- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131753
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Mathias J Rummel, Prof PhD
- Phone Number: 650 +4964198542
- Email: mathias.rummel@innere.med.uni-giessen.de
Study Contact Backup
- Name: Juergen Barth
- Phone Number: 603 +4964198542
- Email: juergen.barth@innere.med.uni-giessen.de
Study Locations
-
-
-
Ansbach, Germany, 91522
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Sebastian Müller, PhD
-
Principal Investigator:
- Sebastian Müller, PhD
-
Aschaffenburg, Germany, 63739
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Manfred Welslau, PhD
-
Principal Investigator:
- Manfred Welslau, PhD
-
Bad Neustadt An Der Saale, Germany, 97616
- Recruiting
- Rhön-Saale-Klinik gGmbH
-
Contact:
- Klaus Wutke, PhD
-
Principal Investigator:
- Klaus Wutke, PhD
-
Berlin, Germany, 12203
- Recruiting
- Charité - Universitätsmedizin Berlin
-
Contact:
- Eckhard Thiel, Prof PhD
-
Principal Investigator:
- Eckhard Thiel, Prof PhD
-
Berlin, Germany, 10407
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Herbert Lebahn, PhD
-
Principal Investigator:
- Herbert Lebahn, PhD
-
Bremen, Germany, 28209
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Karl Wietholt, PhD
-
Principal Investigator:
- Karl Wietholt, PhD
-
Celle, Germany, 29221
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Felix Marquard, PhD
-
Principal Investigator:
- Felix Marquard, PhD
-
Cottbus, Germany, 03046
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Ulrich von Grünhagen, PhD
-
Principal Investigator:
- Ulrich von Grünhagen, PhD
-
Darmstadt, Germany, 64295
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Georgi Kojouharoff, PhD
-
Principal Investigator:
- Georgi Kojouharoff, PhD
-
Dresden, Germany, 01127
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Steffen Dörfel, PhD
-
Principal Investigator:
- Steffen Dörfel, PhD
-
Duisburg, Germany, 47166
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Johannes Selbach, PhD
-
Principal Investigator:
- Johannes Selbach, PhD
-
Duisburg, Germany, 47228
- Recruiting
- Klinik Duisburg-West
-
Contact:
- Rüdiger Lang, PhD
-
Principal Investigator:
- Rüdiger Lang, PhD
-
Düsseldorf, Germany, 40255
- Recruiting
- Universitätsklinik Düsseldorf
-
Contact:
- Guido Kobbe, PhD
-
Principal Investigator:
- Guido Kobbe, PhD
-
Ehingen, Germany, 89584
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Martin Simon, PhD
-
Principal Investigator:
- Martin Simon, PhD
-
Erlangen, Germany, 91052
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Michael J Eckart, PhD
-
Principal Investigator:
- Michael J Eckart, PhD
-
Frankfurt, Germany, 60389
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Wolfgang U Knauf, Prof PhD
-
Principal Investigator:
- Wolfgang U Knauf, Prof PhD
-
Frankfurt, Germany, 60488
- Recruiting
- Krankenhaus Nordwest
-
Contact:
- Eckhart Weidmann, Prof PhD
-
Principal Investigator:
- Eckhart Weidmann, Prof PhD
-
Freiburg, Germany, 79106
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Matthias Zaiss, PhD
-
Principal Investigator:
- Matthias Zaiss, PhD
-
Friedrichshafen, Germany, 88045
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Helmut Oettle, PhD
-
Principal Investigator:
- Helmut Oettle, PhD
-
Fürth, Germany, 90766
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Harald Wagner, PhD
-
Principal Investigator:
- Harald Wagner, PhD
-
Germering, Germany, 82110
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Johann Mittermüller, PhD
-
Principal Investigator:
- Johann Mittermüller, PhD
-
Gießen, Germany, 35392
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Georg Ch Schließer, PhD
-
Principal Investigator:
- Georg Ch Schließer, PhD
-
Gießen, Germany, 35592
- Recruiting
- University Clinic | Medicinal Clinic IV
-
Contact:
- Juergen Barth
- Phone Number: 603 +4964198542
- Email: juergen.barth@innere.med.uni-giessen.de
-
Contact:
- Mathias J Rummel, Prof. Dr.
- Phone Number: 650 +4964198542
- Email: mathias.rummel@innere.med.uni-giessen.de
-
Principal Investigator:
- Mathias J Rummel, Prof. Dr.
