NCT00022932

Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Intermediate Grade Non-Hodgkin's Lymphoma Following First Line CHOP

Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Corixa Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL) who have achieved a response following 6-8 cycles of CHOP therapy.

Detailed description

The primary endpoint is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure. The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose. The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Iodine-131 Anti-B1 Antibody

Timeline

• Start date: 2000-01-01
• First posted: 2001-08-20
• Last updated: 2005-06-24

Locations

3 sites across 1 country: United States