NCT00867087

Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	inotuzumab ozogamicin (CMC-544)	1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses
DRUG	rituximab	375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Timeline

• Start date: 2009-06-08
• Primary completion: 2012-10-31
• Completion: 2012-10-31
• First posted: 2009-03-23
• Last updated: 2017-12-05
• Results posted: 2017-08-22

Locations

35 sites across 6 countries: United States, France, Germany, Singapore, South Korea, United Kingdom