Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Other SWS-SAKK-32/98 EU-98074, NCT00003746

Objectives

1. Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.

Entry Criteria

Disease Characteristics:

• Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL)



• Newly diagnosed HCL or progressive disease after prior treatment

Prior/Concurrent Therapy:

• At least 4 weeks since any prior therapy and recovered

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent cytoreductive therapy
• No prior cladribine

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• NCI 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 2.3 mg/dL

Other:

• HIV negative
• Not pregnant
• No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin

Expected Enrollment

A total of 120 patients will be accrued for this study within 4 years.

Outcomes

Acute hematotoxicity at 10 weeks following study treatment
Acute infection rate at 10 weeks following study treatment

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

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.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Reinhard Zenhaeusern, MD, Protocol chair		Ph: 41-31-632-4114

Registry Information
Official Title		Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients with Hairy Cell Leukemia
Trial Start Date		1998-09-28
Registered in ClinicalTrials.gov		NCT00003746
Date Submitted to PDQ		1998-01-12
Information Last Verified		2006-05-02

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