Therapy Optimisation for the Treatment of Hairy Cell Leukemia
NCT ID: NCT02131753
Last Updated: 2024-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
210 participants
INTERVENTIONAL
2004-05-31
2027-12-31
Brief Summary
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They have to be untreated so far or may be pretreated with alpha-interferon.
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Detailed Description
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Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Cladribine 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
Interventions
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Cladribine 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Responsible Party
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Jurgen Barth
Head of StiL Coordinating Center
Principal Investigators
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Mathias J Rummel, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Locations
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Community based hemato-oncology medical office
Ansbach, , Germany
Community based hemato-oncology medical office
Aschaffenburg, , Germany
Rhön-Saale-Klinik gGmbH
Bad Neustadt an der Saale, , Germany
Community based hemato-oncology medical office
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Community based hemato-oncology medical office
Bremen, , Germany
Community based hemato-oncology medical office
Celle, , Germany
Community based hemato-oncology medical office
Cottbus, , Germany
Community based hemato-oncology medical office
Darmstadt, , Germany
Community based hemato-oncology medical office
Dresden, , Germany
Community based hemato-oncology medical office
Duisburg, , Germany
Klinik Duisburg-West
Duisburg, , Germany
Universitätsklinik Düsseldorf
Düsseldorf, , Germany
Community based hemato-oncology medical office
Ehingen, , Germany
Community based hemato-oncology medical office
Erlangen, , Germany
Community based hemato-oncology medical office
Frankfurt, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
Community based hemato-oncology medical office
Freiburg im Breisgau, , Germany
Community based hemato-oncology medical office
Friedrichshafen, , Germany
Community based hemato-oncology medical office
Fürth, , Germany
Community based hemato-oncology medical office
Germering, , Germany
Community based hemato-oncology medical office
Giessen, , Germany
University Clinic | Medicinal Clinic IV
Giessen, , Germany
St.-Marien-Hospital
Hagen, , Germany
Community based hemato-oncology medical office
Halle, , Germany
Evangelisches Krankenhaus
Hamm, , Germany
Community based hemato-oncology medical office
Hanau, , Germany
Community based hemato-oncology medical office
Heidelberg, , Germany
Community based hemato-oncology medical office
Herne, , Germany
Marienkrankenhaus
Herne, , Germany
Community based hemato-oncology medical office
Homberg (Ohm), , Germany
Community based hemato-oncology medical office
Kaiserslautern, , Germany
Städtisches Klinikum
Karlsruhe, , Germany
Community based hemato-oncology medical office
Kassel, , Germany
Klinikum Kempten-Oberallgäu
Kempten, , Germany
Community based hemato-oncology medical office
Koblenz, , Germany
Community based hemato-oncology medical office
Krefeld, , Germany
Community based hemato-oncology medical office
Kronach, , Germany
Community based hemato-oncology medical office
Landau, , Germany
Community based hemato-oncology medical office
Landshut, , Germany
Community based hemato-oncology medical office
Landshut, , Germany
Klinikum Leverkusen GmbH
Leverkusen, , Germany
St. Marienkrankenhaus
Ludwigshafen, , Germany
Community based hemato-oncology medical office
Lüdenscheid, , Germany
Universitätsklinik Mainz
Mainz, , Germany
Community based hemato-oncology medical office
Marburg, , Germany
Community based hemato-oncology medical office
Mönchengladbach, , Germany
Community based hemato-oncology medical office
München, , Germany
University Clinic Großhadern
München, , Germany
Community based hemato-oncology medical office
Neumarkt, , Germany
Community based hemato-oncology medical office
Nuremberg, , Germany
Community based hemato-oncology medical office
Nuremberg, , Germany
St. Clemens Hospital
