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Taking people in United StatesPhase 2

Tests blood DNA monitoring during treatment for early diffuse large B cell lymphoma

Measures tumor DNA in blood during treatment in adults with early-stage lymphoma.

Plain-language title generated from the registry record
Registry title: A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Key facts

Where
Rochester, United StatesSee the site
Phase
Phase 2

Where in United States

  • University of RochesterRochester, United StatesTaking people

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Trial details

Who runs it
University of Rochester
Trial code
NCT03758989
Record updated
13 October 2026
Original description
The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.Read full original descriptionShow less

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

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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: Bulky disease greater than 10 cm in any dimension; Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding.

ClinicalTrials.gov NCT03758989