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

A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050999

Enrollment

195

Registered

2003-01-03

Start date

1995-06-30

Completion date

2006-12-31

Last updated

2008-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

Brief summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Interventions

DRUGONTAK

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab; * Patient must have had 1 to 3 prior CTCL 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 regimen is permitted. Topical or systemic steroids are not considered a therapy; * Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry. * Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. * Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow. * No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. * No systemic infections; * Willingness to be randomized to a placebo treatment only arm; * ECOG performance status 0 or 1;

Exclusion criteria

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).

Design outcomes

Primary

Measure	Time frame
Objective Rate of Response (ORR), defined as CR + CCR + PR	—

Secondary

Measure	Time frame
Time-to-Treatment Failure	—
Time-to-Progression	—
Duration of Response	—

Countries

Australia, Austria, Canada, Germany, Netherlands, Poland, Russia, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026