodeoxyadenosine weekly	Weekly administration

Timeline

• Start date: 1998-09-01
• Primary completion: 2005-11-01
• Completion: 2010-11-01
• First posted: 2003-01-27
• Last updated: 2012-05-15

Locations

1 site across 1 country: Switzerland