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

Phase 2

Not yet recruiting

• Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
• Interventions: Drug: Mosunetuzumab

• Registration Number: NCT06828991
• Lead Sponsor: Danielle Wallace

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Study Start: 2025-09-01
• Primary Completion: 2029-04-01
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ctDNA positive	Mosunetuzumab	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 Measures

Name	Time	Method
ctDNA clearance rate after mosunetuzumab treatment	From the beginning to the end of mosunetuzumab treatment at 18 weeks	The primary endpoint of the trial is the ctDNA clearance rate after mosunetuzumab treatment among the subset of patients in a PET/CT CR but with ctDNA+ at the end of 6 cycles of R-pola-mini-CHP. The rate will be calculated as the number of subjects ctDNA- after mosunetuzumab treatment among all patients treated with mosunetuzumab as part of the Fleming two-stage design.

Secondary Outcome Measures

Name	Time	Method
Objective response rate and complete response rate of pola-R-mini-CHP	From enrollment to the end of pola-R-mini-CHP treatment at 18 weeks	Objective response rate is the number of patients in the study population who achieve a complete or partial response to therapy, the complete response rate is only those patients who achieve a complete response.

Trial Locations

Locations (1)

Wilmot Cancer Institute; 🇺🇸 Rochester, New York, United States