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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00050999




Registration number
NCT00050999
Ethics application status
Date submitted
31/12/2002
Date registered
3/01/2003
Date last updated
5/03/2008

Titles & IDs
Public title
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
Scientific 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
Secondary ID [1] 0 0
93-04-11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, T-Cell, Cutaneous 0 0
Mycosis Fungoides 0 0
Sezary Syndrome 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ONTAK

Treatment: Drugs: ONTAK
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Rate of Response (ORR), defined as CR + CCR + PR
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time-to-Treatment Failure
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Time-to-Progression
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2
(previous candidate compound evaluated in a clinical setting).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/1995
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Level 4 Department of Haematology Royal North Shore Hospital - St. Leonard's
Recruitment hospital [2] 0 0
Westmead Hospital, Department of Haematology - Westmead
Recruitment hospital [3] 0 0
Mater Misericordiae Adult Hospital - South Brisbane
Recruitment hospital [4] 0 0
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2065 - St. Leonard's
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Erlangen
Country [9] 0 0
Germany
State/province [9] 0 0
Essen
Country [10] 0 0
Germany
State/province [10] 0 0
Frankfurt
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Mannheim
Country [13] 0 0
Germany
State/province [13] 0 0
Munster
Country [14] 0 0
Germany
State/province [14] 0 0
Tubingen
Country [15] 0 0
Netherlands
State/province [15] 0 0
Leiden
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Lodz
Country [18] 0 0
Poland
State/province [18] 0 0
Lublin
Country [19] 0 0
Poland
State/province [19] 0 0
Poznan
Country [20] 0 0
Poland
State/province [20] 0 0
Warsaw
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Samara
Country [23] 0 0
Russian Federation
State/province [23] 0 0
St. Petersburg
Country [24] 0 0
Switzerland
State/province [24] 0 0
Zurich
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Nottingham
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00050999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elyane Lombardy, M.D.
Address 0 0
Ligand Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00050999