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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

NCT06828991 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

DRUG

Mosunetuzumab

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)

DEVICE

ClonoSEQ

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Adaptive Biotechnologies

    collaborator INDUSTRY

  • Lymphoma Research Foundation

    collaborator OTHER

  • Danielle Wallace

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2029-04-01
Completion
2030-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06828991 on ClinicalTrials.gov