Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
18 Years
N/A
Both
Leukemia
Trial Information
Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute hematotoxicity at 10 weeks following study treatment
Outcome Time Frame:
10 weeks
Safety Issue:
No
Principal Investigator
Reinhard Zenhaeusern, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 32/98
NCT ID:
NCT00003746
Start Date:
September 1998
Completion Date:
November 2010
Related Keywords:
- Leukemia
- untreated hairy cell leukemia
- progressive hairy cell leukemia, initial treatment
- prolymphocytic leukemia
- Leukemia
- Leukemia, Hairy Cell
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