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Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Primary Purpose

Hairy Cell Leukemia

Status

Recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cladribine s.c. injection, HCL treatment

About this trial

This is an interventional treatment trial for Hairy Cell Leukemia focused on measuring hairy cell leukemia, untreated, cladribine subcutaneous

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cladribine s.c. injection, HCL treatment

Arm 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

Outcomes

Primary Outcome Measures

Determination of the rate of complete remissions after one cycle with subcutaneous cladribine

Secondary Outcome Measures

Rate of complete remissions in patient who still have detectable residual disease

A second cycle of cladribine after an interval of 4 months following the first cycle.

Full Information

NCT ID

NCT02131753

First Posted

April 30, 2014

Last Updated

May 9, 2023

Sponsor

University of Giessen

1. Study Identification

Unique Protocol Identification Number

NCT02131753

Brief Title

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Official Title

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2004 (undefined)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Giessen

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hairy Cell Leukemia

Keywords

hairy cell leukemia, untreated, cladribine subcutaneous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cladribine s.c. injection, HCL treatment

Arm Type

Other

Arm 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

Intervention Type

Drug

Intervention Name(s)

Cladribine s.c. injection, HCL treatment

Other Intervention Name(s)

Litak(R), 2-CdA

Intervention 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

Primary Outcome Measure Information:

Title

Determination of the rate of complete remissions after one cycle with subcutaneous cladribine

Time Frame

4 months after treatment

Secondary Outcome Measure Information:

Title

Rate of complete remissions in patient who still have detectable residual disease

Description

A second cycle of cladribine after an interval of 4 months following the first cycle.

Time Frame

4 months after treatment

Other Pre-specified Outcome Measures:

Title

Overall effectiveness

Description

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

Time Frame

20 years

Title

Improvement of remission deepness

Description

Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?

Time Frame

Date of staging after first cycle + 4 months

Title

Improvement of remission quality

Description

Can the quality of remission achieved with the first cycle be improved with a second cycle?

Time Frame

Date of staging after first cycle + 4 months

Title

Lowering risk of relapse

Description

Can the expected risk of relapse be lowered and the duration of remission be prolonged?

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mathias J Rummel, Prof PhD

Phone

+4964198542

Ext

650

mathias.rummel@innere.med.uni-giessen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Juergen Barth

Phone

+4964198542

Ext

603

juergen.barth@innere.med.uni-giessen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias J Rummel, Prof. Dr.

Organizational Affiliation

Justus-Liebig-University | University Hospital | Medicinal Clinic IV

Official's Role

Principal Investigator

Facility Information:

