Therapy Optimisation for the Treatment of Hairy Cell Leukemia

May 9, 2023 updated by: Jurgen Barth, University of Giessen

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

Recruiting

Conditions

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

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 2-CdA
  • Litak(R)

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:

  • 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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mathias J Rummel, Prof. Dr., Justus-Liebig-University | University Hospital | Medicinal Clinic IV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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