Study Title
Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse (NCT01562990)
Trial Description
The purpose of this study is to determine the recommended dose of CMC544 (inotuzumab ozogamycin) administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.
This trial is sponsored by the Lymphoma Academic Research Association (LYSARC)/ Pfitzer. [1]
Study Data
- Condition:
- Interventions:
- Drugs used in this trial
- rituximab (Rituxam®; Biogen, Inc,/ Genentech, Inc.)
- CMC544 (inotuzumab ozogamycin)
- gemcitabine (Gemzar®; Eli Lilly and Company)
- Oxaliplatine (Eloxatin®; Sanofi-Aventis)
- Drugs used in this trial
- Phase: I & II
- Estimated Enrollment: 11
- Start: December 2012
- Estimated Completion: April 2016
- Last verified: May 2015
Study Schematic
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Last Editorial review: July 30, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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