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Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT00051012•Eisai Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (34)

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Level 4 Department of Haematology Royal North Shore Hospital

Saint Leonard's, New South Wales, Australia

Westmead Hospital, Department of Haematology

Westmead, New South Wales, Australia

Mater Misericordiae Adult Hospital

South Brisbane, Queensland, Australia

Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Institute

Melbourne, Victoria, Australia

LKH Universitatsklinikum Graz

Graz, Austria

Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Cross Cancer Centre

Edmonton, Alberta, Canada

Hamilton Regional Cancer Center

Hamilton, Ontario, Canada

Key Dates

Start Date

September 1, 1995

Primary Completion Date

October 1, 2006

Completion Date

December 1, 2006

Last Updated

March 5, 2008

Enrollment

Estimated participants

Conditions

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Interventions

ONTAK

DRUG

Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis

NCT06207812

Lymphomatoid PapulosisMycosis Fungoides

View study

RECRUITING

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

NCT06588868

Cutaneous T Cell LymphomaCutaneous T-Cell Lymphoma/Mycosis Fungoides+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

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