NCT00452127

A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	PRO131921	Escalating doses by IV infusion

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-05-01
• First posted: 2007-03-27
• Last updated: 2013-01-28