Facility Name

Community based hemato-oncology medical office

City

Ansbach

ZIP/Postal Code

91522

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastian Müller, PhD

First Name & Middle Initial & Last Name & Degree

Sebastian Müller, PhD

Facility Name

Community based hemato-oncology medical office

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manfred Welslau, PhD

First Name & Middle Initial & Last Name & Degree

Manfred Welslau, PhD

Facility Name

Rhön-Saale-Klinik gGmbH

City

Bad Neustadt An Der Saale

ZIP/Postal Code

97616

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klaus Wutke, PhD

First Name & Middle Initial & Last Name & Degree

Klaus Wutke, PhD

Facility Name

Community based hemato-oncology medical office

City

Berlin

ZIP/Postal Code

10407

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herbert Lebahn, PhD

First Name & Middle Initial & Last Name & Degree

Herbert Lebahn, PhD

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eckhard Thiel, Prof PhD

First Name & Middle Initial & Last Name & Degree

Eckhard Thiel, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Bremen

ZIP/Postal Code

28209

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karl Wietholt, PhD

First Name & Middle Initial & Last Name & Degree

Karl Wietholt, PhD

Facility Name

Community based hemato-oncology medical office

City

Celle

ZIP/Postal Code

29221

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felix Marquard, PhD

First Name & Middle Initial & Last Name & Degree

Felix Marquard, PhD

Facility Name

Community based hemato-oncology medical office

City

Cottbus

ZIP/Postal Code

03046

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrich von Grünhagen, PhD

First Name & Middle Initial & Last Name & Degree

Ulrich von Grünhagen, PhD

Facility Name

Community based hemato-oncology medical office

City

Darmstadt

ZIP/Postal Code

64295

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georgi Kojouharoff, PhD

First Name & Middle Initial & Last Name & Degree

Georgi Kojouharoff, PhD

Facility Name

Community based hemato-oncology medical office

City

Dresden

ZIP/Postal Code

01127

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steffen Dörfel, PhD

First Name & Middle Initial & Last Name & Degree

Steffen Dörfel, PhD

Facility Name

Community based hemato-oncology medical office

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johannes Selbach, PhD

First Name & Middle Initial & Last Name & Degree

Johannes Selbach, PhD

Facility Name

Klinik Duisburg-West

City

Duisburg

ZIP/Postal Code

47228

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rüdiger Lang, PhD

First Name & Middle Initial & Last Name & Degree

Rüdiger Lang, PhD

Facility Name

Universitätsklinik Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40255

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guido Kobbe, PhD

First Name & Middle Initial & Last Name & Degree

Guido Kobbe, PhD

Facility Name

Community based hemato-oncology medical office

City

Ehingen

ZIP/Postal Code

89584

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Simon, PhD

First Name & Middle Initial & Last Name & Degree

Martin Simon, PhD

Facility Name

Community based hemato-oncology medical office

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael J Eckart, PhD

First Name & Middle Initial & Last Name & Degree

Michael J Eckart, PhD

Facility Name

Community based hemato-oncology medical office

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolfgang U Knauf, Prof PhD

First Name & Middle Initial & Last Name & Degree

Wolfgang U Knauf, Prof PhD

Facility Name

Krankenhaus Nordwest

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eckhart Weidmann, Prof PhD

First Name & Middle Initial & Last Name & Degree

Eckhart Weidmann, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Zaiss, PhD

First Name & Middle Initial & Last Name & Degree

Matthias Zaiss, PhD

Facility Name

Community based hemato-oncology medical office

City

Friedrichshafen

ZIP/Postal Code

88045

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helmut Oettle, PhD

First Name & Middle Initial & Last Name & Degree

Helmut Oettle, PhD

Facility Name

Community based hemato-oncology medical office

City

Fürth

ZIP/Postal Code

90766

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harald Wagner, PhD

First Name & Middle Initial & Last Name & Degree

Harald Wagner, PhD

Facility Name

Community based hemato-oncology medical office

City

Germering

ZIP/Postal Code

82110

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johann Mittermüller, PhD

First Name & Middle Initial & Last Name & Degree

Johann Mittermüller, PhD

Facility Name

Community based hemato-oncology medical office

City

Gießen

ZIP/Postal Code

35392

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georg Ch Schließer, PhD

First Name & Middle Initial & Last Name & Degree

Georg Ch Schließer, PhD

Facility Name

University Clinic | Medicinal Clinic IV

City

Gießen

ZIP/Postal Code

35592

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathias J Rummel, Prof. Dr.

Phone

+4964198542

Ext

650

mathias.rummel@innere.med.uni-giessen.de

First Name & Middle Initial & Last Name & Degree

Juergen Barth

Phone

+4964198542

Ext

603

juergen.barth@innere.med.uni-giessen.de

First Name & Middle Initial & Last Name & Degree

Mathias J Rummel, Prof. Dr.

Facility Name

St.-Marien-Hospital

City

Hagen

ZIP/Postal Code

58095

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

H W Lindemann, PhD

First Name & Middle Initial & Last Name & Degree

H W Lindemann, PhD

Facility Name

Community based hemato-oncology medical office

City

Halle

ZIP/Postal Code

06110

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Rohrberg, PhD

First Name & Middle Initial & Last Name & Degree

Robert Rohrberg, PhD

Facility Name

Evangelisches Krankenhaus

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jörg Schubert, Prof PhD

First Name & Middle Initial & Last Name & Degree

Jörg Schubert, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerd Lautenschläger, PhD

