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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03458546
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    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.

Study Details

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

Key Dates

Start date
May 21, 2018
Status verified
Feb 2023
Primary completion
Dec 31, 2021
Completion
Jan 16, 2024

Study Design

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

Arms

  • Experimental: Roflumilast and R-CHOP

Primary Outcome Measure

To evaluate adverse drug reactions and toxicities as evaluated by NCI CTCAE using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 [ Time Frame: Measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than 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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