Back to resultsStudy of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) 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: 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).
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
- 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
- Sektion Dermatologische Onkologie
- LUMC, Department of Dermatology
- 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
NCT00050999
Brief Title
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
Official Title
A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
September 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 compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
195 (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:
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).
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
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
Sektion Dermatologische Onkologie
City
Tubingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
LUMC, Department of Dermatology
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
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
32632956
Citation
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Results Reference
derived
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 Cutaneous T-Cell Lymphoma (CTCL) Patients
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