Lo-RR-CHOP for High-Risk DLBCL

This study is testing a new combination of treatments for people with newly diagnosed, high-risk Diffuse Large B-cell Lymphoma (DLBCL), a type of cancer that starts in white blood cells. You would receive Loncastuximab, Roflumilast, Rituximab, Cyclophosphamide, and Vincristine. The study aims to see how safe these treatments are, how well you tolerate them, and how effective they are at shrinking the tumor. This is a small study, planning to enroll 10 participants. The study status is currently unclear.

Study design
This is a Phase 1, single-arm study, meaning all participants receive the same treatment. It plans to enroll 10 participants.
What's involved
You would receive treatment for 8 cycles, which is up to 24 weeks. This includes IV infusions and oral medication, along with PET-CT scans and blood tests at specific times.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety is measured up to 8 cycles (24 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06977711

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~10 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:LoncastuximabRoflumilastRituximabCyclophosphamideVincristineDoxorubicin

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimation of number of adverse events
Measured over Baseline up to 8 cycles (up to 24 weeks)
Diffuse Large B-cell Lymphoma

NCT06977711

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University Hospital System

    San Antonio, Texasstudy coordinator listed

    Recruiting

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

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Adolfo E Diaz Duque, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
  • Ricardo Aguiar, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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Eligibility criteria

Inclusion

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);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 3 × ULN;
Platelet count ≥ 50,000/µL, with or without transfusion support;
Absolute Neutrophil Count (ANC) ≥ 1000/µL, with or without chronic granulocyte growth factor support;
Hemoglobin ≥8 g/dL, with or without transfusion support.
  • Estimation of number of adverse eventsBaseline up to 8 cycles (up to 24 weeks)

    Estimation of adverse events (AE) and serious adverse events (SAE), graded according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0.