Clinical Trial: Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.


Detailed Summary:
Sponsor: Eisai Inc.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Physician's Global Assessment (PGA)
  • Time to Event Variables - Time to response, remission, treatment failure
  • Response based on the CD25 status
  • Response based on patient demographics: stage of disease, age, sex, performance status, total dose
  • Number of cycles completed
  • 6. Assess safety and tolerability of ONTAK


Original Secondary Outcome:

  • 1. Physician's Global Assessment (PGA)
  • 2. Time to Event Variables - Time to response, remission, treatment failure
  • 3. Response based on the CD25 status
  • 4. Response based on patient demographics: stage of disease, age, sex, performance status, total dose
  • 5. Number of cycles completed
  • 6. Assess safety and tolerability of ONTAK


Information By: Eisai Inc.

Dates:
Date Received: September 13, 2005
Date Started: May 2001
Date Completion:
Last Updated: February 29, 2008
Last Verified: February 2008