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.

Condition	Treatment or Intervention	Phase
untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment Prolymphocytic Leukemia	Drug: cladribine  Procedure: chemotherapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL)
• Newly diagnosed HCL or progressive disease after prior treatment

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

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

Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland; Recruiting

Study chairs or principal investigators

Reinhard Zenhaeusern, MD,  Study Chair,  Inselspital, Bern   

Study ID Numbers:  CDR0000066865; SWS-SAKK-32/98; EU-98074; NCT00003746
Record last reviewed:  August 1999
Last Updated:  December 6, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003746
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08