Oberhausen, , Germany
St. Martinus-Hospital
Olpe, , Germany
Community based hemato-oncology medical office
Osnabrück, , Germany
St. Josefs-Krankenhaus
Potsdam, , Germany
Community based hemato-oncology medical office
Rehling, , Germany
Community based hemato-oncology medical office
Rüsselsheim am Main, , Germany
Caritas Klinik St. Theresia
Saarbrücken, , Germany
Community based hemato-oncology medical office
Schkeuditz, , Germany
Kreiskrankenhaus Schotten
Schotten, , Germany
Community based hemato-oncology medical office
Schweinfurt, , Germany
Community based hemato-oncology medical office
Siegen, , Germany
St.-Marien-Krankenhaus
Siegen, , Germany
Diakonie - Klinikum Stuttgart
Stuttgart, , Germany
Community based hemato-oncology medical office
Trier, , Germany
Community based hemato-oncology medical office
Tübingen, , Germany
University Clinic Ulm
Ulm, , Germany
Städtisches Krankenhaus Villingen
Villingen-Schwenningen, , Germany
Community based hemato-oncology medical office
Weilheim, , Germany
Sophien- und Hufeland Klinikum
Weimar, , Germany
Asklepios Nordseeklinik
Westerland, , Germany
Community based hemato-oncology medical office
Wiesbaden, , Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , Germany
Community based hemato-oncology medical office
Wilhelmshaven, , Germany
Community based hemato-oncology medical office
Wolfsburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Sebastian Müller, PhD
Role: primary
Manfred Welslau, PhD
Role: primary
Klaus Wutke, PhD
Role: primary
Herbert Lebahn, PhD
Role: primary
Eckhard Thiel, Prof PhD
Role: primary
Karl Wietholt, PhD
Role: primary
Felix Marquard, PhD
Role: primary
Ulrich von Grünhagen, PhD
Role: primary
Georgi Kojouharoff, PhD
Role: primary
Steffen Dörfel, PhD
Role: primary
Johannes Selbach, PhD
Role: primary
Rüdiger Lang, PhD
Role: primary
Guido Kobbe, PhD
Role: primary
Martin Simon, PhD
Role: primary
Michael J Eckart, PhD
Role: primary
Wolfgang U Knauf, Prof PhD
Role: primary
Eckhart Weidmann, Prof PhD
Role: primary
Matthias Zaiss, PhD
Role: primary
Helmut Oettle, PhD
Role: primary
Harald Wagner, PhD
Role: primary
Johann Mittermüller, PhD
Role: primary
Georg Ch Schließer, PhD
Role: primary
H W Lindemann, PhD
Role: primary
Robert Rohrberg, PhD
Role: primary
Jörg Schubert, Prof PhD
Role: primary
Gerd Lautenschläger, PhD
Role: primary
Stefan Fuxius, PhD
Role: primary
Lars Hahn, PhD
Role: primary
Dirk Strumberg, Prof PhD
Role: primary
Wolfgang Weber, PhD
Role: primary
Manfred Reeb, PhD
Role: primary
Martin Bentz, Prof. PhD
Role: primary
Ulrike Söling, PhD
Role: primary
Otto Prümmer, PhD
Role: primary
Rudolf Weide, Prof PhD
Role: primary
Michael Neise, PhD
Role: primary
Martina Stauch, PhD
Role: primary
Eva Huntenburg, PhD
Role: primary
Ursula Vehling-Kaiser, PhD
Role: primary
Barbara Kempf, PhD
Role: primary
Norbert Niederle, Prof PhD
Role: primary
H Weiss, Prof PhD
Role: primary
Dietrich Kämpfe, PhD
Role: primary
Georg Heß, PhD
Role: primary
Christina Balser, PhD
Role: primary
Ulrich Grabenhorst, PhD
Role: primary
Peter Bojko, PhD
Role: primary
Martin Dreyling, Prof PhD
Role: primary
Ekkehart Ladda, PhD
Role: primary
Michael Schauer, PhD
Role: primary
Joachim Zimber, PhD
Role: primary
Jutta Schneider, PhD
Role: primary
Clemens Müller-Naendrup, PhD
Role: primary
Gertrud Lenzen, PhD
Role: primary
Michael Göner, PhD
Role: primary
Stephan Hochdörfer, PhD
Role: primary
Michael Baldus, Phd
Role: primary
Axel Matzdorff, Prof PhD
Role: primary
Thomas Edelmann, PhD
Role: primary
M Graubner, PhD
Role: primary
Reginhard von Hirschhausen, PhD
Role: primary
F A Trux, PhD
Role: primary
Winfried Gassmann, PhD
Role: primary
Else Heidemann, Prof PhD
Role: primary
Hans P Laubenstein, PhD
Role: primary
Swen H Jacki, PhD
Role: primary
Christian Buske, Prof PhD
Role: primary
Wolfram Brugger, Prof PhD
Role: primary
Michael Sandherr, PhD
Role: primary
Thomas Hoffmann, Phd
Role: primary
Willy Nettekoven, PhD
Role: primary
Klaus M Josten, PhD
Role: primary
Norbert Frickhofen, Prof PhD
Role: primary
Yolanda Rodemer, PhD
Role: primary
Joachim Haessner, PhD
Role: primary
Other Identifiers
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NHL 3-2004
Identifier Type: -
Identifier Source: org_study_id
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