-
Hagen, Germany, 58095
- Recruiting
- St.-Marien-Hospital
-
Contact:
- H W Lindemann, PhD
-
Principal Investigator:
- H W Lindemann, PhD
-
Halle, Germany, 06110
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Robert Rohrberg, PhD
-
Principal Investigator:
- Robert Rohrberg, PhD
-
Hamm, Germany, 59063
- Recruiting
- Evangelisches Krankenhaus
-
Contact:
- Jörg Schubert, Prof PhD
-
Principal Investigator:
- Jörg Schubert, Prof PhD
-
Hanau, Germany, 63450
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Gerd Lautenschläger, PhD
-
Principal Investigator:
- Gerd Lautenschläger, PhD
-
Heidelberg, Germany, 69115
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Stefan Fuxius, PhD
-
Principal Investigator:
- Stefan Fuxius, Phd
-
Herne, Germany, 44623
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Lars Hahn, PhD
-
Principal Investigator:
- Lars Hahn, PhD
-
Herne, Germany, 44625
- Recruiting
- Marienkrankenhaus
-
Contact:
- Dirk Strumberg, Prof PhD
-
Principal Investigator:
- Dirk Strumberg, Prof PhD
-
Homberg, Germany, 34576
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Wolfgang Weber, PhD
-
Principal Investigator:
- Wolfgang Weber, PhD
-
Kaiserslautern, Germany, 67655
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Manfred Reeb, PhD
-
Principal Investigator:
- Manfred Reeb, PhD
-
Karlsruhe, Germany, 76137
- Recruiting
- Städtisches Klinikum
-
Contact:
- Martin Bentz, Prof. PhD
-
Principal Investigator:
- Martin Bentz, Prof. PhD
-
Kassel, Germany, 34117
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Ulrike Söling, PhD
-
Principal Investigator:
- Ulrike Söling, PhD
-
Kempten, Germany, 87439
- Recruiting
- Klinikum Kempten-Oberallgau
-
Contact:
- Otto Prümmer, PhD
-
Principal Investigator:
- Otto Prümmer, PhD
-
Koblenz, Germany, 56068
- Not yet recruiting
- Community based hemato-oncology medical office
-
Contact:
- Rudolf Weide, Prof PhD
-
Principal Investigator:
- Rudolf Weide, Prof PhD
-
Krefeld, Germany, 47798
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Michael Neise, PhD
-
Principal Investigator:
- Michael Neise, PhD
-
Kronach, Germany, 96317
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Martina Stauch, PhD
-
Principal Investigator:
- Stauch Martina, PhD
-
Landau, Germany, 76829
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Eva Huntenburg, PhD
-
Principal Investigator:
- Eva Huntenburg, PhD
-
Landshut, Germany, 84028
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Ursula Vehling-Kaiser, PhD
-
Principal Investigator:
- Ursula Vehling-Kaiser, PhD
-
Landshut, Germany, 84034
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Barbara Kempf, PhD
-
Principal Investigator:
- Barbara Kempf, PhD
-
Leverkusen, Germany, 51375
- Recruiting
- Klinikum Leverkusen GmbH
-
Contact:
- Norbert Niederle, Prof PhD
-
Principal Investigator:
- Norbert Niederle, Prof PhD
-
Ludwigshafen, Germany, 67067
- Recruiting
- St. Marienkrankenhaus
-
Contact:
- H Weiss, Prof PhD
-
Principal Investigator:
- H Weiss, Prof PhD
-
Lüdenscheid, Germany, 58507
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Dietrich Kämpfe, PhD
-
Principal Investigator:
- Dietrich Kämpfe, PhD
-
Mainz, Germany, 55131
- Recruiting
- Universitatsklinik Mainz
-
Contact:
- Georg Heß, PhD
-
Principal Investigator:
- Georg Heß, PhD
-
Marburg, Germany, 35037
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Christina Balser, PhD
-
Principal Investigator:
- Christina Balser, PhD
-
Mönchengladbach, Germany, 41239
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Ulrich Grabenhorst, PhD
-
Principal Investigator:
- Ulrich Grabenhorst, PhD
-
München, Germany, 80335
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Peter Bojko, PhD
-
Principal Investigator:
- Peter Bojko, PhD
-
München, Germany, 81377
- Recruiting
- University Clinic Großhadern
-
Contact:
- Martin Dreyling, Prof PhD
-
Principal Investigator:
- Martin Dreyling, Prof PhD
-
Neumarkt, Germany, 92318
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Ekkehart Ladda, PhD
-
Principal Investigator:
- Ekkehart Ladda, PhD
-
Nürnberg, Germany, 90403
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Michael Schauer, PhD
-
Principal Investigator:
- Michael Schauer, PhD
-
Nürnberg, Germany, 90449
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Joachim Zimber, PhD
-
Principal Investigator:
- Joachim Zimber, PhD
-
Oberhausen, Germany, 46145
- Recruiting
- St. Clemens Hospital
-
Contact:
- Jutta Schneider, PhD
-
Principal Investigator:
- Jutta Schneider, PhD
-
Olpe, Germany, 57462
- Recruiting
- St. Martinus-Hospital
-
Contact:
- Clemens Müller-Naendrup, PhD
-
Principal Investigator:
- Clemens Müller-Naendrup, PhD
-
Osnabrück, Germany, 49074
