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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00051012

Enrollment

Registered

2003-01-03

Start date

1995-09-30

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 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.

Interventions

DRUGONTAK

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

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, Poland, Russia, Switzerland, United Kingdom, United States

Outcome results

None listed

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