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

NCT03458546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-02-21

No results posted yet for this study

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

Conditions

  • Lymphoma, B-Cell

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Adolfo E Diaz Duque, MD · Mays Cancer Center, UT Health San Antonio

  • Ricardo Aguiar, MD, PhD · Mays Cancer Center, UT Health San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-12-31
Completion
2024-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458546 on ClinicalTrials.gov