Actively Recruiting
ctDNA-Guided Mosunetuzumab Consolidation Therapy for Older Patients With Untreated Diffuse Large B-Cell Lymphoma
Led by Danielle Wallace · Updated on 2025-10-20
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Danielle Wallace
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying older patients with diffuse large B-cell lymphoma (DLBCL) to understand how to better control the disease and reduce treatment side effects. The study focuses on patients aged 70 and older who have completed initial treatment with polatuzumab vedotin, rituximab, and dose-attenuated CHP chemotherapy. It aims to identify patients who still have small amounts of lymphoma DNA (circulating tumor DNA or ctDNA) in their blood after treatment and evaluate if giving an additional therapy can improve outcomes. The study also assesses the safety of this approach and its effect on patients' physical function using a geriatric assessment tool. Patients who show a complete response on imaging but still have detectable ctDNA will receive six cycles of mosunetuzumab, a bispecific antibody, given intravenously with a specific dosing schedule over 18 weeks. Those with no detectable ctDNA after initial therapy will be observed without additional treatment. Patients with partial response will be managed according to study guidelines. The study uses a device called ClonoSEQ to detect ctDNA in the blood. Participants will undergo regular evaluations including blood tests to measure ctDNA levels, imaging scans, and functional assessments. The main outcome measured is the rate at which ctDNA clears from the blood after mosunetuzumab treatment. Secondary outcomes include response rates to the initial chemotherapy. The study monitors safety and tolerability throughout. Participation lasts through the treatment and observation periods, with assessments scheduled to track disease control and patient health.
CONDITIONS
Brief 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 ineligible for full-intensity chemoimmunotherapy
- ECOG performance status of 0 to 2
- Histologically-confirmed diffuse large B-cell lymphoma or certain related lymphoma types
- Histologic transformation confirmed by biopsy allowed
- Composite and discordant lymphomas included
- No prior therapy for aggressive B-cell lymphoma except corticosteroids or one anthracycline chemotherapy cycle
- Ejection fraction of 45% or higher
- Platelet count of 75,000/µL or higher, or 30,000/µL if due to bone marrow infiltration
- Absolute neutrophil count of 1,500/µL or higher, or 500/µL if due to bone marrow infiltration
- Creatinine clearance greater than 40 mL/min
- Total bilirubin less than 1.5 times upper limit of normal unless due to Gilbert syndrome or lymphoma involvement
- ALT and AST less than 2.5 times upper limit of normal
- Life expectancy of at least 12 weeks as judged by investigator
- Signed informed consent and ability to comply with protocol
You will not qualify if you...
- History or presence of central nervous system lymphoma
- Primary mediastinal B-cell lymphoma
- Receiving peritoneal or hemodialysis
- Peripheral neuropathy greater than grade 1
- Ejection fraction below 45% or significant cardiovascular disease
- Use of other investigational drugs within 28 days
- Prior exposure to anthracycline
- Active malignancy interfering with study except certain treated cancers
- Positive HIV test unless stable on therapy with adequate immune status
- Active hepatitis B infection
- History of solid organ or stem cell transplantation
- Serious medical or psychiatric illness impacting safe participation
- Clinically significant blood chemistry or hematology abnormalities
- Recent treatment with systemic immunosuppressive medications above specified doses except allowed exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 18 weeks
Participants receive 6 cycles of mosunetuzumab consolidation therapy with ramp-up dosing given intravenously to treat their lymphoma.
6 treatment cycles with dosing on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent 21-day cycles
Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
D
Danielle Wallace, MD
C
Clinical Trials Office
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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