Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05796271
Phase
PHASE1
Status
Withdrawn

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • R-Chop and Roflumilast — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Feb 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Anti-tumor efficacy: progression-free survival (PFS) [ Time Frame: Measured every 3 weeks for 21 day cycles for the duration of study treatment, from Baseline to approximately one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mays Cancer Center, UT Health San AntonioSan AntonioTexas78229-

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Mays Cancer Center, UT Health San Antonio· San Antonio, TX

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