Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Phase 3

Completed

• Conditions: Leukemia
• Interventions: Drug: 2-chlorodeoxyadenosine (CDA) daily; Drug: 2-chlorodeoxyadenosine weekly

• Registration Number: NCT00003746
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief 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.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-11
• Study Completion: 2010-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CDA day	2-chlorodeoxyadenosine (CDA) daily	CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
CDA week	2-chlorodeoxyadenosine weekly	CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5

Primary Outcome Measures

Name	Time	Method
Acute hematotoxicity at 10 weeks following study treatment	10 weeks
Acute infection rate at 10 weeks following study treatment	10 weeks

Secondary Outcome Measures

Name	Time	Method
Hospital admission frequency and length at 10 weeks following study treatment	10 weeks
Blood support at 10 weeks following study treatment	10 weeks
Remission rate	10 weeks
Remission duration	10 weeks
Relapse-free survival	10 weeks

Trial Locations

Locations (1)

Inselspital Bern; 🇨🇭 Bern, Switzerland