Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Swiss Cancer Institute100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Leukemia

Interventions

2-chlorodeoxyadenosine (CDA) dailyDRUG

Daily administration

2-chlorodeoxyadenosine weeklyDRUG

Weekly administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Inselspital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

Acute hematotoxicity at 10 weeks following study treatment

Time frame: 10 weeks

Acute infection rate at 10 weeks following study treatment

Time frame: 10 weeks

Secondary Outcomes

Hospital admission frequency and length at 10 weeks following study treatment

Time frame: 10 weeks

Blood support at 10 weeks following study treatment

Time frame: 10 weeks

Remission rate

Time frame: 10 weeks

Remission duration

Time frame: 10 weeks

Relapse-free survival

Time frame: 10 weeks

Data from ClinicalTrials.gov

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