Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Conditions
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Hairy Cell Leukemia

Intervention / Treatment
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* Drug: Cladribine s.c. injection, HCL treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically verified hairy cell leukemia Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7) No previous cytostatic treatment (splenectomy or interferon treatment are allowed) Need for treatment Age at least 18 years old General state of health according to WHO 0-2 Current histology, not older than 6 months Written consent by patient Exclusion Criteria: Patients not fulfilling inclusion criteria above Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25 Pretreatment with purine analogues or other chemotherapeutics Concomitant corticosteroid therapy Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses. Proven HIV infection Active Hepatitis Other florid infections Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix) Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cladribine s.c. injection, HCL treatment<br>Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment | Drug: Cladribine s.c. injection, HCL treatment<br>* 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<br>* Other names: 2-CdA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the rate of complete remissions after one cycle with subcutaneous cladribine |  | 4 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hairy cell leukemia, untreated, cladribine subcutaneous