NCT00211185

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, T-Cell, Peripheral

Interventions

Type	Name	Description
DRUG	Denileukin diftitox	Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m\^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
DRUG	Doxorubicin	Doxorubicin will be administered IV at a dosage of 50 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
DRUG	Vincristine	Vincristine will be administered IV at a dosage of 1.4 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
DRUG	Prednisone	Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
OTHER	Pegfilgrastim	Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm\^2) for 2 days post-nadir.

Timeline

• Start date: 2004-03-14
• Primary completion: 2008-08-01
• Completion: 2009-12-23
• First posted: 2005-09-21
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

49 sites across 1 country: United States