Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
2-chlorodeoxyadenosine (CDA) daily
+ 2-chlorodeoxyadenosine weekly
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: September 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location