ClinicalTrials.gov
History of Changes for Study: NCT02131753
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Latest version (submitted May 9, 2023) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 2, 2014 None (earliest Version on record)
2 June 17, 2015 Study Status
3 October 25, 2016 Study Status and IPDSharing
4 January 11, 2018 Study Status
5 April 18, 2019 Contacts/Locations and Study Status
6 November 11, 2020 Study Status
7 April 28, 2021 Study Status
8 May 17, 2022 Study Status
9 May 9, 2023 Study Status
Comparison Format:
Scroll up to access the controls
Study NCT02131753
Submitted Date:  May 2, 2014 (v1)
Open or close this module Study Identification
Unique Protocol ID: NHL 3-2004
Brief Title: Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Official Title: Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2014
Overall Status: Recruiting
Study Start: May 2004
Primary Completion: December 2015 [Anticipated]
Study Completion: December 2025 [Anticipated]
First Submitted: April 30, 2014
First Submitted that
Met QC Criteria:		 May 2, 2014
First Posted: May 6, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 2, 2014
Last Update Posted: May 6, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Giessen
Responsible Party: Principal Investigator
Investigator: Jurgen Barth
Official Title: Head of StiL Coordinating Center
Affiliation: University of Giessen
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Hairy Cell Leukemia
Keywords: hairy cell leukemia
untreated
cladribine subcutaneous
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 210 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
 Drug: 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 Names:
  • Litak(R)
  • 2-CdA
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
[ Time Frame: 4 months after treatment ]
Secondary Outcome Measures:
1. 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.
Other Outcome Measures:
1. Overall effectiveness
[ Time Frame: 20 years ]

Determination of:

  • overall remission rate
  • duration of remission
  • immunodeficiency induced by treatment, its duration, infectious and other complications resulting from that
  • frequency of secondary neoplasia during life long follow up
  • overall survival
2. 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?
3. 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?
4. 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?
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Mathias J Rummel, Prof PhD
Telephone: +4964198542 Ext. 650
Email: mathias.rummel@innere.med.uni-giessen.de
Central Contact Backup: Juergen Barth
Telephone: +4964198542 Ext. 603
Email: juergen.barth@innere.med.uni-giessen.de
Study Officials: Mathias J Rummel, Prof. Dr.
Principal Investigator
Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Locations: Germany
Community based hemato-oncology medical office
[Recruiting]
Ansbach, Germany, 91522
Contact:Contact: Sebastian Müller, PhD
Contact:Principal Investigator: Sebastian Müller, PhD
Community based hemato-oncology medical office
[Recruiting]
Aschaffenburg, Germany, 63739
Contact:Contact: Manfred Welslau, PhD
Contact:Principal Investigator: Manfred Welslau, PhD
Rhön-Saale-Klinik gGmbH
[Recruiting]
Bad Neustadt, Germany, 97616
Contact:Contact: Klaus Wutke, PhD
Contact:Principal Investigator: Klaus Wutke, PhD
Community based hemato-oncology medical office
[Recruiting]
Berlin, Germany, 10407
Contact:Contact: Herbert Lebahn, PhD
Contact:Principal Investigator: Herbert Lebahn, PhD
Charité - Universitätsmedizin Berlin
[Recruiting]
Berlin, Germany, 12203
Contact:Contact: Eckhard Thiel, Prof PhD
Contact:Principal Investigator: Eckhard Thiel, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Bremen, Germany, 28209
Contact:Contact: Karl Wietholt, PhD
Contact:Principal Investigator: Karl Wietholt, PhD
Community based hemato-oncology medical office
[Recruiting]
Celle, Germany, 29221
Contact:Contact: Felix Marquard, PhD
