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Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

Phase 4
18 Years
Not Enrolling
Lymphoma, T-Cell, Cutaneous

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Trial Information

Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Francine Foss, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

January 2006

Related Keywords:

  • Lymphoma, T-Cell, Cutaneous
  • Cutaneous
  • T-cell lymphoma
  • CD25
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



University Hospitals of Cleveland Cleveland, Ohio  44106
City of Hope National Medical Center Los Angeles, California  91010
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Vanderbilt University Nashville, Tennessee  37232-6305
Ohio State University Columbus, Ohio  43210
New England Medical Center Boston, Massachusetts  
Yale University School Of Medicine New Haven, Connecticut  06520
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
The University of Iowa Iowa City, Iowa  52242