NCT00337987View on ClinicalTrials.gov

A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

December 31, 2007

Study Completion Date

January 31, 2008

Conditions
Peripheral T-Cell Lymphoma
Interventions
DRUG

Ontak

ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia

DRUG

CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy

ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia

Trial Locations (1)

06520

Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Yale University

OTHER

NCT00337987 - A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma | Biotech Hunter | Biotech Hunter