RecruitingPhase 2NCT06828991

A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP

ctDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients With Untreated DLBCL

Sponsor

Danielle Wallace

Enrollment

40 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Summary

Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important. The ability to measure small amounts of persistent lymphoma (circulating tumor DNA or ctDNA) might allow the investigators to risk stratify patients. If older patients have detectable ctDNA in the blood at the end of six cycles of polatuzumab vedotin, rituximab and dose-attentuated CHP chemotherapy, patients will receive a bispecific antibody called mosunetuzumab. The investigators hypothesize this will result in "clearing" the ctDNA from the blood and result in better disease control and outcomes for patients. The study will also measure the safety of this regimen and the impact on the function of these older patients utilizing a tool called the geriatric assessment.

Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is for older patients with diffuse large B-cell lymphoma (DLBCL) — an aggressive blood cancer — who received a reduced-intensity chemotherapy regimen called Pola-R-mini-CHP and still have detectable cancer DNA in their blood afterward. It tests whether adding a drug called mosunetuzumab (an immunotherapy that helps T cells kill lymphoma cells) as a follow-up treatment improves outcomes. **You may be eligible if...** - You are 70 years or older - You are not eligible for full-strength chemotherapy due to age or health - You have been diagnosed with DLBCL or a related aggressive B-cell lymphoma - You have detectable circulating tumor DNA (ctDNA) in your blood after finishing Pola-R-mini-CHP chemotherapy - You are in reasonably good health (ECOG score 0–2) **You may NOT be eligible if...** - You have no detectable ctDNA after chemotherapy (meaning your cancer is likely in complete remission) - You have active serious infections or autoimmune conditions - You have had a prior organ transplant - Your heart, liver, or kidney function is significantly impaired 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMosunetuzumab

Mosunetuzumab consolidation therapy will consist of 6 cycles of IV mosunetuzumab at the standard ramp-up dosing (Day 1 1mg, Day 8 2mg, D15 60mg, C2D1 60mg, and 30mg on day 1 of the subsequent 21-day cycles)

DEVICEClonoSEQ

Patients with detectable ClonoSEQ at C6D1 who have a PET/CT that shows a CR will receive mosunetuzumab

Locations(1)

Wilmot Cancer Institute

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06828991

Related Trials

Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation

NCT074992711 location

NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)

NCT075021184 locations

Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP

NCT074931091 location

Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL

NCT074931481 location

CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL

NCT073978321 location