Hairy Cell Leukemia
Conditions
Keywords
hairy cell leukemia, untreated, cladribine subcutaneous
Brief summary
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
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.
Interventions
DRUGCladribine s.c. injection, HCL treatment
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
Sponsors
University of Giessen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the rate of complete remissions after one cycle with subcutaneous cladribine | 4 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete remissions in patient who still have detectable residual disease | 4 months after treatment | A second cycle of cladribine after an interval of 4 months following the first cycle. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall effectiveness | 20 years | Determination of: * overall remission rate * duration of remission * immunodeficiency induced by treatment, its duration, infectious and other complications resulting from that * frequency of secondary neoplasia during life long follow up * overall survival |
| Improvement of remission deepness | Date of staging after first cycle + 4 months | Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle? |
| Improvement of remission quality | Date of staging after first cycle + 4 months | Can the quality of remission achieved with the first cycle be improved with a second cycle? |
| Lowering risk of relapse | Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 years | Can the expected risk of relapse be lowered and the duration of remission be prolonged? |
Countries
Germany
Contacts
Primary ContactMathias J Rummel, Prof PhD
Backup ContactJuergen Barth
Outcome results
None listed