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Recruiting

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

NCT02131753 · University of Giessen
In plain English

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About this study
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.
Eligibility 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
Study design
Enrollment target: 210 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2004-05
Estimated completion: 2027-12
Last updated: 2024-08-22
Interventions
Drug: Cladribine s.c. injection, HCL treatment
Primary outcomes
  • Determination of the rate of complete remissions after one cycle with subcutaneous cladribine (4 months after treatment)
Sponsor
University of Giessen · other
Contacts & investigators
ContactMathias J Rummel, Prof PhD · contact · mathias.rummel@innere.med.uni-giessen.de · +4964198542
ContactJuergen Barth · contact · juergen.barth@innere.med.uni-giessen.de · +4964198542
InvestigatorMathias J Rummel, Prof. Dr. · principal_investigator, Justus-Liebig-University | University Hospital | Medicinal Clinic IV
All locations (76)
Community based hemato-oncology medical officeRecruiting
Ansbach, Germany
Community based hemato-oncology medical officeRecruiting
Aschaffenburg, Germany
Rhön-Saale-Klinik gGmbHRecruiting
Bad Neustadt an der Saale, Germany
Community based hemato-oncology medical officeRecruiting
Berlin, Germany
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany
Community based hemato-oncology medical officeRecruiting
Bremen, Germany
Community based hemato-oncology medical officeRecruiting
Celle, Germany
Community based hemato-oncology medical officeRecruiting
Cottbus, Germany
Community based hemato-oncology medical officeRecruiting
Darmstadt, Germany
Community based hemato-oncology medical officeRecruiting
Dresden, Germany
Community based hemato-oncology medical officeRecruiting
Duisburg, Germany
Klinik Duisburg-WestRecruiting
Duisburg, Germany
Universitätsklinik DüsseldorfRecruiting
Düsseldorf, Germany
Community based hemato-oncology medical officeRecruiting
Ehingen, Germany
Community based hemato-oncology medical officeRecruiting
Erlangen, Germany
Community based hemato-oncology medical officeRecruiting
Frankfurt, Germany
Krankenhaus NordwestRecruiting
Frankfurt, Germany
Community based hemato-oncology medical officeRecruiting
Freiburg im Breisgau, Germany
Community based hemato-oncology medical officeRecruiting
Friedrichshafen, Germany
Community based hemato-oncology medical officeRecruiting
Fürth, Germany
Community based hemato-oncology medical officeRecruiting
Germering, Germany
Community based hemato-oncology medical officeRecruiting
Giessen, Germany
University Clinic | Medicinal Clinic IVRecruiting
Giessen, Germany
St.-Marien-HospitalRecruiting
Hagen, Germany
Community based hemato-oncology medical officeRecruiting
Halle, Germany
Evangelisches KrankenhausRecruiting
Hamm, Germany
Community based hemato-oncology medical officeRecruiting
Hanau, Germany
Community based hemato-oncology medical officeRecruiting
Heidelberg, Germany
Community based hemato-oncology medical officeRecruiting
Herne, Germany
MarienkrankenhausRecruiting
Herne, Germany
Community based hemato-oncology medical officeRecruiting
Homberg (Ohm), Germany
Community based hemato-oncology medical officeRecruiting
Kaiserslautern, Germany
Städtisches KlinikumRecruiting
Karlsruhe, Germany
Community based hemato-oncology medical officeRecruiting
Kassel, Germany
Klinikum Kempten-OberallgäuRecruiting
Kempten, Germany
Community based hemato-oncology medical officeNot Yet Recruiting
Koblenz, Germany
Community based hemato-oncology medical officeRecruiting
Krefeld, Germany
Community based hemato-oncology medical officeRecruiting
Kronach, Germany
Community based hemato-oncology medical officeRecruiting
Landau, Germany
Community based hemato-oncology medical officeRecruiting
Landshut, Germany
Community based hemato-oncology medical officeRecruiting
Landshut, Germany
Klinikum Leverkusen GmbHRecruiting
Leverkusen, Germany
St. MarienkrankenhausRecruiting
Ludwigshafen, Germany
Community based hemato-oncology medical officeRecruiting
Lüdenscheid, Germany
Universitätsklinik MainzRecruiting
Mainz, Germany
Community based hemato-oncology medical officeRecruiting
Marburg, Germany
Community based hemato-oncology medical officeRecruiting
Mönchengladbach, Germany
Community based hemato-oncology medical officeRecruiting
München, Germany
University Clinic GroßhadernRecruiting
München, Germany
Community based hemato-oncology medical officeRecruiting
Neumarkt, Germany
Community based hemato-oncology medical officeRecruiting
Nuremberg, Germany
Community based hemato-oncology medical officeRecruiting
Nuremberg, Germany
St. Clemens HospitalRecruiting
Oberhausen, Germany
St. Martinus-HospitalRecruiting
Olpe, Germany
Community based hemato-oncology medical officeRecruiting
Osnabrück, Germany
St. Josefs-KrankenhausRecruiting
Potsdam, Germany
Community based hemato-oncology medical officeRecruiting
Rehling, Germany
Community based hemato-oncology medical officeRecruiting
Rüsselsheim am Main, Germany
Caritas Klinik St. TheresiaRecruiting
Saarbrücken, Germany
Community based hemato-oncology medical officeRecruiting
Schkeuditz, Germany
Kreiskrankenhaus SchottenRecruiting
Schotten, Germany
Community based hemato-oncology medical officeRecruiting
Schweinfurt, Germany
Community based hemato-oncology medical officeRecruiting
Siegen, Germany
St.-Marien-KrankenhausRecruiting
Siegen, Germany
Diakonie - Klinikum StuttgartRecruiting
Stuttgart, Germany
Community based hemato-oncology medical officeRecruiting
Trier, Germany
Community based hemato-oncology medical officeRecruiting
Tübingen, Germany
University Clinic UlmRecruiting
Ulm, Germany
Städtisches Krankenhaus VillingenRecruiting
Villingen-Schwenningen, Germany
Community based hemato-oncology medical officeRecruiting
Weilheim, Germany
Sophien- und Hufeland KlinikumRecruiting
Weimar, Germany
Asklepios NordseeklinikRecruiting
Westerland, Germany
Community based hemato-oncology medical officeRecruiting
Wiesbaden, Germany
Dr. Horst-Schmidt-KlinikenRecruiting
Wiesbaden, Germany
Community based hemato-oncology medical officeRecruiting
Wilhelmshaven, Germany
Community based hemato-oncology medical officeRecruiting
Wolfsburg, Germany
Therapy Optimisation for the Treatment of Hairy Cell Leukemia · TrialPath