Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

December 31, 2002

Last Updated Date

February 29, 2008

Start Date ^ICMJE

June 1995

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Rate of Response (ORR), defined as CR + CCR + PR

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00050999 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time-to-Treatment Failure
Time-to-Progression
Duration of Response

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome

Intervention ^ICMJE

Drug: ONTAK

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

195

Completion Date

December 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Canada, Germany, Netherlands, Poland, Russian Federation, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00050999

Responsible Party

Study ID Numbers ^ICMJE

93-04-11

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Elyane Lombardy, M.D.

Ligand Pharmaceuticals

Information Provided By

Eisai Inc.

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP