Study Title
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin’s Lymphoma (NCT01055496)
Trial Description
This is a phase I trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin (CMC-544), an investigational product, in adults with CD22-positive non-Hodgkin’s lymphoma. The trial will involve two arms.
In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
This trial is sponsored by UCB Pharma/Pfitzer. [1]
Study Data
- Condition: B-Cell Lymphoma
- Interventions:
- Drugs used in this trial
- inotuzumab ozogamicin (CMC-544)
- rituximab (Rituxam®; Biogen, Inc,/ Genentech, Inc.)
- cyclophosphamide (ProCytox®;Baxter Co)
- vincristine sulfate (Oncovin®; Genus Pharmaceuticals/ Thornton & Ross)
- prednisone
- gemcitabine (Gemzar®; Eli Lilly and Company)
- cisplatinum (Platinol®; Bristol-Myers Sqibb)
- dexamethasone (Ozurdex®; Allergan)
- Drugs used in this trial
- Phase: I
- Enrollment: 104
- Start: March 2010
- Completion: March 2014
- Last verified: March 2014
Study Schematic
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Last Editorial review: July 31, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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