The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment. They have to be untreated so far or may be pretreated with alpha-interferon.
Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine. Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
Time frame: 4 months after treatment
Rate of complete remissions in patient who still have detectable residual disease
A second cycle of cladribine after an interval of 4 months following the first cycle.
Time frame: 4 months after treatment
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