NCT00562965

Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Detailed description

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	inotuzumab ozogamicin	IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
DRUG	rituximab	IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
DRUG	rituximab	intravenous rituximab at a dose of 375 mg/m2 on day 1
DRUG	cyclophosphamide	intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
DRUG	vincristine	intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
DRUG	prednisone/prednisolone	oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
DRUG	mitoxantrone	mitoxantrone 10 mg/m2 intravenous on day 2
DRUG	fludarabine	fludarabine 25 mg/m2 intravenous on days 2 through 4
DRUG	dexamethasone	oral dexamethasone 20 mg/day on days 1-5

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2007-11-26
• Last updated: 2018-01-09
• Results posted: 2018-01-09

Locations

39 sites across 14 countries: United States, Argentina, Belgium, Canada, Hong Kong, India, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, Spain