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

Part of paid clinical trials in Rochester, New York.

Sponsor
Danielle Wallace
Study ID
NCT06828991
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    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)
  • ClonoSEQ — DEVICE
    Patients with detectable ClonoSEQ at C6D1 who have a PET/CT that shows a CR will receive mosunetuzumab

Study Details

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.

Key Dates

Start date
Sep 4, 2025
Status verified
Oct 2025
Primary completion
Apr 1, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA positive
    Patients who have achieved a radiographic complete response (CR) on PET/CT, but have detectable ctDNA at the end of treatment with pola-R-mini-CHP will receive 6 cycles of mosunetuzumab consolidation. Patients who have achieved a CR with undetectable ctDNA will be observed. Patients with a partial response on PET/CT will be managed per protocol.

Primary Outcome Measure

ctDNA clearance rate after mosunetuzumab treatment [ Time Frame: From the beginning to the end of mosunetuzumab treatment at 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmot Cancer InstituteRochesterNew York14642
Danielle Wallace, MD
[email protected]
585-273-5761
Danielle Wallace, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Wilmot Cancer Institute· Rochester, NY

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