Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

Phase 4

Completed

• Conditions: Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

• Registration Number: NCT00050999
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-06
• Study First Submitted: 2002-12-31
• Study First Submitted QC: 2003-01-02
• Study First Posted: 2003-01-03
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-29
• Last Update Posted: 2008-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion 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 0 or 1;

Exclusion Criteria

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective Rate of Response (ORR), defined as CR + CCR + PR

Secondary Outcome Measures

Name	Time	Method
Time-to-Progression
Duration of Response
Time-to-Treatment Failure

Trial Locations

Locations (35)

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Medical Academy in Gdansk, Dept. of Hematology; 🇵🇱 Gdansk, Poland

Klinika Hematoonkologii Akademii Medycznej w Lublinie; 🇵🇱 Lublin, Poland

LKH Universitatsklinikum Graz; 🇦🇹 Graz, Austria

Universitatsspital Zurich Dermatologische Klinik; 🇨🇭 Zurich, Switzerland

Cross Cancer Centre; 🇨🇦 Edmonton, Alberta, Canada

Level 4 Department of Haematology Royal North Shore Hospital; 🇦🇺 St. Leonard's, New South Wales, Australia

University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

LUMC, Department of Dermatology; 🇳🇱 Leiden, Netherlands

Universitatsklinikum Charite; 🇩🇪 Berlin, Germany

Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie; 🇵🇱 Warsaw, Poland

Haematology Research Center RAMS; 🇷🇺 Moscow, Russian Federation

Blokhin Russian Cancer Research Center, RAMS; 🇷🇺 Moscow, Russian Federation

Central Research Institute of Skin and Venereal Diseases; 🇷🇺 Moscow, Russian Federation

Universitatsklinikum Essen; 🇩🇪 Essen, Germany

Universitatsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Mater Misericordiae Adult Hospital; 🇦🇺 South Brisbane, Queensland, Australia

Westmead Hospital, Department of Haematology; 🇦🇺 Westmead, New South Wales, Australia

Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

J.W. Goethe University Frankfurt; 🇩🇪 Frankfurt, Germany

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Sektion Dermatologische Onkologie; 🇩🇪 Tubingen, Germany

Hamilton Regional Cancer Center; 🇨🇦 Hamilton, Ontario, Canada

University of Erlangen; 🇩🇪 Erlangen, Germany

Universitatskrankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Universitatsklinikum Munster; 🇩🇪 Munster, Germany

Regional Oncological Center, Dept. of Chemotherapy; 🇵🇱 Lodz, Poland

The Medical University of Warsaw, Central Clinical Hospital; 🇵🇱 Warsaw, Poland

Oddzial Chorob Wewnetrznych i Hematologii; 🇵🇱 Poznan, Poland

St. Petersburg Pavlov State Medical University; 🇷🇺 St. Petersburg, Russian Federation

Burdenko Main Military Clinical Hospital; 🇷🇺 Moscow, Russian Federation

City Hospital; 🇬🇧 Nottingham, United Kingdom

Samara Regional Clinical Hospital; 🇷🇺 Samara, Russian Federation

St. John's Institute of Dermatology; 🇬🇧 London, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom