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Phosphodiesterase-4 (PDE4) Inhibitor

Roflumilast + Chemotherapy for High-Risk Lymphoma

Phase 1

Waitlist Available

Led By Adolfo E Diaz Duque, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet the following clinical laboratory requirements: - Creatinine clearance ≥30 ml/min by Cockcroft-Gault formula ; - Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis); - AST and ALT≤ 3 × ULN; - Platelet count ≥ 50,000/μL, with or without transfusion support; - ANC ≥ 1000/μL, with or without chronic granulocyte growth factor support; - Hemoglobin ≥8 g/dL, with or without transfusion support.

Pathologically proven diffuse large B-cell lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year

Awards & highlights

Study Summary

This trial will study an experimental treatment for people with a certain type of cancer that has not been treated before.

Who is the study for?

Adults with untreated high-risk diffuse large B-cell lymphoma (DLBCL) who can swallow pills, have a life expectancy of at least 3 months, and are in relatively good health with proper organ function. Participants must not have had previous lymphoma treatments or other active cancers and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing Roflumilast combined with standard chemotherapy in patients with DLBCL. It's an early-phase study (phase Ib), single-arm, meaning all participants receive the same treatment without comparison to a control group.See study design

What are the potential side effects?

Potential side effects of Roflumilast may include digestive issues like nausea or diarrhea, weight loss, headaches, dizziness, mood changes such as depression or insomnia. Chemotherapy can cause fatigue, hair loss, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diffuse large B-cell lymphoma.

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I have not had any drug treatments for lymphoma.

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I am able to get out of my bed or chair and move around.

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My cancer is at stage II, III, or IV according to the Ann Arbor classification.

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I have a lymph node or cancer lesion larger than 1.5 cm and it shows up on PET scans.

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My heart pumps well, with an ejection fraction of 45% or more.

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I have been diagnosed with diffuse large B-cell lymphoma.

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I have a lymph node or cancer lesion larger than 1.5 cm and it shows up on PET scans.

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I have not received any systemic therapy for lymphoma.

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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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