RecruitingPhase 1NCT06977711

Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

10 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants. The aims are: 1. To assess the safety and how well the participants tolerate the treatment 2. Assess the response of the tumor to treatment to estimate complete response 3. Assess the response of the tumor to treatment to estimate progression-free survival


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two drugs — loncastuximab (an antibody-drug that targets a cancer protein called CD19) and roflumilast (an anti-inflammatory medication) — to the standard R-CHOP chemotherapy regimen improves outcomes for people newly diagnosed with aggressive large B-cell lymphoma. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL) and have not yet received treatment - Your lymphoma is stage II, III, or IV with a prognostic score of 2 or higher - You have measurable disease on a scan - Your heart's pumping function is at least 45% - You are able to swallow tablets - You are in reasonably good overall health (ECOG 0 to 2) **You may NOT be eligible if...** - You have already received treatment for lymphoma - You have another active cancer requiring treatment - You are pregnant or breastfeeding - You have a life expectancy of less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLoncastuximab

Intravenous (IV) administration 0.15 mg/kg day 1 cycles 1-2, and 0.075mg/kg day 1, cycles 3-5

DRUGRoflumilast

Oral administration of 500mcg days 1-21, cycles 1-8

DRUGRituximab

IV administration of 375mg/m2 day 1, cycles 1-8

DRUGCyclophosphamide

IV administration of 750mg/m2 day 1, cycles 3-8

DRUGVincristine

IV administration 1.4mg/m2 (max 2mg) day 1, cycles 3-8

DRUGDoxorubicin

IV administration 50mg/m2 day 1, cycles 3-8

DRUGPrednisone

Oral administration 100mg/days 1-5, cycles 3-8


Locations(2)

University Hospital System

San Antonio, Texas, United States

University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06977711


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