Clinical Trial: A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

Brief Summary: Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.

Detailed Summary:
Sponsor: Eisai Inc.

Current Primary Outcome: Safety of the combination of ONTAK + CHOP is assessed every 3 weeks for 18 weeks using measures such as ECG, physical exam, weight and performance status, vital signs, and blood chemistry/hematology (every 6 weeks). [ Time Frame: Every 3 weeks or as needed. ]

Original Primary Outcome: Safety of the combination of ONTAK + CHOP is assessed every 3 weeks for 18 weeks using measures such as ECG, physical exam, weight and performance status, vital signs, and blood chemistry/hematology (every 6 weeks).

Current Secondary Outcome: The response rate for the combination is assessed every 6 weeks using measures such as radiological tests for measurable disease and tumor measurements. [ Time Frame: Every 6 weeks. ]

Original Secondary Outcome: The response rate for the combination is assessed every 6 weeks using measures such as radiological tests for measurable disease and tumor measurements.

Information By: Eisai Inc.

Dates:
Date Received: September 13, 2005
Date Started: March 2004
Date Completion:
Last Updated: August 27, 2009
Last Verified: March 2008