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Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. Clinical research trials and Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.. Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients. condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.  Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
For Condition: Lymphoma, T-Cell, Cutaneous,Sezary Syndrome,Mycosis Fungoides
Status: Recruiting
Sponsor(s): Ligand Pharmaceuticals ,
Synopsis: The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab. - Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy. - Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry. - Stage IA-III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. - Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow. - No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. - No systemic infections. - Willingness to be randomized to a placebo treatment only arm. - ECOG performance status of 0 or 1
Total Enrollment: 195
Location and Contact Information:
Overall Study Official:
GordonBray, Study Director, Ligand Pharmaceuticals
Cross Cancer Centre *Recruiting*
Edmonton, Alberta,
Canada
Recruiting
Blokhin Russian Cancer Research Center, RAMS *Recruiting*
Moscow, ,
Russian Federation
Recruiting
Universitatsklinikum Munster *Recruiting*
Munster, ,
Germany
Recruiting
Jewish General Hospital *Recruiting*
Montreal, Quebec,
Canada
Recruiting
Universitatsklinikum Charite *Recruiting*
Berlin, ,
Germany
Recruiting
St. Petersburg Pavlov State Medical University *Recruiting*
St Petersburg, ,
Russian Federation
Recruiting
LUMC *Recruiting*
Leiden, ,
Netherlands
Recruiting
University of Erlangen *Recruiting*
Erlangen, ,
Germany
Recruiting
St. John's Institute of Dermatology *Recruiting*
London, ,
United Kingdom
Recruiting
University Clinic , GHS *Recruiting*
ESSEN, ,
Germany
Recruiting
Krankenhaus der Stadt Wien *Recruiting*
Vienna, ,
Austria
Recruiting
Regional Oncological Center, Dept. of Chemotherapy *Recruiting*
Lodz, ,
Poland
Recruiting
Southampton General Hospital *Recruiting*
Southampton, ,
United Kingdom
Recruiting
Central Research Institute of Skin and Venereal Diseases *Recruiting*
Moscow, ,
Russian Federation
Recruiting
Universitatsspital Zurich Dermatologische Klinik *Recruiting*
Zurich, ,
Switzerland
Recruiting
LKH Universitatsklinikum Graz *Recruiting*
Graz, ,
Austria
Recruiting
Hamilton Regional Cancer Center *Recruiting*
Hamilton, Ontario,
Canada
Recruiting
The Medical University of Warsaw, Central Clinical Hospital *Recruiting*
Warsaw, ,
Poland
Recruiting
University of Texas, M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Oncological Center *Recruiting*
Warsaw, ,
Poland
Recruiting
Klinika Hematologii *Recruiting*
Lublin, ,
Poland
Recruiting
Peter MacCallum Cancer Institute *Recruiting*
Melbourne, ,
Australia
Recruiting
J.W. Goethe University Frankfurt *Recruiting*
Frankfurt, ,
Germany
Recruiting
Medical Academy in Warsaw, Central Hospital *Recruiting*
Warsaw, ,
Poland
Recruiting
Haematology Research Center RAMS *Recruiting*
Moscow, ,
Russian Federation
Recruiting
Medical Academy in Gdansk, Dept. of Hematology *Recruiting*
Gdansk, ,
Poland
Recruiting
City Hospital *Recruiting*
Nottingham, ,
United Kingdom
Recruiting
Universitatskrankenhaus Eppendorf *No longer recruiting*
Hamburg, ,
Germany
No longer recruiting
Burdenko Main Military Clinical Hospital *Recruiting*
Moscow, ,
Russian Federation
Recruiting
Additional Information:
Study ID Numbers: 93-04-11;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050999
Other Sezary Syndrome Studies:
1. Open label study of ONTAK (denileukin diftitox) in previously treated Cutaneous T-cell Lymphoma patients.
2. Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
3. Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
4. A Safety/Efficacy Study of SGN-30 (Antibody) in Patients with Refractory or Recurrent CD30+ Hematologic Malignancies
5. Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) with Yttrium-90 Radiolabeled Anti-Tac
Related Studies:
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Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
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