NCT03458546

Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma

Phase Ib Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy for High-risk Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	Roflumilast	All patients will receive R-CHOP therapy at standard doses according to the standard preparation and infusion procedures of each investigational site, which is to be repeated every 21 days for a total of 6 cycles. All patients will receive a fixed oral dose of one 500 microgram (μg) tablet per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses of roflumilast.

Timeline

• Start date: 2018-05-21
• Primary completion: 2021-12-31
• Completion: 2024-01-16
• First posted: 2018-03-08
• Last updated: 2024-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study