Contact:Principal Investigator: Felix Marquard, PhD
Community based hemato-oncology medical office
[Recruiting]
Cottbus, Germany, 03046
Contact:Contact: Ulrich von Grünhagen, PhD
Contact:Principal Investigator: Ulrich von Grünhagen, PhD
Community based hemato-oncology medical office
[Recruiting]
Darmstadt, Germany, 64295
Contact:Contact: Georgi Kojouharoff, PhD
Contact:Principal Investigator: Georgi Kojouharoff, PhD
Community based hemato-oncology medical office
[Recruiting]
Dresden, Germany, 01127
Contact:Contact: Steffen Dörfel, PhD
Contact:Principal Investigator: Steffen Dörfel, PhD
Community based hemato-oncology medical office
[Recruiting]
Duisburg, Germany, 47166
Contact:Contact: Johannes Selbach, PhD
Contact:Principal Investigator: Johannes Selbach, PhD
Klinik Duisburg-West
[Recruiting]
Duisburg, Germany, 47228
Contact:Contact: Rüdiger Lang, PhD
Contact:Principal Investigator: Rüdiger Lang, PhD
Universitätsklinik Düsseldorf
[Recruiting]
Düsseldorf, Germany, 40255
Contact:Contact: Guido Kobbe, PhD
Contact:Principal Investigator: Guido Kobbe, PhD
Community based hemato-oncology medical office
[Recruiting]
Ehingen, Germany, 89584
Contact:Contact: Martin Simon, PhD
Contact:Principal Investigator: Martin Simon, PhD
Community based hemato-oncology medical office
[Recruiting]
Erlangen, Germany, 91052
Contact:Contact: Michael J Eckart, PhD
Contact:Principal Investigator: Michael J Eckart, PhD
Community based hemato-oncology medical office
[Recruiting]
Frankfurt, Germany, 60389
Contact:Contact: Wolfgang U Knauf, Prof PhD
Contact:Principal Investigator: Wolfgang U Knauf, Prof PhD
Krankenhaus Nordwest
[Recruiting]
Frankfurt, Germany, 60488
Contact:Contact: Eckhart Weidmann, Prof PhD
Contact:Principal Investigator: Eckhart Weidmann, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Freiburg, Germany, 79106
Contact:Contact: Matthias Zaiss, PhD
Contact:Principal Investigator: Matthias Zaiss, PhD
Community based hemato-oncology medical office
[Recruiting]
Friedrichshafen, Germany, 88045
Contact:Contact: Helmut Oettle, PhD
Contact:Principal Investigator: Helmut Oettle, PhD
Community based hemato-oncology medical office
[Recruiting]
Fürth, Germany, 90766
Contact:Contact: Harald Wagner, PhD
Contact:Principal Investigator: Harald Wagner, PhD
Community based hemato-oncology medical office
[Recruiting]
Germering, Germany, 82110
Contact:Contact: Johann Mittermüller, PhD
Contact:Principal Investigator: Johann Mittermüller, PhD
Community based hemato-oncology medical office
[Recruiting]
Gießen, Germany, 35392
Contact:Contact: Georg Ch Schließer, PhD
Contact:Principal Investigator: Georg Ch Schließer, PhD
University Clinic | Medicinal Clinic IV
[Recruiting]
Gießen, Germany, 35592
Contact:Contact: Mathias J Rummel, Prof. Dr. +4964198542 Ext. 650 mathias.rummel@innere.med.uni-giessen.de
Contact:Contact: Juergen Barth +4964198542 Ext. 603 juergen.barth@innere.med.uni-giessen.de
Contact:Principal Investigator: Mathias J Rummel, Prof. Dr.
St.-Marien-Hospital
[Recruiting]
Hagen, Germany, 58095
Contact:Contact: H W Lindemann, PhD
Contact:Principal Investigator: H W Lindemann, PhD
Community based hemato-oncology medical office
[Recruiting]
Halle, Germany, 06110
Contact:Contact: Robert Rohrberg, PhD
Contact:Principal Investigator: Robert Rohrberg, PhD
Evangelisches Krankenhaus
[Recruiting]
Hamm, Germany, 59063
Contact:Contact: Jörg Schubert, Prof PhD
Contact:Principal Investigator: Jörg Schubert, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Hanau, Germany, 63450
Contact:Contact: Gerd Lautenschläger, PhD
Contact:Principal Investigator: Gerd Lautenschläger, PhD
Community based hemato-oncology medical office
[Recruiting]
Heidelberg, Germany, 69115
Contact:Contact: Stefan Fuxius, PhD
Contact:Principal Investigator: Stefan Fuxius, Phd
Community based hemato-oncology medical office
[Recruiting]
Herne, Germany, 44623
Contact:Contact: Lars Hahn, PhD
Contact:Principal Investigator: Lars Hahn, PhD
Marienkrankenhaus
