Study Title
Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy (INCA) (NCT01679119)
Trial Description
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin (also known as CMC-544) in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.
There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).
This trial is sponsored by University College London/Pfitzer. [1]
Study Data
- Condition: B-Cell Lymphoma
- Interventions:
- Drugs used in this trial
- Cyclophosphamide (ProCytox®;Baxter Co)
- Vincristine (Oncovin®; Genus Pharmaceuticals/ Thornton & Ross)
- Prednisolone (Orapred®; Concordia Healthcare Corp.)
- rituximab (Rituxam®; Biogen, Inc,/ Genentech, Inc.)
- Inotuzumab Ozogamicin (CMC-544)
- gemcitabine (Gemzar®; Eli Lilly and Company)
- Drugs used in this trial
- Phase: II
- Estimated Enrollment: 132
- Start: October 2013
- Estimated Completion: April 2018
- Last verified: July 2014
Study Schematic
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Last Editorial review: November 10, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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