NCT00337987

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

A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.

Conditions

• Peripheral T-Cell Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2006-06-20
• Last updated: 2015-02-27
• Results posted: 2015-02-10

Locations

1 site across 1 country: United States