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Gertrud Lenzen, PhD
-
Principal Investigator:
- Gertrud Lenzen, PhD
-
Potsdam, Germany, 14471
- Recruiting
- St. Josefs-Krankenhaus
-
Contact:
- Michael Göner, PhD
-
Principal Investigator:
- Michael Göner, PhD
-
Rehling, Germany, 86508
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Stephan Hochdörfer, PhD
-
Principal Investigator:
- Stephan Hochdörfer, PhD
-
Rüsselsheim, Germany, 65428
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Michael Baldus, Phd
-
Principal Investigator:
- Michael Baldus, Phd
-
Saarbrücken, Germany, 66113
- Recruiting
- Caritas Klinik St. Theresia
-
Contact:
- Axel Matzdorff, Prof PhD
-
Principal Investigator:
- Axel Matzdorff, Prof PhD
-
Schkeuditz, Germany, 04435
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Thomas Edelmann, PhD
-
Principal Investigator:
- Thomas Edelmann, PhD
-
Schotten, Germany, 63679
- Recruiting
- Kreiskrankenhaus Schotten
-
Contact:
- M Graubner, PhD
-
Principal Investigator:
- M Graubner, PhD
-
Schweinfurt, Germany, 97421
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Reginhard von Hirschhausen, PhD
-
Principal Investigator:
- Reginhard von Hirschhausen, PhD
-
Siegen, Germany, 57072
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- F A Trux, PhD
-
Principal Investigator:
- F A Trux, PhD
-
Siegen, Germany, 57072
- Recruiting
- St.-Marien-Krankenhaus
-
Contact:
- Winfried Gassmann, PhD
-
Principal Investigator:
- Winfried Gassmann, PhD
-
Stuttgart, Germany, 70176
- Recruiting
- Diakonie - Klinikum Stuttgart
-
Contact:
- Else Heidemann, Prof PhD
-
Principal Investigator:
- Else Heidemann, Prof. PhD
-
Trier, Germany, 54290
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Hans P Laubenstein, PhD
-
Principal Investigator:
- Hans P Laubenstein, PhD
-
Tübingen, Germany, 72072
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Swen H Jacki, PhD
-
Principal Investigator:
- Swen H Jacki, PhD
-
Ulm, Germany, 89081
- Recruiting
- University Clinic Ulm
-
Contact:
- Christian Buske, Prof PhD
-
Principal Investigator:
- Christian Buske, Prof PhD
-
Villingen-Schwenningen, Germany, 78050
- Recruiting
- Städtisches Krankenhaus Villingen
-
Contact:
- Wolfram Brugger, Prof PhD
-
Principal Investigator:
- Wolfram Brugger, Prof. PhD
-
Weilheim, Germany, 82362
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Michael Sandherr, PhD
-
Principal Investigator:
- Michael Sandherr, PhD
-
Weimar, Germany, 99425
- Recruiting
- Sophien- und Hufeland Klinikum
-
Contact:
- Thomas Hoffmann, Phd
-
Principal Investigator:
- Thomas Hoffmann, PhD
-
Westerland, Germany, 25980
- Recruiting
- Asklepios Nordseeklinik
-
Contact:
- Willy Nettekoven, PhD
-
Principal Investigator:
- Willy Nettekoven, PhD
-
Wiesbaden, Germany, 65191
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Klaus M Josten, PhD
-
Principal Investigator:
- Klaus M Josten, PhD
-
Wiesbaden, Germany, 65199
- Recruiting
- Dr. Horst-Schmidt-Kliniken
-
Contact:
- Norbert Frickhofen, Prof PhD
-
Principal Investigator:
- Norbert Frickhofen, Prof PhD
-
Wilhelmshaven, Germany, 26389
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Yolanda Rodemer, PhD
-
Principal Investigator:
- Yolanda Rodemer, PhD
-
Wolfsburg, Germany, 38440
- Recruiting
- Community based hemato-oncology medical office
-
Contact:
- Joachim Haessner, PhD
-
Principal Investigator:
- Joachim Haessner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
Time Frame: 4 months after treatment
|
4 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of complete remissions in patient who still have detectable residual disease
Time Frame: 4 months after treatment
|
A second cycle of cladribine after an interval of 4 months following the first cycle.
|
4 months after treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall effectiveness
Time Frame: 20 years
|
Determination of:
|
20 years
|
Improvement of remission deepness
Time Frame: Date of staging after first cycle + 4 months
|
Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?
|
Date of staging after first cycle + 4 months
|
Improvement of remission quality
Time Frame: Date of staging after first cycle + 4 months
|
Can the quality of remission achieved with the first cycle be improved with a second cycle?
|
Date of staging after first cycle + 4 months
|
Lowering risk of relapse
Time Frame: Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 years
|
Can the expected risk of relapse be lowered and the duration of remission be prolonged?
|
Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathias J Rummel, Prof. Dr., Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHL 3-2004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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