[Recruiting]
Herne, Germany, 44625
Contact:Contact: Dirk Strumberg, Prof PhD
Contact:Principal Investigator: Dirk Strumberg, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Homberg / Efze, Germany, 34626
Contact:Contact: Wolfgang Weber, PhD
Contact:Principal Investigator: Wolfgang Weber, PhD
Community based hemato-oncology medical office
[Recruiting]
Kaiserslautern, Germany, 67655
Contact:Contact: Manfred Reeb, PhD
Contact:Principal Investigator: Manfred Reeb, PhD
Städtisches Klinikum
[Recruiting]
Karlsruhe, Germany, 76137
Contact:Contact: Martin Bentz, Prof. PhD
Contact:Principal Investigator: Martin Bentz, Prof. PhD
Community based hemato-oncology medical office
[Recruiting]
Kassel, Germany, 34117
Contact:Contact: Ulrike Söling, PhD
Contact:Principal Investigator: Ulrike Söling, PhD
Klinikum Kempten-Oberallgäu
[Recruiting]
Kempten, Germany, 87439
Contact:Contact: Otto Prümmer, PhD
Contact:Principal Investigator: Otto Prümmer, PhD
Community based hemato-oncology medical office
[Not yet recruiting]
Koblenz, Germany, 56068
Contact:Contact: Rudolf Weide, Prof PhD
Contact:Principal Investigator: Rudolf Weide, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Krefeld, Germany, 47798
Contact:Contact: Michael Neise, PhD
Contact:Principal Investigator: Michael Neise, PhD
Community based hemato-oncology medical office
[Recruiting]
Kronach, Germany, 96317
Contact:Contact: Martina Stauch, PhD
Contact:Principal Investigator: Stauch Martina, PhD
Community based hemato-oncology medical office
[Recruiting]
Landau, Germany, 76829
Contact:Contact: Eva Huntenburg, PhD
Contact:Principal Investigator: Eva Huntenburg, PhD
Community based hemato-oncology medical office
[Recruiting]
Landshut, Germany, 84028
Contact:Contact: Ursula Vehling-Kaiser, PhD
Contact:Principal Investigator: Ursula Vehling-Kaiser, PhD
Community based hemato-oncology medical office
[Recruiting]
Landshut, Germany, 84034
Contact:Contact: Barbara Kempf, PhD
Contact:Principal Investigator: Barbara Kempf, PhD
Klinikum Leverkusen GmbH
[Recruiting]
Leverkusen, Germany, 51375
Contact:Contact: Norbert Niederle, Prof PhD
Contact:Principal Investigator: Norbert Niederle, Prof PhD
St. Marienkrankenhaus
[Recruiting]
Ludwigshafen, Germany, 67067
Contact:Contact: H Weiss, Prof PhD
Contact:Principal Investigator: H Weiss, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Lüdenscheid, Germany, 58507
Contact:Contact: Dietrich Kämpfe, PhD
Contact:Principal Investigator: Dietrich Kämpfe, PhD
Universitätsklinik Mainz
[Recruiting]
Mainz, Germany, 55131
Contact:Contact: Georg Heß, PhD
Contact:Principal Investigator: Georg Heß, PhD
Community based hemato-oncology medical office
[Recruiting]
Marburg, Germany, 35037
Contact:Contact: Christina Balser, PhD
Contact:Principal Investigator: Christina Balser, PhD
Community based hemato-oncology medical office
[Recruiting]
Mönchengladbach, Germany, 41239
Contact:Contact: Ulrich Grabenhorst, PhD
Contact:Principal Investigator: Ulrich Grabenhorst, PhD
Community based hemato-oncology medical office
[Recruiting]
München, Germany, 80335
Contact:Contact: Peter Bojko, PhD
Contact:Principal Investigator: Peter Bojko, PhD
University Clinic Großhadern
[Recruiting]
München, Germany, 81377
Contact:Contact: Martin Dreyling, Prof PhD
Contact:Principal Investigator: Martin Dreyling, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Neumarkt, Germany, 92318
Contact:Contact: Ekkehart Ladda, PhD
Contact:Principal Investigator: Ekkehart Ladda, PhD
Community based hemato-oncology medical office
[Recruiting]
Nürnberg, Germany, 90403
Contact:Contact: Michael Schauer, PhD
Contact:Principal Investigator: Michael Schauer, PhD
Community based hemato-oncology medical office
[Recruiting]
Nürnberg, Germany, 90449
Contact:Contact: Joachim Zimber, PhD
Contact:Principal Investigator: Joachim Zimber, PhD
St. Clemens Hospital
[Recruiting]
Oberhausen, Germany, 46145
Contact:Contact: Jutta Schneider, PhD
Contact:Principal Investigator: Jutta Schneider, PhD
