Therapy Optimisation for the Treatment of Hairy Cell Leukemia
- Conditions
- Hairy Cell Leukemia
- Interventions
- Registration Number
- NCT02131753
- Lead Sponsor
- University of Giessen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cladribine s.c. injection, HCL treatment Cladribine s.c. injection, HCL treatment 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
- Primary Outcome Measures
Name Time Method Determination of the rate of complete remissions after one cycle with subcutaneous cladribine 4 months after treatment
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (28)
Rhön-Saale-Klinik gGmbH
🇩🇪Bad Neustadt An Der Saale, Germany
Klinik Duisburg-West
🇩🇪Duisburg, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
University Clinic | Medicinal Clinic IV
🇩🇪Gießen, Germany
Städtisches Klinikum
🇩🇪Karlsruhe, Germany
St. Marienkrankenhaus
🇩🇪Ludwigshafen, Germany
St. Martinus-Hospital
🇩🇪Olpe, Germany
St. Josefs-Krankenhaus
🇩🇪Potsdam, Germany
University Clinic Ulm
🇩🇪Ulm, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Community based hemato-oncology medical office
🇩🇪Wolfsburg, Germany
Universitätsklinik Düsseldorf
🇩🇪Düsseldorf, Germany
Evangelisches Krankenhaus
🇩🇪Hamm, Germany
Marienkrankenhaus
🇩🇪Herne, Germany
St.-Marien-Hospital
🇩🇪Hagen, Germany
Klinikum Kempten-Oberallgäu
🇩🇪Kempten, Germany
Klinikum Leverkusen GmbH
🇩🇪Leverkusen, Germany
Universitätsklinik Mainz
🇩🇪Mainz, Germany
St. Clemens Hospital
🇩🇪Oberhausen, Germany
University Clinic Großhadern
🇩🇪München, Germany
Diakonie - Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Caritas Klinik St. Theresia
🇩🇪Saarbrücken, Germany
Kreiskrankenhaus Schotten
🇩🇪Schotten, Germany
St.-Marien-Krankenhaus
🇩🇪Siegen, Germany
Städtisches Krankenhaus Villingen
🇩🇪Villingen-Schwenningen, Germany
Asklepios Nordseeklinik
🇩🇪Westerland, Germany
Sophien- und Hufeland Klinikum
🇩🇪Weimar, Germany