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Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211198
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 5, 2008
Tufts Medical Center
National Cancer Institute (NCI)
Ligand Pharmaceuticals
Information provided by:
Eisai Inc.

Brief Summary:

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Cutaneous Drug: ONTAK (denileukin difitox, DAB389IL-2) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
Study Start Date : May 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.

Secondary Outcome Measures :
  1. Physician's Global Assessment (PGA)
  2. Time to Event Variables - Time to response, remission, treatment failure
  3. Response based on the CD25 status
  4. Response based on patient demographics: stage of disease, age, sex, performance status, total dose
  5. Number of cycles completed
  6. 6. Assess safety and tolerability of ONTAK

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
  • Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
  • Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN).
  • Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN.
  • Albumin >3.0 g/dL
  • Adequate renal function as indicated by SCr < or equal to 2.5 mg/dl.
  • ECOG performance status between 0-2.
  • Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
  • Patients over the age of 18 who are willing and able to provide Informed Consent.

Exclusion Criteria:

  • Pathology consistent with peripheral T-cell lymphoma.
  • Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
  • History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
  • Patients who are pregnant or breast feeding.
  • Allergy to or have history of allergy to diphtheria toxin or IL-2.
  • Previous ONTAK® usage.
  • Unstable cardiovascular disease.
  • Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
  • Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211198

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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
New England Medical Center
Boston, Massachusetts, United States
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Eisai Inc.
Tufts Medical Center
National Cancer Institute (NCI)
Ligand Pharmaceuticals
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Study Chair: Francine Foss, M.D. Yale University
Francine Foss, Madeleine Duvic, Larisa Geskin, Joseph Anderson, Pierluigi Porcu, Raymond J. Hohl, Maureen Cooper, Jasmine M. Zain, John Zic, Patrica Hibberd, and Mark Acosta Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2712.

Layout table for additonal information Identifier: NCT00211198    
Obsolete Identifiers: NCT00279396
Other Study ID Numbers: #33
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: February 2008
Keywords provided by Eisai Inc.:
T-cell lymphoma
Additional relevant MeSH terms:
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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