Actively Recruiting
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Led by University of Rochester · Updated on 2026-02-09
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to measure circulating tumor DNA (ctDNA) levels in patients with early stage diffuse large B cell lymphoma (DLBCL) to identify markers of treatment failure and to explore ctDNA's use for response-adapted therapy. The study also investigates the relationship between FDG-PET scans and minimal residual disease (MRD) measured by ctDNA in these patients. Participants will receive standard chemoimmunotherapy using the R-CHOP regimen followed by radiation based on established protocols, without radioimmunotherapy. Treatment response will be evaluated using the Deauville criteria via PET scans. Non-invasive ctDNA monitoring will occur at diagnosis and at specific times after therapy completion. During the study, participants will undergo blood tests, physical exams, and PET scans to assess treatment response and ctDNA levels. Quality of life will be measured periodically using the PROMIS scale. Follow-up visits will continue for up to five years to monitor overall survival, progression-free survival, and treatment side effects, ensuring comprehensive assessment of treatment outcomes and safety.
CONDITIONS
Brief Title
A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated limited stage non bulky diffuse large B cell lymphoma (DLBCL) diagnosed by FDG-PET and bone marrow biopsy
- Includes grade 3B follicular lymphoma and transformed indolent lymphoma
- Age 18 years or older
- Measurable disease assessable by FDG-PET
- Access to archived or fresh/frozen tumor biopsies
- No uncontrolled medical conditions
- Adequate heart function with ejection fraction 50% or higher and no unstable angina
- Adequate kidney function with GFR greater than 60
- Adequate liver function with liver tests no greater than twice the upper limit of normal (bilirubin normal or no greater than twice upper limit with Gilbert's disease)
- Adequate bone marrow reserves as judged by complete blood count
You will not qualify if you...
- Pregnancy, positive serum HCG within 28 days before enrollment, or breastfeeding
- Bulky disease larger than 10 cm in any dimension
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 cycles of R-CHOP or as determined by PET results
Participants receive standard chemoimmunotherapy with R-CHOP regimen adapted based on PET response.
Visits occur with each treatment cycle and PET scans after 3 cycles
Duration - Up to 5 years after treatment
Participants are monitored with physical exams, bloodwork, and quality of life assessments to evaluate survival and disease progression.
Physical exams and bloodwork every 3 months in year 1, every 6 months in year 2, then yearly through year 5
Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
R
Robin Boerman
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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