At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 119 enrolled
Drug / intervention
inotuzumab ozogamicin +3 moredrug
Likely dose
inotuzumab ozogamicin 1.8 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating inotuzumab ozogamicin and Rituximab for B-Cell Lymphoma. Completed, enrolled 119 participants across 38 sites in 13 countries.
Detailed Summary
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-Cell Lymphoma
CountriesAustralia, Belgium, France, Germany, Hong Kong, Italy, Netherlands, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsUCB Pharma
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2006
Enrollment StartMay 2006
Primary CompletionMay 2014
Study CompletionJun 2014
TodayJul 2026
First PostedMar 6, 2006
Enrollment StartMay 4, 2006
Primary CompletionMay 19, 2014
Study CompletionJun 2, 2014
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 20.3 years ago
Interventions
inotuzumab ozogamicindrug
IV, 1.8 mg/m2, q4w
inotuzumab ozogamicindrug
IV, 1.8 mg/m2, q4w
inotuzumab ozogamicindrug
IV, 1.8 mg/m2, q4w
Rituximabdrug
rituximab 375 mg/m\^2 via IV infusion on Day 1