First Name & Middle Initial & Last Name & Degree

Gerd Lautenschläger, PhD

Facility Name

Community based hemato-oncology medical office

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Fuxius, PhD

First Name & Middle Initial & Last Name & Degree

Stefan Fuxius, Phd

Facility Name

Community based hemato-oncology medical office

City

Herne

ZIP/Postal Code

44623

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars Hahn, PhD

First Name & Middle Initial & Last Name & Degree

Lars Hahn, PhD

Facility Name

Marienkrankenhaus

City

Herne

ZIP/Postal Code

44625

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dirk Strumberg, Prof PhD

First Name & Middle Initial & Last Name & Degree

Dirk Strumberg, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Homberg

ZIP/Postal Code

34576

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolfgang Weber, PhD

First Name & Middle Initial & Last Name & Degree

Wolfgang Weber, PhD

Facility Name

Community based hemato-oncology medical office

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manfred Reeb, PhD

First Name & Middle Initial & Last Name & Degree

Manfred Reeb, PhD

Facility Name

Städtisches Klinikum

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Bentz, Prof. PhD

First Name & Middle Initial & Last Name & Degree

Martin Bentz, Prof. PhD

Facility Name

Community based hemato-oncology medical office

City

Kassel

ZIP/Postal Code

34117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrike Söling, PhD

First Name & Middle Initial & Last Name & Degree

Ulrike Söling, PhD

Facility Name

Klinikum Kempten-Oberallgäu

City

Kempten

ZIP/Postal Code

87439

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Otto Prümmer, PhD

First Name & Middle Initial & Last Name & Degree

Otto Prümmer, PhD

Facility Name

Community based hemato-oncology medical office

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rudolf Weide, Prof PhD

First Name & Middle Initial & Last Name & Degree

Rudolf Weide, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Krefeld

ZIP/Postal Code

47798

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Neise, PhD

First Name & Middle Initial & Last Name & Degree

Michael Neise, PhD

Facility Name

Community based hemato-oncology medical office

City

Kronach

ZIP/Postal Code

96317

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martina Stauch, PhD

First Name & Middle Initial & Last Name & Degree

Stauch Martina, PhD

Facility Name

Community based hemato-oncology medical office

City

Landau

ZIP/Postal Code

76829

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eva Huntenburg, PhD

First Name & Middle Initial & Last Name & Degree

Eva Huntenburg, PhD

Facility Name

Community based hemato-oncology medical office

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ursula Vehling-Kaiser, PhD

First Name & Middle Initial & Last Name & Degree

Ursula Vehling-Kaiser, PhD

Facility Name

Community based hemato-oncology medical office

City

Landshut

ZIP/Postal Code

84034

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara Kempf, PhD

First Name & Middle Initial & Last Name & Degree

Barbara Kempf, PhD

Facility Name

Klinikum Leverkusen GmbH

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert Niederle, Prof PhD

First Name & Middle Initial & Last Name & Degree

Norbert Niederle, Prof PhD

Facility Name

St. Marienkrankenhaus

City

Ludwigshafen

ZIP/Postal Code

67067

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

H Weiss, Prof PhD

First Name & Middle Initial & Last Name & Degree

H Weiss, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Lüdenscheid

ZIP/Postal Code

58507

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dietrich Kämpfe, PhD

First Name & Middle Initial & Last Name & Degree

Dietrich Kämpfe, PhD

Facility Name

Universitätsklinik Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georg Heß, PhD

First Name & Middle Initial & Last Name & Degree

Georg Heß, PhD

Facility Name

Community based hemato-oncology medical office

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina Balser, PhD

First Name & Middle Initial & Last Name & Degree

Christina Balser, PhD

Facility Name

Community based hemato-oncology medical office

City

Mönchengladbach

ZIP/Postal Code

41239

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrich Grabenhorst, PhD

First Name & Middle Initial & Last Name & Degree

Ulrich Grabenhorst, PhD

Facility Name

Community based hemato-oncology medical office

City

München

ZIP/Postal Code

80335

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Bojko, PhD

First Name & Middle Initial & Last Name & Degree

Peter Bojko, PhD

Facility Name

University Clinic Großhadern

City

München

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Dreyling, Prof PhD

First Name & Middle Initial & Last Name & Degree

Martin Dreyling, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Neumarkt

ZIP/Postal Code

92318

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ekkehart Ladda, PhD

First Name & Middle Initial & Last Name & Degree

Ekkehart Ladda, PhD

Facility Name

Community based hemato-oncology medical office

City

Nürnberg

ZIP/Postal Code

90403

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Schauer, PhD

First Name & Middle Initial & Last Name & Degree

Michael Schauer, PhD

Facility Name

Community based hemato-oncology medical office

City

Nürnberg

ZIP/Postal Code

90449

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joachim Zimber, PhD

First Name & Middle Initial & Last Name & Degree

Joachim Zimber, PhD

Facility Name

St. Clemens Hospital

City

Oberhausen

ZIP/Postal Code

46145

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jutta Schneider, PhD

First Name & Middle Initial & Last Name & Degree

Jutta Schneider, PhD

Facility Name

St. Martinus-Hospital

City

Olpe

ZIP/Postal Code

57462

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clemens Müller-Naendrup, PhD

