Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00050999