Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Swiss Group for Clinical Cancer Research

Status and phase: Completed; Phase 3

Conditions: Leukemia

Treatments: Drug: 2-chlorodeoxyadenosine (CDA) daily; Drug: 2-chlorodeoxyadenosine weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT00003746

SAKK 32/98

SWS-SAKK-32/98

EU-98074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CDA day

Active Comparator group

Description:

CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5

Treatment:

Drug: 2-chlorodeoxyadenosine (CDA) daily

CDA week

Active Comparator group

Description:

CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5

Treatment:

Drug: 2-chlorodeoxyadenosine weekly