NCT05796271

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy for High-risk Diffuse Large B-cell Lymphoma (CTMS# 22-0016)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study is an investigator-initiated, phase II, single arm, open label clinical trial that will enroll subjects 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. All subjects will receive investigational drug, and outcomes will be compared to historical controls.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	R-Chop and Roflumilast	All subjects 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 (+/- 3 days) for a total of 6 cycles. All subjects will receive a fixed oral dose of one 500 microgram (μg) tablet of roflumilast per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses. Subjects will be asked to keep a drug diary to record the days and times when Roflumilast is taken. The first dose will be given on the day of the first R-CHOP treatment.

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2023-04-03
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study