Therapy Optimisation for the Treatment of Hairy Cell Leukemia

NCT02131753 | Recruiting Phase 2

• 1 other identifier: NHL 3-2004
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 76

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.

Conditions

Hairy Cell Leukemia

Keywords

hairy cell leukemia; untreated; cladribine subcutaneous

Outcome Measures

Primary Outcomes (1)

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

  4 months after treatment

Secondary Outcomes (1)

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

  4 months after treatment

Other Outcomes (4)

• Overall effectiveness

  20 years

• Improvement of remission deepness

  Date of staging after first cycle + 4 months

• Improvement of remission quality

  Date of staging after first cycle + 4 months

Study Arms (1)

Cladribine s.c. injection, HCL treatment

OTHER

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

Interventions

Cladribine s.c. injection, HCL treatment DRUG

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

Also known as: Litak(R), 2-CdA

Cladribine s.c. injection, HCL treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (76)

Community based hemato-oncology medical office

Ansbach, 91522, Germany

RECRUITING

Community based hemato-oncology medical office

Aschaffenburg, 63739, Germany

RECRUITING

Rhön-Saale-Klinik gGmbH

Bad Neustadt an der Saale, 97616, Germany

RECRUITING

Community based hemato-oncology medical office

Berlin, 10407, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

Community based hemato-oncology medical office

Bremen, 28209, Germany

RECRUITING

Community based hemato-oncology medical office

Celle, 29221, Germany

RECRUITING

Community based hemato-oncology medical office

Cottbus, 03046, Germany

RECRUITING

Community based hemato-oncology medical office

Darmstadt, 64295, Germany

RECRUITING

Community based hemato-oncology medical office

Dresden, 01127, Germany

RECRUITING

Community based hemato-oncology medical office

Duisburg, 47166, Germany

RECRUITING

Klinik Duisburg-West

Duisburg, 47228, Germany

RECRUITING

Universitätsklinik Düsseldorf

Düsseldorf, 40255, Germany

RECRUITING

Community based hemato-oncology medical office

Ehingen, 89584, Germany

RECRUITING

Community based hemato-oncology medical office

Erlangen, 91052, Germany

RECRUITING

Community based hemato-oncology medical office

Frankfurt, 60389, Germany

RECRUITING

Krankenhaus Nordwest

Frankfurt, 60488, Germany

RECRUITING

Community based hemato-oncology medical office

Freiburg im Breisgau, 79106, Germany

RECRUITING

Community based hemato-oncology medical office

Friedrichshafen, 88045, Germany

RECRUITING

Community based hemato-oncology medical office

Fürth, 90766, Germany

RECRUITING

Community based hemato-oncology medical office

Germering, 82110, Germany

RECRUITING

Community based hemato-oncology medical office

Giessen, 35392, Germany

RECRUITING

University Clinic | Medicinal Clinic IV

Giessen, 35592, Germany

RECRUITING

St.-Marien-Hospital

Hagen, 58095, Germany

RECRUITING

Community based hemato-oncology medical office

Halle, 06110, Germany

RECRUITING

Evangelisches Krankenhaus

Hamm, 59063, Germany

RECRUITING

Community based hemato-oncology medical office

Hanau, 63450, Germany

RECRUITING

Community based hemato-oncology medical office

Heidelberg, 69115, Germany

RECRUITING

Community based hemato-oncology medical office

Herne, 44623, Germany

RECRUITING

Marienkrankenhaus

Herne, 44625, Germany

RECRUITING

Community based hemato-oncology medical office

Homberg (Ohm), 34576, Germany

RECRUITING

Community based hemato-oncology medical office

Kaiserslautern, 67655, Germany

RECRUITING

Städtisches Klinikum

Karlsruhe, 76137, Germany

RECRUITING

Community based hemato-oncology medical office

