Back to resultsStudy of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
Primary Purpose
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ONTAK
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, T-Cell, Cutaneous
Eligibility Criteria
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.
Sites / Locations
- University of Texas, M.D. Anderson Cancer Center
- Level 4 Department of Haematology Royal North Shore Hospital
- Westmead Hospital, Department of Haematology
- Mater Misericordiae Adult Hospital
- Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
- Peter MacCallum Cancer Institute
- LKH Universitatsklinikum Graz
- Allgemeines Krankenhaus der Stadt Wien
- Cross Cancer Centre
- Hamilton Regional Cancer Center
- Jewish General Hospital
- Universitatsklinikum Charite
- University of Erlangen
- Universitatsklinikum Essen
- J.W. Goethe University Frankfurt
- Universitatskrankenhaus Eppendorf
- Universitatsklinikum Mannheim
- Universitatsklinikum Munster
- Medical Academy in Gdansk, Dept. of Hematology
- Regional Oncological Center, Dept. of Chemotherapy
- Klinika Hematoonkologii Akademii Medycznej w Lublinie
- Oddzial Chorob Wewnetrznych i Hematologii
- The Medical University of Warsaw, Central Clinical Hospital
- Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
- Blokhin Russian Cancer Research Center, RAMS
- Burdenko Main Military Clinical Hospital
- Central Research Institute of Skin and Venereal Diseases
- Haematology Research Center RAMS
- Samara Regional Clinical Hospital
- St. Petersburg Pavlov State Medical University
- Universitatsspital Zurich Dermatologische Klinik
- St. John's Institute of Dermatology
- City Hospital
- Southampton General Hospital
Outcomes
Primary Outcome Measures
Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary Outcome Measures
Time-to-Treatment Failure
Time-to-Progression
Duration of Response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051012
Brief Title
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ONTAK
Primary Outcome Measure Information:
Title
Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary Outcome Measure Information:
Title
Time-to-Treatment Failure
Title
Time-to-Progression
Title
Duration of Response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyane Lombardy, M.D.
Organizational Affiliation
Ligand Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Level 4 Department of Haematology Royal North Shore Hospital
City
St. Leonard's
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital, Department of Haematology
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Misericordiae Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
LKH Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Cross Cancer Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Hamilton Regional Cancer Center
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Universitatsklinikum Charite
City
Berlin
Country
Germany
Facility Name
University of Erlangen
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
J.W. Goethe University Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatskrankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Munster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Medical Academy in Gdansk, Dept. of Hematology
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Regional Oncological Center, Dept. of Chemotherapy
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Klinika Hematoonkologii Akademii Medycznej w Lublinie
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych i Hematologii
City
Poznan
ZIP/Postal Code
61-833
Country
Poland
Facility Name
The Medical University of Warsaw, Central Clinical Hospital
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Blokhin Russian Cancer Research Center, RAMS
City
Moscow
Country
Russian Federation
Facility Name
Burdenko Main Military Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Central Research Institute of Skin and Venereal Diseases
City
Moscow
Country
Russian Federation
Facility Name
Haematology Research Center RAMS
City
Moscow
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St. Petersburg
Country
Russian Federation
Facility Name
Universitatsspital Zurich Dermatologische Klinik
City
Zurich
Country
Switzerland
Facility Name
St. John's Institute of Dermatology
City
London
Country
United Kingdom
Facility Name
City Hospital
City
Nottingham
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23770157
Citation
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.
Results Reference
derived
Learn more about this trial
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
We'll reach out to this number within 24 hrs