Actively Recruiting
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
Led by Danielle Wallace · Updated on 2025-10-20
40
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
Sponsors
D
Danielle Wallace
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 70 years or older who are ineligible for full-intensity chemoimmunotherapy
- ECOG performance status of 0 to 2
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma NOS, or grade 3b follicular lymphoma
- Histologic transformation confirmed by biopsy, with no prior anthracycline-containing treatment for aggressive lymphoma
- Composite and discordant lymphomas containing both indolent and large cell features
- No prior therapy for aggressive B-cell lymphoma or histologic transformation except limited corticosteroids or one cycle of anthracycline chemotherapy
- Ejection fraction of 45% or higher
- Platelet count of at least 75,000/µL unless due to bone marrow involvement, then at least 30,000/µL
- Absolute neutrophil count of at least 1,500/µL unless due to bone marrow involvement, then at least 500/µL
- Creatinine clearance over 40 mL/min
- Total bilirubin less than 1.5 times the upper limit of normal unless due to Gilbert syndrome or lymphoma involvement (up to 3 times allowed)
- ALT or AST less than or equal to 2.5 times the upper limit of normal
- Life expectancy of at least 12 weeks as judged by treating investigator
- Signed informed consent form
- Ability to comply with study protocol
You will not qualify if you...
- History of or active central nervous system lymphoma
- Primary mediastinal B-cell lymphoma
- Receiving peritoneal dialysis or hemodialysis
- Peripheral neuropathy greater than grade 1
- Ejection fraction below 45% or significant cardiovascular disease including recent myocardial infarction, unstable arrhythmias, or unstable angina
- Use of investigational drugs within 28 days before enrollment
- Prior anthracycline exposure
- Active malignancy that interferes with study outcomes, except treated stage 1 cancers or low grade prostate cancer under observation
- Positive HIV test without stable anti-retroviral therapy, adequate CD4 count, undetectable viral load, and no recent opportunistic infections
- Active hepatitis B infection with positive surface antigen or viral load
- History of solid organ transplantation or post-transplant lymphoproliferative disorder
- History of allogeneic stem cell transplantation
- Serious medical or psychiatric illnesses interfering with study participation
- Significant abnormal lab results that would affect safety or evaluation
- Treatment with systemic immunosuppressive medications within 2 weeks prior to first mosunetuzumab cycle, except permitted corticosteroids and other specified agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
D
Danielle Wallace, MD
CONTACT
C
Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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