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Clinical Trial Summary

This study is a phase Ib, single arm, open label clinical trial that will enroll patients with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor outcome


Clinical Trial Description

This study is a phase Ib, single arm, open label clinical trial that will enroll patients with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor outcome, defined as an NCCN-IPI score of 2 or higher. Each patient's disease will be biologically characterized at baseline. Enrolled patients will receive chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), administered every 21 days for 6 cycles, which is the standard of care. In addition, all patients will receive the study drug, roflumilast, at the standard dose of 500 μg by mouth once daily, throughout the 18-week treatment period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03458546
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact
Status Completed
Phase Phase 1
Start date May 21, 2018
Completion date January 16, 2024

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