Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Conditions
Hairy Cell Leukemia
Conditions: official terms
Leukemia - Leukemia, Hairy Cell
Conditions: Keywords
hairy cell leukemia, untreated, cladribine subcutaneous
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cladribine s.c. injection, HCL treatment
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Community based hemato-oncology medical office
Ansbach, Germany
Status: Recruiting
Contact: Sebastian Müller, PhD
Community based hemato-oncology medical office
Aschaffenburg, Germany
Status: Recruiting
Contact: Manfred Welslau, PhD
Rhön-Saale-Klinik gGmbH
Bad Neustadt, Germany
Status: Recruiting
Contact: Klaus Wutke, PhD
Charité - Universitätsmedizin Berlin
Berlin, Germany
Status: Recruiting
Contact: Eckhard Thiel, Prof PhD
Community based hemato-oncology medical office
Berlin, Germany
Status: Recruiting
Contact: Herbert Lebahn, PhD
Community based hemato-oncology medical office
Bremen, Germany
Status: Recruiting
Contact: Karl Wietholt, PhD
Community based hemato-oncology medical office
Celle, Germany
Status: Recruiting
Contact: Felix Marquard, PhD
Community based hemato-oncology medical office
Cottbus, Germany
Status: Recruiting
Contact: Ulrich von Grünhagen, PhD
Community based hemato-oncology medical office
Darmstadt, Germany
Status: Recruiting
Contact: Georgi Kojouharoff, PhD
Community based hemato-oncology medical office
Dresden, Germany
Status: Recruiting
Contact: Steffen Dörfel, PhD
Community based hemato-oncology medical office
Duisburg, Germany
Status: Recruiting
Contact: Johannes Selbach, PhD
Klinik Duisburg-West
Duisburg, Germany
Status: Recruiting
Contact: Rüdiger Lang, PhD
Universitätsklinik Düsseldorf
Düsseldorf, Germany
Status: Recruiting
Contact: Guido Kobbe, PhD
Community based hemato-oncology medical office
Ehingen, Germany
Status: Recruiting
Contact: Martin Simon, PhD
Community based hemato-oncology medical office
Erlangen, Germany
Status: Recruiting
Contact: Michael J Eckart, PhD
Community based hemato-oncology medical office
Frankfurt, Germany
Status: Recruiting
Contact: Wolfgang U Knauf, Prof PhD
Krankenhaus Nordwest
Frankfurt, Germany
Status: Recruiting
Contact: Eckhart Weidmann, Prof PhD
Community based hemato-oncology medical office
Freiburg, Germany
Status: Recruiting
Contact: Matthias Zaiss, PhD
Community based hemato-oncology medical office
Friedrichshafen, Germany
Status: Recruiting
Contact: Helmut Oettle, PhD
Community based hemato-oncology medical office
Fürth, Germany
Status: Recruiting
Contact: Harald Wagner, PhD
Community based hemato-oncology medical office
Germering, Germany
Status: Recruiting
Contact: Johann Mittermüller, PhD
Community based hemato-oncology medical office
Gießen, Germany
Status: Recruiting
Contact: Georg Ch Schließer, PhD
University Clinic | Medicinal Clinic IV
Gießen, Germany
Status: Recruiting
Contact: Mathias J Rummel, Prof. Dr. - +4964198542 - mathias.rummel@innere.med.uni-giessen.de
St.-Marien-Hospital
Hagen, Germany
Status: Recruiting
Contact: H W Lindemann, PhD
Community based hemato-oncology medical office
Halle, Germany
Status: Recruiting
Contact: Robert Rohrberg, PhD
Evangelisches Krankenhaus
Hamm, Germany
Status: Recruiting
Contact: Jörg Schubert, Prof PhD
Community based hemato-oncology medical office
Hanau, Germany
Status: Recruiting
Contact: Gerd Lautenschläger, PhD
Community based hemato-oncology medical office
Heidelberg, Germany
Status: Recruiting
Contact: Stefan Fuxius, PhD
Community based hemato-oncology medical office
Herne, Germany
Status: Recruiting
Contact: Lars Hahn, PhD
Marienkrankenhaus
Herne, Germany
Status: Recruiting
Contact: Dirk Strumberg, Prof PhD
Community based hemato-oncology medical office
Homberg / Efze, Germany
Status: Recruiting
Contact: Wolfgang Weber, PhD
Community based hemato-oncology medical office
Kaiserslautern, Germany
Status: Recruiting
Contact: Manfred Reeb, PhD
Städtisches Klinikum
Karlsruhe, Germany
Status: Recruiting
Contact: Martin Bentz, Prof. PhD
Community based hemato-oncology medical office
Kassel, Germany
Status: Recruiting
Contact: Ulrike Söling, PhD
Klinikum Kempten-Oberallgäu
Kempten, Germany
Status: Recruiting
Contact: Otto Prümmer, PhD
Community based hemato-oncology medical office
Koblenz, Germany
Status: Not yet recruiting
Contact: Rudolf Weide, Prof PhD
Community based hemato-oncology medical office
Krefeld, Germany
