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Completed

NCT Number: NCT00051012

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

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.

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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

  • 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.

Exclusion criteria

  • The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

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 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

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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