drugset / Trial / NCT03283202

Study of Safety and Efficacy of Avadomide (CC-122) Combined With RCHOP for Newly-diagnosed DLBCL With Poor Risk Factors

NCT03283202

Phase 1 Completed 35 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

This is Phase 1/2 study of avadomide (CC-122) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, for first-line treatment of patients with Diffuse B-Cell Large B-Cell Lymphoma (DLBCL) that has poor risk factors. Approximately 40% of patients diagnosed with DLBCL are not cured with R-CHOP alone and would need additional treatment for DLBCL in the future. The addition of the experimental drug avadomide (CC-122) with R-CHOP could help in controlling DLBCL in this patient population.

Timeline

Start
2017-10-04
Primary completion
2019-07-30
Completion
2020-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Avadomide Other / unclassified Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous