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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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) is a Phase 2 interventional studying Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Danielle Wallace. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diffuse Large B-Cell Lymphoma (DLBCL) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note. If 80 or older, the reason for dose-attenuated chemoimmunotherapy is assumed to be age. 2. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2. 3. Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma 4. Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy but must not have received an anthracycline-containing regimen in the past. 5. Composite and discordant lymphomas containing both indolent and large cell features will be included. 6. Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions: a course of corticosteroids given for lymphoma related symptoms or one cycle of anthracycline containing chemotherapy prior to enrollment on the clinical trial. Pre-phase treatment with polatuzumab vedotin and steroids is allowable at the treating investigator's discretion. 7. Ejection fraction of ≥ 45% on echocardiogram or MUGA 8. Patient has a platelet count of ≥75,000/µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the platelet count should be ≥ 30,000/µL 9. Patient has an absolute neutrophil count of ≥1,500/ µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the neutrophil count should be ≥500/ µL ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 1. Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note. If 80 or older, the reason for dose-attenuated chemoimmunotherapy is assumed to be age. 2. ECOG performance status of 0-2. 3. Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma 4. Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy but must not have received an anthracycline-containing regimen in the past. 5. Composite and discordant lymphomas containing both indolent and large cell features will be included. 6. Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions: a course of corticosteroids given for lymphoma related symptoms or one cycle of anthracycline containing chemotherapy prior to enrollment on the clinical trial. Pre-phase treatment with polatuzumab vedotin and steroids is allowable at the treating investigator's discretion. 7. Ejection fraction of ≥ 45% on echocardiogram or MUGA 8. Patient has a platelet count of ≥75,000/µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the platelet count should be ≥ 30,000/µL 9. Patient has an absolute neutrophil count of ≥1,500/ µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the neutrophil count should be ≥500/ µL 10. Patient has a calculated or measured creatinine clearance of \>40 mL/minute within the screening period. 11. Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome or hepatic involvement with aggressive B-cell lymphoma in which case it can be ≤ 3.0 times the ULN. ALT or AST must be ≤ 2.5 times the ULN. 12. Patient has, with treatment in the opinion of the treating investigator, a life expectancy of at least 12 weeks. 13. Signed Informed Consent Form 14. Ability to comply with the study protocol Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be enrolled to this study: 1. History of, or clinically apparent central nervous system (CNS) lymphoma 2. Primary mediastinal B-cell lymphoma 3. Patient is receiving peritoneal dialysis or hemodialysis 4. Patient has \> Grade 1 peripheral neuropathy. 5. EF \<45% or significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina 6. Patient has received other investigational drugs within 28 days before enrollment. 7. Prior exposure to anthracycline 8. Patient has concomitant active malignancy that the treating physician or PI feels may interfere with the ability to measure the primary or secondary outcomes. Patients with stage 1 cancers are eligible after definitive treatment. Patients with low grade prostate cancer who are managed with observation are eligible. Patients with other malignancies that have been treated with curative intent may be included after discussion with the study PI. 9. Participants who have a positive HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count \>/= 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months. 10. Patient has active hepatitis B with a positive surface antigen or viral load. Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis throughout study participation according to national and local guidelines. Those at high risk of reactivation should be placed on appropriate antiviral therapy as per national guidelines. 11. History of solid organ transplantation, or post-transplant lymphoproliferative disorder. 12. Patient has history of allogeneic stem cell transplantation. 13. Serious medical or psychiatric illness likely to interfere with participation in this clinical study including clinically significant CNS disease, active infections, or autoimmune disease that in the opinion of the treating investigator impacts their ability to safely participate in the clinical trial. 14. Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention. 15. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (\>20 mg), azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents within 2 weeks prior to Day 1 of the first cycle of mosunetuzumab. The use of inhaled corticosteroids is permitted, as is the use of mineralocorticoids for management of orthostatic hypotension and a dose of dexamethasone 20mg or less for nausea or B symptoms.

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Wilmot Cancer Institute
Rochester, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06828991), the sponsor (Danielle Wallace), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06828991 clinical trial studying?

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 a… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06828991?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06828991?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06828991. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06828991. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.