Hairy Cell Leukemia (HCL) Clinical Trial
Official title:
Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
The study will test the effectiveness (rate of complete remissions, total remission rate and
duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous
cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for
relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous
therapy.
CD20* = cluster of differentiation antigen 20
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | January 2013 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or - Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin - Need for treatment is indicated (see 4.3 below) - Age at least 18 years - General state of health according to WHO 0-2 - Written declaration of consent by the patient - Current histology, which should not be older than 6 months, is necessary Exclusion Criteria: - Patients, who do not fulfil the above-mentioned inclusion criteria. - Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min - Patients with proven HIV infections - Patients with active hepatitis - Patients with other florid infections - Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix) - Pregnant or lactating women |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Community based hemato-oncology medical office | Ansbach | |
| Germany | Community based hemato-oncology medical office | Aschaffenburg | |
| Germany | Community based hemato-oncology medical office | Celle | |
| Germany | St.-Johannes-Hospital | Dortmund | |
| Germany | Städtische Kliniken Esslingen | Esslingen | |
| Germany | Universitätsklinik Frankfurt | Frankfurt am Main | |
| Germany | Universitätsklinik Freiburg | Freiburg | |
| Germany | Community based hemato-oncology medical office | Fürth | |
| Germany | University Clinic | Med. Cinic IV Justus-Liebig-University | Gießen | |
| Germany | Wilhelm-Anton-Hospital | Goch | |
| Germany | Kath. Krankenhaus Hagen gem. GmbH | Hagen | |
| Germany | Community based hemato-oncology medical office | Halle | |
| Germany | Community based hemato-oncology medical office | Hamburg | |
| Germany | Meditinische Hochschule (MHH) | Hannover | |
| Germany | Community based hemato-oncology medical office | Heidelberg | |
| Germany | Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum | Herne | |
| Germany | Community based hemato-oncology medical office | Hilden | |
| Germany | Community based hemato-oncology medical office | Hildesheim | |
| Germany | Klinikum Idar-Oberstein | Idar-Oberstein | |
| Germany | Community based hemato-oncology medical office | Jena | |
| Germany | Community based hemato-oncology medical office | Kassel | |
| Germany | Community based hemato-oncology medical office | Kiel | |
| Germany | Community based hemato-oncology medical office | Koblenz | |
| Germany | Community based hemato-oncology medical office | Kronach | |
| Germany | Community based hemato-oncology medical office | Leer | |
| Germany | Community based hemato-oncology medical office | Leipzig | |
| Germany | Städtische Kliniken | Leverkusen | |
| Germany | Community based hemato-oncology medical office | Magdeburg | |
| Germany | Community based hemato-oncology medical office | Marburg | |
| Germany | Community based hemato-oncology medical office | München | |
| Germany | Community based hemato-oncology medical office | München | |
| Germany | Klinikum Großhadern | München | |
| Germany | Klinik Schwäbisch Gmünd / Staufer Klinik | Mutlangen | |
| Germany | Community based hemato-oncology medical office | Neunkirchen | |
| Germany | Community based hemato-oncology medical office | Neuwied | |
| Germany | Community based hemato-oncology medical office | Niddatal | |
| Germany | Community based hemato-oncology medical office | Nürnberg | |
| Germany | MVZ Klinikum Osnabrück | Osnabrück | |
| Germany | Community based hemato-oncology medical office | Pforzheim | |
| Germany | Klinikum Ernst von Bergmann gGmbH | Potsdam | |
| Germany | St. Josefs-Krankenhaus | Potsdam | |
| Germany | Community based hemato-oncology medical office | Schweinfurt | |
| Germany | St. Marien-Krankenhaus | Siegen | |
| Germany | Community based hemato-oncology medical office | Straubing | |
| Germany | Diakonie-Klinikum Stuttgart | Stuttgart | |
| Germany | Community based hemato-oncology medical office | Villingen | |
| Germany | Community based hemato-oncology medical office | Wolfsburg |
| Lead Sponsor | Collaborator |
|---|---|
| Jurgen Barth |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Acute and late toxicity | All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured | From day 1 of treatment period up to 120 months | Yes |
| Other | Degree of induced immunodeficiency | Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured. Duration of immunosupression as well as infectious and other complications which result from therapy will be reported |
From day 1 of treatment period up to 120 months | Yes |
| Other | Frequency of secondary neoplasia during the life-long follow-up period | Rate of secondary neoplasia as safety issue will be determined | From day 1 of treatment period up to 120 months | Yes |
| Other | Overall survival (OS) | Determination of the overall survival times of all patients | From achieving a remission until death | No |
| Primary | Rate of complete remissions (CR) | Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab in patients with hairy cell leukaemia variant in patients with relapsed hairy cell leukaemia |
4 months after treatment | No |
| Secondary | Overall remission rate (ORR) | The rate of CR + PR will be determined | 4 months after treatment | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01087333 -
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
|