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Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

NCT05796271 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-02-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05796271 on ClinicalTrials.gov