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

NCT06977711 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-05

No results posted yet for this study

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

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Loncastuximab

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

DRUG

Roflumilast

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

DRUG

Rituximab

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

DRUG

Cyclophosphamide

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

DRUG

Vincristine

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

DRUG

Doxorubicin

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

DRUG

Prednisone

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

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

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

  • Ricardo Aguiar, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-04-15
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977711 on ClinicalTrials.gov