First Name & Middle Initial & Last Name & Degree

Clemens Müller-Naendrup, PhD

Facility Name

Community based hemato-oncology medical office

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gertrud Lenzen, PhD

First Name & Middle Initial & Last Name & Degree

Gertrud Lenzen, PhD

Facility Name

St. Josefs-Krankenhaus

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Göner, PhD

First Name & Middle Initial & Last Name & Degree

Michael Göner, PhD

Facility Name

Community based hemato-oncology medical office

City

Rehling

ZIP/Postal Code

86508

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Hochdörfer, PhD

First Name & Middle Initial & Last Name & Degree

Stephan Hochdörfer, PhD

Facility Name

Community based hemato-oncology medical office

City

Rüsselsheim

ZIP/Postal Code

65428

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Baldus, Phd

First Name & Middle Initial & Last Name & Degree

Michael Baldus, Phd

Facility Name

Caritas Klinik St. Theresia

City

Saarbrücken

ZIP/Postal Code

66113

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Axel Matzdorff, Prof PhD

First Name & Middle Initial & Last Name & Degree

Axel Matzdorff, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Schkeuditz

ZIP/Postal Code

04435

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Edelmann, PhD

First Name & Middle Initial & Last Name & Degree

Thomas Edelmann, PhD

Facility Name

Kreiskrankenhaus Schotten

City

Schotten

ZIP/Postal Code

63679

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M Graubner, PhD

First Name & Middle Initial & Last Name & Degree

M Graubner, PhD

Facility Name

Community based hemato-oncology medical office

City

Schweinfurt

ZIP/Postal Code

97421

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reginhard von Hirschhausen, PhD

First Name & Middle Initial & Last Name & Degree

Reginhard von Hirschhausen, PhD

Facility Name

Community based hemato-oncology medical office

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

F A Trux, PhD

First Name & Middle Initial & Last Name & Degree

F A Trux, PhD

Facility Name

St.-Marien-Krankenhaus

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Winfried Gassmann, PhD

First Name & Middle Initial & Last Name & Degree

Winfried Gassmann, PhD

Facility Name

Diakonie - Klinikum Stuttgart

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Else Heidemann, Prof PhD

First Name & Middle Initial & Last Name & Degree

Else Heidemann, Prof. PhD

Facility Name

Community based hemato-oncology medical office

City

Trier

ZIP/Postal Code

54290

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hans P Laubenstein, PhD

First Name & Middle Initial & Last Name & Degree

Hans P Laubenstein, PhD

Facility Name

Community based hemato-oncology medical office

City

Tübingen

ZIP/Postal Code

72072

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Swen H Jacki, PhD

First Name & Middle Initial & Last Name & Degree

Swen H Jacki, PhD

Facility Name

University Clinic Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Buske, Prof PhD

First Name & Middle Initial & Last Name & Degree

Christian Buske, Prof PhD

Facility Name

Städtisches Krankenhaus Villingen

City

Villingen-Schwenningen

ZIP/Postal Code

78050

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolfram Brugger, Prof PhD

First Name & Middle Initial & Last Name & Degree

Wolfram Brugger, Prof. PhD

Facility Name

Community based hemato-oncology medical office

City

Weilheim

ZIP/Postal Code

82362

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Sandherr, PhD

First Name & Middle Initial & Last Name & Degree

Michael Sandherr, PhD

Facility Name

Sophien- und Hufeland Klinikum

City

Weimar

ZIP/Postal Code

99425

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Hoffmann, Phd

First Name & Middle Initial & Last Name & Degree

Thomas Hoffmann, PhD

Facility Name

Asklepios Nordseeklinik

City

Westerland

ZIP/Postal Code

25980

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Willy Nettekoven, PhD

First Name & Middle Initial & Last Name & Degree

Willy Nettekoven, PhD

Facility Name

Community based hemato-oncology medical office

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klaus M Josten, PhD

First Name & Middle Initial & Last Name & Degree

Klaus M Josten, PhD

Facility Name

Dr. Horst-Schmidt-Kliniken

City

Wiesbaden

ZIP/Postal Code

65199

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert Frickhofen, Prof PhD

First Name & Middle Initial & Last Name & Degree

Norbert Frickhofen, Prof PhD

Facility Name

Community based hemato-oncology medical office

City

Wilhelmshaven

ZIP/Postal Code

26389

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yolanda Rodemer, PhD

First Name & Middle Initial & Last Name & Degree

Yolanda Rodemer, PhD

Facility Name

Community based hemato-oncology medical office

City

Wolfsburg

ZIP/Postal Code

38440

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joachim Haessner, PhD

First Name & Middle Initial & Last Name & Degree

Joachim Haessner, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

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Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Hairy Cell Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial