Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Drug: 2-chlorodeoxyadenosine (CDA) daily
* Drug: 2-chlorodeoxyadenosine weekly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CDA day<br>CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5 | Drug: 2-chlorodeoxyadenosine (CDA) daily<br>* Daily administration<br>|
| Active Comparator: CDA week<br>CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5 | Drug: 2-chlorodeoxyadenosine weekly<br>* Weekly administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute hematotoxicity at 10 weeks following study treatment |  | 10 weeks | 
| Acute infection rate at 10 weeks following study treatment |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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untreated hairy cell leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia