Study of PET Adapted Therapy and Monitoring for DLBCL

This study is looking at how well a combination of standard chemotherapy drugs—Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone—works for people with previously untreated diffuse large B cell lymphoma (DLBCL). Researchers want to see if they can use PET scans and a blood test called circulating tumor DNA (ctDNA) to predict how well treatment is working and to identify markers of treatment failure. The study aims to enroll 40 participants aged 18 or older who have limited stage DLBCL. The main goal is to see how well the PET scan results match the ctDNA levels after 5 years, to help guide future treatments. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is designed to evaluate the correlation between PET scans and ctDNA in patients with early stage DLBCL.
What's involved
Participants will receive standard chemoimmunotherapy and radiation. Blood tests for ctDNA will be taken at diagnosis and at specific times after treatment is complete.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 5 years, suggesting a follow-up period of at least 5 years after treatment.

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NCT03758989

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Rochester
~40 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Rituximab PrednisoneCyclophosphamideDoxorubicinVincristinePrednisone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation between fluorodeoxyglucose positron emission tomography (FDG-PET) and MRD, as measured by circulating tumor plasma DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL).
Measured over 5 years
DLBCL
1 sites across 1 states
New York1
  • Carla Casulo · PRINCIPAL_INVESTIGATOR · University of Rochester

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Eligibility criteria

Inclusion

Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\[21\]
Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included
Ages ≥ 18
Measurable disease, assessable by radiographic examination with FDG-PET showing involvement
Access to archived or fresh/frozen tumor biopsies
No uncontrolled medical comorbidities
Adequate cardiac function (EF \> or equal to 50%), no unstable angina
Adequate renal function (GFR \> 60)
Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease
Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator

Exclusion

Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
Bulky disease greater than 10 cm in any dimension
  • Correlation between fluorodeoxyglucose positron emission tomography (FDG-PET) and MRD, as measured by circulating tumor plasma DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL).5 years