Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Sponsors

Lead Sponsor: University of Giessen

Source 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.

Overall Status Recruiting
Start Date 2004-05-01
Completion Date 2027-12-01
Primary Completion Date 2022-12-01
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine 4 months after treatment
Secondary Outcome
Measure Time Frame
Rate of complete remissions in patient who still have detectable residual disease 4 months after treatment
Enrollment 210
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cladribine s.c. injection, HCL treatment

Description: 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

Arm Group Label: Cladribine s.c. injection, HCL treatment

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Mathias J Rummel, Prof. Dr. Principal Investigator Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Overall Contact

Last Name: Mathias J Rummel, Prof PhD

Phone: +4964198542

Phone Ext.: 650

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Community based hemato-oncology medical office | Ansbach, 91522, Germany Recruiting Sebastian Müller, PhD Sebastian Müller, PhD Principal Investigator
Community based hemato-oncology medical office | Aschaffenburg, 63739, Germany Recruiting Manfred Welslau, PhD Manfred Welslau, PhD Principal Investigator
Rhön-Saale-Klinik gGmbH | Bad Neustadt An Der Saale, 97616, Germany Recruiting Klaus Wutke, PhD Klaus Wutke, PhD Principal Investigator
Community based hemato-oncology medical office | Berlin, 10407, Germany Recruiting Herbert Lebahn, PhD Herbert Lebahn, PhD Principal Investigator
Charité - Universitätsmedizin Berlin | Berlin, 12203, Germany Recruiting Eckhard Thiel, Prof PhD Eckhard Thiel, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Bremen, 28209, Germany Recruiting Karl Wietholt, PhD Karl Wietholt, PhD Principal Investigator
Community based hemato-oncology medical office | Celle, 29221, Germany Recruiting Felix Marquard, PhD Felix Marquard, PhD Principal Investigator
Community based hemato-oncology medical office | Cottbus, 03046, Germany Recruiting Ulrich von Grünhagen, PhD Ulrich von Grünhagen, PhD Principal Investigator
Community based hemato-oncology medical office | Darmstadt, 64295, Germany Recruiting Georgi Kojouharoff, PhD Georgi Kojouharoff, PhD Principal Investigator
Community based hemato-oncology medical office | Dresden, 01127, Germany Recruiting Steffen Dörfel, PhD Steffen Dörfel, PhD Principal Investigator
Community based hemato-oncology medical office | Duisburg, 47166, Germany Recruiting Johannes Selbach, PhD Johannes Selbach, PhD Principal Investigator
Klinik Duisburg-West | Duisburg, 47228, Germany Recruiting Rüdiger Lang, PhD Rüdiger Lang, PhD Principal Investigator
Universitätsklinik Düsseldorf | Düsseldorf, 40255, Germany Recruiting Guido Kobbe, PhD Guido Kobbe, PhD Principal Investigator
Community based hemato-oncology medical office | Ehingen, 89584, Germany Recruiting Martin Simon, PhD Martin Simon, PhD Principal Investigator
Community based hemato-oncology medical office | Erlangen, 91052, Germany Recruiting Michael J Eckart, PhD Michael J Eckart, PhD Principal Investigator
Community based hemato-oncology medical office | Frankfurt, 60389, Germany Recruiting Wolfgang U Knauf, Prof PhD Wolfgang U Knauf, Prof PhD Principal Investigator
Krankenhaus Nordwest | Frankfurt, 60488, Germany Recruiting Eckhart Weidmann, Prof PhD Eckhart Weidmann, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Freiburg, 79106, Germany Recruiting Matthias Zaiss, PhD Matthias Zaiss, PhD Principal Investigator
Community based hemato-oncology medical office | Friedrichshafen, 88045, Germany Recruiting Helmut Oettle, PhD Helmut Oettle, PhD Principal Investigator
Community based hemato-oncology medical office | Fürth, 90766, Germany Recruiting Harald Wagner, PhD Harald Wagner, PhD Principal Investigator
Community based hemato-oncology medical office | Germering, 82110, Germany Recruiting Johann Mittermüller, PhD Johann Mittermüller, PhD Principal Investigator