St. Martinus-Hospital
[Recruiting]
Olpe, Germany, 57462
Contact:Contact: Clemens Müller-Naendrup, PhD
Contact:Principal Investigator: Clemens Müller-Naendrup, PhD
Community based hemato-oncology medical office
[Recruiting]
Osnabrück, Germany, 49074
Contact:Contact: Gertrud Lenzen, PhD
Contact:Principal Investigator: Gertrud Lenzen, PhD
St. Josefs-Krankenhaus
[Recruiting]
Potsdam, Germany, 14471
Contact:Contact: Michael Göner, PhD
Contact:Principal Investigator: Michael Göner, PhD
Community based hemato-oncology medical office
[Recruiting]
Rehling, Germany, 86508
Contact:Contact: Stephan Hochdörfer, PhD
Contact:Principal Investigator: Stephan Hochdörfer, PhD
Community based hemato-oncology medical office
[Recruiting]
Rüsselsheim, Germany, 65428
Contact:Contact: Michael Baldus, Phd
Contact:Principal Investigator: Michael Baldus, Phd
Caritas Klinik St. Theresia
[Recruiting]
Saarbrücken, Germany, 66113
Contact:Contact: Axel Matzdorff, Prof PhD
Contact:Principal Investigator: Axel Matzdorff, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Schkeuditz, Germany, 04435
Contact:Contact: Thomas Edelmann, PhD
Contact:Principal Investigator: Thomas Edelmann, PhD
Kreiskrankenhaus Schotten
[Recruiting]
Schotten, Germany, 63679
Contact:Contact: M Graubner, PhD
Contact:Principal Investigator: M Graubner, PhD
Community based hemato-oncology medical office
[Recruiting]
Schweinfurt, Germany, 97421
Contact:Contact: Reginhard von Hirschhausen, PhD
Contact:Principal Investigator: Reginhard von Hirschhausen, PhD
Community based hemato-oncology medical office
[Recruiting]
Siegen, Germany, 57072
Contact:Contact: F A Trux, PhD
Contact:Principal Investigator: F A Trux, PhD
St.-Marien-Krankenhaus
[Recruiting]
Siegen, Germany, 57072
Contact:Contact: Winfried Gassmann, PhD
Contact:Principal Investigator: Winfried Gassmann, PhD
Diakonie - Klinikum Stuttgart
[Recruiting]
Stuttgart, Germany, 70176
Contact:Contact: Else Heidemann, Prof PhD
Contact:Principal Investigator: Else Heidemann, Prof. PhD
Community based hemato-oncology medical office
[Recruiting]
Trier, Germany, 54290
Contact:Contact: Hans P Laubenstein, PhD
Contact:Principal Investigator: Hans P Laubenstein, PhD
Community based hemato-oncology medical office
[Recruiting]
Tübingen, Germany, 72072
Contact:Contact: Swen H Jacki, PhD
Contact:Principal Investigator: Swen H Jacki, PhD
University Clinic Ulm
[Recruiting]
Ulm, Germany, 89081
Contact:Contact: Christian Buske, Prof PhD
Contact:Principal Investigator: Christian Buske, Prof PhD
Städtisches Krankenhaus Villingen
[Recruiting]
Villingen-Schwenningen, Germany, 78050
Contact:Contact: Wolfram Brugger, Prof PhD
Contact:Principal Investigator: Wolfram Brugger, Prof. PhD
Community based hemato-oncology medical office
[Recruiting]
Weilheim, Germany, 82362
Contact:Contact: Michael Sandherr, PhD
Contact:Principal Investigator: Michael Sandherr, PhD
Sophien- und Hufeland Klinikum
[Recruiting]
Weimar, Germany, 99425
Contact:Contact: Thomas Hoffmann, Phd
Contact:Principal Investigator: Thomas Hoffmann, PhD
Asklepios Nordseeklinik
[Recruiting]
Westerland, Germany, 25980
Contact:Contact: Willy Nettekoven, PhD
Contact:Principal Investigator: Willy Nettekoven, PhD
Community based hemato-oncology medical office
[Recruiting]
Wiesbaden, Germany, 65191
Contact:Contact: Klaus M Josten, PhD
Contact:Principal Investigator: Klaus M Josten, PhD
Dr. Horst-Schmidt-Kliniken
[Recruiting]
Wiesbaden, Germany, 65199
Contact:Contact: Norbert Frickhofen, Prof PhD
Contact:Principal Investigator: Norbert Frickhofen, Prof PhD
Community based hemato-oncology medical office
[Recruiting]
Wilhelmshaven, Germany, 26389
Contact:Contact: Yolanda Rodemer, PhD
Contact:Principal Investigator: Yolanda Rodemer, PhD
Community based hemato-oncology medical office
[Recruiting]
Wolfsburg, Germany, 38440
Contact:Contact: Joachim Haessner, PhD
Contact:Principal Investigator: Joachim Haessner, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services