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OpenTrials
Completed

NCT Number: NCT00050999

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

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.

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Key information

Conditions

Lymphoma, T-Cell, Cutaneous Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Sezary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Level 4 Department of Haematology Royal North Shore Hospital, Saint Leonard's, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ONTAK

Drug

Primary outcomes

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

Secondary outcomes

  1. Time-to-Treatment Failure

  2. Time-to-Progression

  3. Duration of Response

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
2006
Study completion
2006
First posted
Jan 3, 2003
Registry last updated
Mar 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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