Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25
1 other identifier
interventional
86
8 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 1995
Longer than P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1995
CompletedFirst Submitted
Initial submission to the registry
December 31, 2002
CompletedFirst Posted
Study publicly available on registry
January 3, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 5, 2008
February 1, 2008
11.1 years
December 31, 2002
February 29, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary Outcomes (3)
Time-to-Treatment Failure
Time-to-Progression
Duration of Response
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (34)
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Level 4 Department of Haematology Royal North Shore Hospital
Saint Leonard's, New South Wales, 2065, Australia
Westmead Hospital, Department of Haematology
Westmead, New South Wales, 2145, Australia
Mater Misericordiae Adult Hospital
South Brisbane, Queensland, 4101, Australia
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3002, Australia
LKH Universitatsklinikum Graz
Graz, A-8036, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, A-1090, Austria
Cross Cancer Centre
Edmonton, Alberta, Canada
Hamilton Regional Cancer Center
Hamilton, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Universitatsklinikum Charite
Berlin, Germany
University of Erlangen
Erlangen, 91052, Germany
Universitatsklinikum Essen
Essen, 45122, Germany
J.W. Goethe University Frankfurt
Frankfurt, 60590, Germany
Universitatskrankenhaus Eppendorf
Hamburg, 20246, Germany
Universitatsklinikum Mannheim
Mannheim, 68135, Germany
Universitatsklinikum Munster
Münster, D-48149, Germany
Medical Academy in Gdansk, Dept. of Hematology
Gdansk, 80-952, Poland
Regional Oncological Center, Dept. of Chemotherapy
Lodz, 93-509, Poland
Klinika Hematoonkologii Akademii Medycznej w Lublinie
Lublin, 20-950, Poland
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, 61-833, Poland
The Medical University of Warsaw, Central Clinical Hospital
Warsaw, 02-097, Poland
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
Warsaw, 02-781, Poland
Blokhin Russian Cancer Research Center, RAMS
Moscow, Russia
Burdenko Main Military Clinical Hospital
Moscow, Russia
Central Research Institute of Skin and Venereal Diseases
Moscow, Russia
Haematology Research Center RAMS
Moscow, Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia
Samara Regional Clinical Hospital
Samara, 443095, Russia
Universitatsspital Zurich Dermatologische Klinik
Zurich, Switzerland
St. John's Institute of Dermatology
London, United Kingdom
City Hospital
Nottingham, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Related Publications (1)
Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.
PMID: 23770157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elyane Lombardy, M.D.
Ligand Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 31, 2002
First Posted
January 3, 2003
Study Start
September 1, 1995
Primary Completion
October 1, 2006
Study Completion
December 1, 2006
Last Updated
March 5, 2008
Record last verified: 2008-02