Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cladribine

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