Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
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.
|Leukemia||Drug: 2-chlorodeoxyadenosine (CDA) daily Drug: 2-chlorodeoxyadenosine weekly||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia|
- Acute hematotoxicity at 10 weeks following study treatment [ Time Frame: 10 weeks ]
- Acute infection rate at 10 weeks following study treatment [ Time Frame: 10 weeks ]
- Hospital admission frequency and length at 10 weeks following study treatment [ Time Frame: 10 weeks ]
- Blood support at 10 weeks following study treatment [ Time Frame: 10 weeks ]
- Remission rate [ Time Frame: 10 weeks ]
- Remission duration [ Time Frame: 10 weeks ]
- Relapse-free survival [ Time Frame: 10 weeks ]
|Study Start Date:||September 1998|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Active Comparator: CDA day
CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
Drug: 2-chlorodeoxyadenosine (CDA) daily
Active Comparator: CDA week
CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
Drug: 2-chlorodeoxyadenosine weekly
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003746
|Bern, Switzerland, CH-3010|
|Study Chair:||Reinhard Zenhaeusern, MD||University Hospital Inselspital, Berne|