At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
inotuzumab ozogamicin (CMC-544) +1 moredrug
Likely dose
inotuzumab ozogamicin (CMC-544) 1.8 mgfrom 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.
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
In Brief
A Phase 2 clinical trial evaluating inotuzumab ozogamicin (CMC-544) and rituximab for Lymphoma, B-Cell. Completed, enrolled 64 participants across 35 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesFrance, Germany, Singapore, South Korea, United Kingdom, United States
CollaboratorsUCB Pharma
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartJun 2009
Primary CompletionOct 2012
TodayJul 2026
First PostedMar 23, 2009
Enrollment StartJun 8, 2009
Primary CompletionOct 31, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.3 years ago
Interventions
inotuzumab ozogamicin (CMC-544)drug
1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses
rituximabdrug
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