Loncastuximab + Roflumilast for B-Cell Lymphoma

Recruiting at 1 trial location

Overseen By Ricardo E Aguiar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Antidepressants, Antivirals, Antifungals, others

Disqualifiers: Active malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

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

Eligibility Criteria

This trial is for adults with untreated high-risk diffuse large B-cell lymphoma (DLBCL). Participants must have a heart function test showing at least 45% efficiency, be able to swallow pills, and have an acceptable general health status. They should not have had previous treatments for lymphoma or other current cancers, except certain localized ones. People with severe allergies to the study drugs or significant medical conditions that increase risk are excluded.

Inclusion Criteria

Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography

Subject has provided informed consent

Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol

Exclusion Criteria

Allergy or intolerance to roflumilast

Allergy or intolerance to loncastuximab

Current participation in another interventional clinical study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Chemotherapy Free Treatment

Participants receive 2 cycles of chemotherapy free therapy composed of Loncastuximab, Rituximab, and Roflumilast

6 weeks

2 visits (in-person)

Chemoimmunotherapy

Participants receive 6 cycles of chemoimmunotherapy with R-CHOP, Loncastuximab, and Roflumilast

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Loncastuximab
• Roflumilast

Trial Overview The trial tests a combination of drugs: Loncastuximab and Roflumilast added to the standard R-CHOP therapy in patients with DLBCL. It's a phase I study focusing on safety, how well patients tolerate the treatment, tumor response rate, and progression-free survival estimates.

Participant Groups

Group I: Untreated High Risk DLBCL (Diffuse Large B-cell Lymphoma) Experimental Treatment 7 Interventions

Eligible subjects will receive 2 cycles of chemotherapy free therapy composed of Loncastuximab 0.15 mg/kg, Rituximab 375 mg/m2, and Roflumilast 500 ug po daily; followed by 6 cycles of chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at standard of care (SOC) doses, and Roflumilast 500 ug po daily. Loncastuximab at a dose of 0.075 mg/kg will be added to other chemoimmunotherapy agents only for the first three (3) out of six (6) cycles

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+