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Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

18 Years
Open (Enrolling)
Cutaneous T-Cell Lymphoma, Sezary Syndrome, Mycosis Fungoides

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Trial Information

Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Larisa J. Geskin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:

IRB 0509084



Start Date:

November 2005

Completion Date:

December 2008

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • Sezary Syndrome
  • Mycosis Fungoides
  • Cutaneous T-cell Lymphoma
  • Sezary Syndrome
  • Mycosis Fungoides
  • Denileukin Diftitox
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



University of Pittsubrgh Medical Center Pittsburgh, Pennsylvania  15213