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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/NCT00051012




Registration number
NCT00051012
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 Previously Treated Cutaneous T-Cell Lymphoma Patients
Scientific 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
Secondary ID [1] 0 0
93-04-14
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
- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or
92-04-01.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/09/1995
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,VIC
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 hospital [5] 0 0
Peter MacCallum Cancer Institute - Melbourne
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 postcode(s) [5] 0 0
3002 - Melbourne
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
Poland
State/province [14] 0 0
Gdansk
Country [15] 0 0
Poland
State/province [15] 0 0
Lodz
Country [16] 0 0
Poland
State/province [16] 0 0
Lublin
Country [17] 0 0
Poland
State/province [17] 0 0
Poznan
Country [18] 0 0
Poland
State/province [18] 0 0
Warsaw
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Samara
Country [21] 0 0
Russian Federation
State/province [21] 0 0
St. Petersburg
Country [22] 0 0
Switzerland
State/province [22] 0 0
Zurich
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Nottingham
Country [25] 0 0
United Kingdom
State/province [25] 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00051012
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/NCT00051012