Effect of Denileukin Diftitox on Immune System in CTCL Patients

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
First received: November 15, 2005
Last updated: March 24, 2015
Last verified: December 2007

This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cell lymphoma.

Patients who are undergoing standard of care therapy with denileukin diftitox will be invited to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up to the first 4 cycles of denileukin diftitox.

Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 10
Study Start Date: November 2005
Estimated Study Completion Date: September 2007
Detailed Description:

Although the etiology of CTCL is not fully understood, it is believed to be a malignancy proliferation of a "memory" T-cell in the context of Th2-type cytokine profile and suppressed cytotoxic T-cell (CTL) immunity. T-regulatory (T-regs) cells may be important in CTCL in the setting of immunotherapy. Removal of T-regs would result in enhanced immune responses in vitro, which may translate into augmentation of the anti-tumor immune response and durable clinical responses in vivo. We propose to evaluate effects of ONTAK on the T-reg cell subset in patients undergoing routine therapy with ONTAK. We will evaluate T-reg subsets in peripheral blood and tumor tissues from the patients both phenotypically using multi-color FACS analysis and confocal microscopy, and functionally in MLRs and ELISpot assays with baseline, day 5 and 19 blood samples in up to four cycles.

Completion date provided represents the completion date of the grant per OOPD records


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

Inclusion Criteria:

  • 18 and older
  • diagnosed with CTCL
  • able and willing to provide informed consent
  • will be receiving denileukin diftitox per standard guidelines

Exclusion Criteria:

  • prior history of receiving Ontak
  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00254332

United States, Pennsylvania
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254332     History of Changes
Other Study ID Numbers: IRB 0509084
Study First Received: November 15, 2005
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Denileukin Diftitox

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Denileukin diftitox
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015