Kassel, 34117, Germany

RECRUITING

Klinikum Kempten-Oberallgäu

Kempten, 87439, Germany

RECRUITING

Community based hemato-oncology medical office

Koblenz, 56068, Germany

NOT YET RECRUITING

Community based hemato-oncology medical office

Krefeld, 47798, Germany

RECRUITING

Community based hemato-oncology medical office

Kronach, 96317, Germany

RECRUITING

Community based hemato-oncology medical office

Landau, 76829, Germany

RECRUITING

Community based hemato-oncology medical office

Landshut, 84028, Germany

RECRUITING

Community based hemato-oncology medical office

Landshut, 84034, Germany

RECRUITING

Klinikum Leverkusen GmbH

Leverkusen, 51375, Germany

RECRUITING

St. Marienkrankenhaus

Ludwigshafen, 67067, Germany

RECRUITING

Community based hemato-oncology medical office

Lüdenscheid, 58507, Germany

RECRUITING

Universitätsklinik Mainz

Mainz, 55131, Germany

RECRUITING

Community based hemato-oncology medical office

Marburg, 35037, Germany

RECRUITING

Community based hemato-oncology medical office

Mönchengladbach, 41239, Germany

RECRUITING

Community based hemato-oncology medical office

München, 80335, Germany

RECRUITING

University Clinic Großhadern

München, 81377, Germany

RECRUITING

Community based hemato-oncology medical office

Neumarkt, 92318, Germany

RECRUITING

Community based hemato-oncology medical office

Nuremberg, 90403, Germany

RECRUITING

Community based hemato-oncology medical office

Nuremberg, 90449, Germany

RECRUITING

St. Clemens Hospital

Oberhausen, 46145, Germany

RECRUITING

St. Martinus-Hospital

Olpe, 57462, Germany

RECRUITING

Community based hemato-oncology medical office

Osnabrück, 49074, Germany

RECRUITING

St. Josefs-Krankenhaus

Potsdam, 14471, Germany

RECRUITING

Community based hemato-oncology medical office

Rehling, 86508, Germany

RECRUITING

Community based hemato-oncology medical office

Rüsselsheim am Main, 65428, Germany

RECRUITING

Caritas Klinik St. Theresia

Saarbrücken, 66113, Germany

RECRUITING

Community based hemato-oncology medical office

Schkeuditz, 04435, Germany

RECRUITING

Kreiskrankenhaus Schotten

Schotten, 63679, Germany

RECRUITING

Community based hemato-oncology medical office

Schweinfurt, 97421, Germany

RECRUITING

Community based hemato-oncology medical office

Siegen, 57072, Germany

RECRUITING

St.-Marien-Krankenhaus

Siegen, 57072, Germany

RECRUITING

Diakonie - Klinikum Stuttgart

Stuttgart, 70176, Germany

RECRUITING

Community based hemato-oncology medical office

Trier, 54290, Germany

RECRUITING

Community based hemato-oncology medical office

Tübingen, 72072, Germany

RECRUITING

University Clinic Ulm

Ulm, 89081, Germany

RECRUITING

Städtisches Krankenhaus Villingen

Villingen-Schwenningen, 78050, Germany

RECRUITING

Community based hemato-oncology medical office

Weilheim, 82362, Germany

RECRUITING

Sophien- und Hufeland Klinikum

Weimar, 99425, Germany

RECRUITING

Asklepios Nordseeklinik

Westerland, 25980, Germany

RECRUITING

Community based hemato-oncology medical office

Wiesbaden, 65191, Germany

RECRUITING

Dr. Horst-Schmidt-Kliniken

Wiesbaden, 65199, Germany

RECRUITING

Community based hemato-oncology medical office

Wilhelmshaven, 26389, Germany

RECRUITING

Community based hemato-oncology medical office

Wolfsburg, 38440, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mathias J Rummel, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias J Rummel, Prof PhD

CONTACT

+4964198542; mathias.rummel@innere.med.uni-giessen.de

Juergen Barth

CONTACT

+4964198542; juergen.barth@innere.med.uni-giessen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of StiL Coordinating Center

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2004
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (76)