Lymphoma, T-Cell, CutaneousPhase 4NCT00050999
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
A Phase 4 study testing ONTAK in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides, run by Eisai Inc. at 35 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- ONTAK
- How many people
- 195 participants
- Where
- 35 sitesin 10 countries
- Study dates
- Jun 1995to Dec 2006
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- No systemic infections;
- Willingness to be randomized to a placebo treatment only arm;
- ECOG performance status 0 or 1;
Who cannot join
- Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
Germany8 sites
Universitatsklinikum Charite
Berlin
University of Erlangen
Erlangen, 91052
Universitatsklinikum Essen
Essen, 45122
J.W. Goethe University Frankfurt
Frankfurt, 60590
Universitatskrankenhaus Eppendorf
Hamburg, 20246
Universitatsklinikum Mannheim
Mannheim, 68135
Universitatsklinikum Munster
Münster, D-48149
Sektion Dermatologische Onkologie
Tübingen, D-72076
Poland6 sites
Medical Academy in Gdansk, Dept. of Hematology
Gdansk, 80-952
Regional Oncological Center, Dept. of Chemotherapy
Lodz, 93-509
Klinika Hematoonkologii Akademii Medycznej w Lublinie
Lublin, 20-950
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, 61-833
The Medical University of Warsaw, Central Clinical Hospital
Warsaw, 02-097
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
Warsaw, 02-781
Russia6 sites
Blokhin Russian Cancer Research Center, RAMS
Moscow
Burdenko Main Military Clinical Hospital
Moscow
Central Research Institute of Skin and Venereal Diseases
Moscow
Haematology Research Center RAMS
Moscow
St. Petersburg Pavlov State Medical University
Saint Petersburg
Samara Regional Clinical Hospital
Samara, 443095
Australia4 sites
Level 4 Department of Haematology Royal North Shore Hospital
Saint Leonard's, New South Wales, 2065
Mater Misericordiae Adult Hospital
South Brisbane, Queensland, 4101
Westmead Hospital, Department of Haematology
Westmead, New South Wales, 2145
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada3 sites
Cross Cancer Centre
Edmonton, Alberta
Hamilton Regional Cancer Center
Hamilton, Ontario
Jewish General Hospital
Montreal, Quebec
United Kingdom3 sites
St. John's Institute of Dermatology
London
City Hospital
Nottingham
Southampton General Hospital
Southampton
Austria2 sites
LKH Universitatsklinikum Graz
Graz, A-8036
Allgemeines Krankenhaus der Stadt Wien
Vienna, A-1090
United States1 site
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
- Being tested
- ONTAK
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONTAKDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary outcomes (3)
Time-to-Treatment Failure
Time-to-Progression
Duration of Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2003 (estimated)
- Study startJun 1995
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 195 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elyane Lombardy, M.D., Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050999
- Sponsor's protocol ID
- 93-04-11
- Status last verified
- Feb 2008
- First submitted
- 31 Dec 2002
- Last updated
- 5 Mar 2008
- Results posted
- No
Publications
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.
PubMed 32632956Duvic 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.
PubMed 23770157