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

Phase 4

Completed

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

• Registration Number: NCT00051012
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-09
• Study First Submitted: 2002-12-31
• Study First Submitted QC: 2003-01-02
• Study First Posted: 2003-01-03
• Primary Completion: 2006-10
• 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: 86

Inclusion Criteria

• Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
• CTCL disease Stage Ia - III.
• History of less than or equal to 3 previous 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 chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
• Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
• No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
• No systemic infections.
• ECOG performance status of 0 or 1.

Exclusion Criteria

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (34)

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

Universitatsklinikum Charite; 🇩🇪 Berlin, Germany

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

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

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

Cross Cancer Centre; 🇨🇦 Edmonton, Alberta, Canada

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

University of Erlangen; 🇩🇪 Erlangen, Germany

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

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

Samara Regional Clinical Hospital; 🇷🇺 Samara, Russian Federation

Universitatsklinikum Essen; 🇩🇪 Essen, Germany

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

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Universitatsklinikum Mannheim; 🇩🇪 Mannheim, Germany

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

LKH Universitatsklinikum Graz; 🇦🇹 Graz, Austria

Peter MacCallum Cancer Institute; 🇦🇺 Melbourne, Victoria, Australia

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

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

Universitatskrankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Oddzial Chorob Wewnetrznych i Hematologii; 🇵🇱 Poznan, Poland

Universitatsklinikum Munster; 🇩🇪 Munster, Germany

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

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

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

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

Haematology Research Center RAMS; 🇷🇺 Moscow, Russian Federation

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

Universitatsspital Zurich Dermatologische Klinik; 🇨🇭 Zurich, Switzerland

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

City Hospital; 🇬🇧 Nottingham, United Kingdom

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