Community based hemato-oncology medical office | Gießen, 35392, Germany Recruiting Georg Ch Schließer, PhD Georg Ch Schließer, PhD Principal Investigator
University Clinic | Medicinal Clinic IV | Gießen, 35592, Germany Recruiting Mathias J Rummel, Prof. Dr. +4964198542 650 [email protected] Mathias J Rummel, Prof. Dr. Principal Investigator
St.-Marien-Hospital | Hagen, 58095, Germany Recruiting H W Lindemann, PhD H W Lindemann, PhD Principal Investigator
Community based hemato-oncology medical office | Halle, 06110, Germany Recruiting Robert Rohrberg, PhD Robert Rohrberg, PhD Principal Investigator
Evangelisches Krankenhaus | Hamm, 59063, Germany Recruiting Jörg Schubert, Prof PhD Jörg Schubert, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Hanau, 63450, Germany Recruiting Gerd Lautenschläger, PhD Gerd Lautenschläger, PhD Principal Investigator
Community based hemato-oncology medical office | Heidelberg, 69115, Germany Recruiting Stefan Fuxius, PhD Stefan Fuxius, Phd Principal Investigator
Community based hemato-oncology medical office | Herne, 44623, Germany Recruiting Lars Hahn, PhD Lars Hahn, PhD Principal Investigator
Marienkrankenhaus | Herne, 44625, Germany Recruiting Dirk Strumberg, Prof PhD Dirk Strumberg, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Homberg, 34576, Germany Recruiting Wolfgang Weber, PhD Wolfgang Weber, PhD Principal Investigator
Community based hemato-oncology medical office | Kaiserslautern, 67655, Germany Recruiting Manfred Reeb, PhD Manfred Reeb, PhD Principal Investigator
Städtisches Klinikum | Karlsruhe, 76137, Germany Recruiting Martin Bentz, Prof. PhD Martin Bentz, Prof. PhD Principal Investigator
Community based hemato-oncology medical office | Kassel, 34117, Germany Recruiting Ulrike Söling, PhD Ulrike Söling, PhD Principal Investigator
Klinikum Kempten-Oberallgäu | Kempten, 87439, Germany Recruiting Otto Prümmer, PhD Otto Prümmer, PhD Principal Investigator
Community based hemato-oncology medical office | Koblenz, 56068, Germany Not yet recruiting Rudolf Weide, Prof PhD Rudolf Weide, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Krefeld, 47798, Germany Recruiting Michael Neise, PhD Michael Neise, PhD Principal Investigator
Community based hemato-oncology medical office | Kronach, 96317, Germany Recruiting Martina Stauch, PhD Stauch Martina, PhD Principal Investigator
Community based hemato-oncology medical office | Landau, 76829, Germany Recruiting Eva Huntenburg, PhD Eva Huntenburg, PhD Principal Investigator
Community based hemato-oncology medical office | Landshut, 84028, Germany Recruiting Ursula Vehling-Kaiser, PhD Ursula Vehling-Kaiser, PhD Principal Investigator
Community based hemato-oncology medical office | Landshut, 84034, Germany Recruiting Barbara Kempf, PhD Barbara Kempf, PhD Principal Investigator
Klinikum Leverkusen GmbH | Leverkusen, 51375, Germany Recruiting Norbert Niederle, Prof PhD Norbert Niederle, Prof PhD Principal Investigator
St. Marienkrankenhaus | Ludwigshafen, 67067, Germany Recruiting H Weiss, Prof PhD H Weiss, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Lüdenscheid, 58507, Germany Recruiting Dietrich Kämpfe, PhD Dietrich Kämpfe, PhD Principal Investigator
Universitätsklinik Mainz | Mainz, 55131, Germany Recruiting Georg Heß, PhD Georg Heß, PhD Principal Investigator
Community based hemato-oncology medical office | Marburg, 35037, Germany Recruiting Christina Balser, PhD Christina Balser, PhD Principal Investigator
Community based hemato-oncology medical office | Mönchengladbach, 41239, Germany Recruiting Ulrich Grabenhorst, PhD Ulrich Grabenhorst, PhD Principal Investigator
Community based hemato-oncology medical office | München, 80335, Germany Recruiting Peter Bojko, PhD Peter Bojko, PhD Principal Investigator
University Clinic Großhadern | München, 81377, Germany Recruiting Martin Dreyling, Prof PhD Martin Dreyling, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Neumarkt, 92318, Germany Recruiting Ekkehart Ladda, PhD Ekkehart Ladda, PhD Principal Investigator
Community based hemato-oncology medical office | Nürnberg, 90403, Germany Recruiting Michael Schauer, PhD Michael Schauer, PhD Principal Investigator
Community based hemato-oncology medical office | Nürnberg, 90449, Germany Recruiting Joachim Zimber, PhD Joachim Zimber, PhD Principal Investigator
St. Clemens Hospital | Oberhausen, 46145, Germany Recruiting Jutta Schneider, PhD Jutta Schneider, PhD Principal Investigator
St. Martinus-Hospital | Olpe, 57462, Germany Recruiting Clemens Müller-Naendrup, PhD Clemens Müller-Naendrup, PhD Principal Investigator
Community based hemato-oncology medical office | Osnabrück, 49074, Germany Recruiting Gertrud Lenzen, PhD Gertrud Lenzen, PhD Principal Investigator
St. Josefs-Krankenhaus | Potsdam, 14471, Germany Recruiting Michael Göner, PhD Michael Göner, PhD Principal Investigator
Community based hemato-oncology medical office | Rehling, 86508, Germany Recruiting Stephan Hochdörfer, PhD Stephan Hochdörfer, PhD Principal Investigator
Community based hemato-oncology medical office | Rüsselsheim, 65428, Germany Recruiting Michael Baldus, Phd Michael Baldus, Phd Principal Investigator
Caritas Klinik St. Theresia | Saarbrücken, 66113, Germany Recruiting Axel Matzdorff, Prof PhD Axel Matzdorff, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Schkeuditz, 04435, Germany Recruiting Thomas Edelmann, PhD Thomas Edelmann, PhD Principal Investigator
Kreiskrankenhaus Schotten | Schotten, 63679, Germany Recruiting M Graubner, PhD M Graubner, PhD Principal Investigator
Community based hemato-oncology medical office | Schweinfurt, 97421, Germany Recruiting Reginhard von Hirschhausen, PhD Reginhard von Hirschhausen, PhD Principal Investigator
Community based hemato-oncology medical office | Siegen, 57072, Germany Recruiting F A Trux, PhD F A Trux, PhD Principal Investigator
St.-Marien-Krankenhaus | Siegen, 57072, Germany Recruiting Winfried Gassmann, PhD Winfried Gassmann, PhD Principal Investigator
Diakonie - Klinikum Stuttgart | Stuttgart, 70176, Germany Recruiting Else Heidemann, Prof PhD Else Heidemann, Prof. PhD Principal Investigator
Community based hemato-oncology medical office | Trier, 54290, Germany Recruiting Hans P Laubenstein, PhD Hans P Laubenstein, PhD Principal Investigator
Community based hemato-oncology medical office | Tübingen, 72072, Germany Recruiting Swen H Jacki, PhD Swen H Jacki, PhD Principal Investigator
University Clinic Ulm | Ulm, 89081, Germany Recruiting Christian Buske, Prof PhD Christian Buske, Prof PhD Principal Investigator
Städtisches Krankenhaus Villingen | Villingen-Schwenningen, 78050, Germany Recruiting Wolfram Brugger, Prof PhD Wolfram Brugger, Prof. PhD Principal Investigator
Community based hemato-oncology medical office | Weilheim, 82362, Germany Recruiting Michael Sandherr, PhD Michael Sandherr, PhD Principal Investigator
Sophien- und Hufeland Klinikum | Weimar, 99425, Germany Recruiting Thomas Hoffmann, Phd Thomas Hoffmann, PhD Principal Investigator
Asklepios Nordseeklinik | Westerland, 25980, Germany Recruiting Willy Nettekoven, PhD Willy Nettekoven, PhD Principal Investigator
Community based hemato-oncology medical office | Wiesbaden, 65191, Germany Recruiting Klaus M Josten, PhD Klaus M Josten, PhD Principal Investigator
Dr. Horst-Schmidt-Kliniken | Wiesbaden, 65199, Germany Recruiting Norbert Frickhofen, Prof PhD Norbert Frickhofen, Prof PhD Principal Investigator
Community based hemato-oncology medical office | Wilhelmshaven, 26389, Germany Recruiting Yolanda Rodemer, PhD Yolanda Rodemer, PhD Principal Investigator
Community based hemato-oncology medical office | Wolfsburg, 38440, Germany Recruiting Joachim Haessner, PhD Joachim Haessner, PhD Principal Investigator
Location Countries

Germany

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Giessen

Investigator Full Name: Jurgen Barth

Investigator Title: Head of StiL Coordinating Center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cladribine s.c. injection, HCL treatment

Type: Other

Description: 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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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