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

This study has been completed.
Information provided by:
Eisai Inc. Identifier:
First received: December 31, 2002
Last updated: February 29, 2008
Last verified: February 2008

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.

Condition Intervention Phase
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective Rate of Response (ORR), defined as CR + CCR + PR

Secondary Outcome Measures:
  • Time-to-Treatment Failure
  • Time-to-Progression
  • Duration of Response

Estimated Enrollment: 86
Study Start Date: September 1995
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its identifier: NCT00051012

  Show 34 Study Locations
Sponsors and Collaborators
Eisai Inc.
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00051012     History of Changes
Obsolete Identifiers: NCT00005620
Other Study ID Numbers: 93-04-14
Study First Received: December 31, 2002
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014