Status: Recruiting
Contact: Michael Neise, PhD
Community based hemato-oncology medical office
Kronach, Germany
Status: Recruiting
Contact: Martina Stauch, PhD
Community based hemato-oncology medical office
Landau, Germany
Status: Recruiting
Contact: Eva Huntenburg, PhD
Community based hemato-oncology medical office
Landshut, Germany
Status: Recruiting
Contact: Ursula Vehling-Kaiser, PhD
Community based hemato-oncology medical office
Landshut, Germany
Status: Recruiting
Contact: Barbara Kempf, PhD
Klinikum Leverkusen GmbH
Leverkusen, Germany
Status: Recruiting
Contact: Norbert Niederle, Prof PhD
St. Marienkrankenhaus
Ludwigshafen, Germany
Status: Recruiting
Contact: H Weiss, Prof PhD
Community based hemato-oncology medical office
Lüdenscheid, Germany
Status: Recruiting
Contact: Dietrich Kämpfe, PhD
Universitätsklinik Mainz
Mainz, Germany
Status: Recruiting
Contact: Georg Heß, PhD
Community based hemato-oncology medical office
Marburg, Germany
Status: Recruiting
Contact: Christina Balser, PhD
Community based hemato-oncology medical office
Mönchengladbach, Germany
Status: Recruiting
Contact: Ulrich Grabenhorst, PhD
Community based hemato-oncology medical office
München, Germany
Status: Recruiting
Contact: Peter Bojko, PhD
University Clinic Großhadern
München, Germany
Status: Recruiting
Contact: Martin Dreyling, Prof PhD
Community based hemato-oncology medical office
Neumarkt, Germany
Status: Recruiting
Contact: Ekkehart Ladda, PhD
Community based hemato-oncology medical office
Nürnberg, Germany
Status: Recruiting
Contact: Michael Schauer, PhD
Community based hemato-oncology medical office
Nürnberg, Germany
Status: Recruiting
Contact: Joachim Zimber, PhD
St. Clemens Hospital
Oberhausen, Germany
Status: Recruiting
Contact: Jutta Schneider, PhD
St. Martinus-Hospital
Olpe, Germany
Status: Recruiting
Contact: Clemens Müller-Naendrup, PhD
Community based hemato-oncology medical office
Osnabrück, Germany
Status: Recruiting
Contact: Gertrud Lenzen, PhD
St. Josefs-Krankenhaus
Potsdam, Germany
Status: Recruiting
Contact: Michael Göner, PhD
Community based hemato-oncology medical office
Rehling, Germany
Status: Recruiting
Contact: Stephan Hochdörfer, PhD
Community based hemato-oncology medical office
Rüsselsheim, Germany
Status: Recruiting
Contact: Michael Baldus, Phd
Caritas Klinik St. Theresia
Saarbrücken, Germany
Status: Recruiting
Contact: Axel Matzdorff, Prof PhD
Community based hemato-oncology medical office
Schkeuditz, Germany
Status: Recruiting
Contact: Thomas Edelmann, PhD
Kreiskrankenhaus Schotten
Schotten, Germany
Status: Recruiting
Contact: M Graubner, PhD
Community based hemato-oncology medical office
Schweinfurt, Germany
Status: Recruiting
Contact: Reginhard von Hirschhausen, PhD
Community based hemato-oncology medical office
Siegen, Germany
Status: Recruiting
Contact: F A Trux, PhD
St.-Marien-Krankenhaus
Siegen, Germany
Status: Recruiting
Contact: Winfried Gassmann, PhD
Diakonie - Klinikum Stuttgart
Stuttgart, Germany
Status: Recruiting
Contact: Else Heidemann, Prof PhD
Community based hemato-oncology medical office
Trier, Germany
Status: Recruiting
Contact: Hans P Laubenstein, PhD
Community based hemato-oncology medical office
Tübingen, Germany
Status: Recruiting
Contact: Swen H Jacki, PhD
University Clinic Ulm
Ulm, Germany
Status: Recruiting
Contact: Christian Buske, Prof PhD
Städtisches Krankenhaus Villingen
Villingen-Schwenningen, Germany
Status: Recruiting
Contact: Wolfram Brugger, Prof PhD
Community based hemato-oncology medical office
Weilheim, Germany
Status: Recruiting
Contact: Michael Sandherr, PhD
Sophien- und Hufeland Klinikum
Weimar, Germany
Status: Recruiting
Contact: Thomas Hoffmann, Phd
Asklepios Nordseeklinik
Westerland, Germany
Status: Recruiting
Contact: Willy Nettekoven, PhD
Community based hemato-oncology medical office
Wiesbaden, Germany
Status: Recruiting
Contact: Klaus M Josten, PhD
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany
Status: Recruiting
Contact: Norbert Frickhofen, Prof PhD
Community based hemato-oncology medical office
Wilhelmshaven, Germany
Status: Recruiting
Contact: Yolanda Rodemer, PhD
Community based hemato-oncology medical office
Wolfsburg, Germany
Status: Recruiting
Contact: Joachim Haessner, PhD
Start Date
May 2004
Completion Date
December 2025
Sponsors
University of Giessen
Source
University of Giessen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page