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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: University of Rochester • ClinicalTrials.gov ID: NCT03758989

Registry updated: 2026-10-13
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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.

Interventions

  • Rituximab Prednisone (Drug)
    A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
  • Cyclophosphamide (Drug)
    A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
  • Doxorubicin (Drug)
    A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
  • Vincristine (Drug)
    A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
  • Prednisone (Drug)
    A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Eligibility criteria

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

Conditions

DLBCL

Locations

  • University of Rochester — Rochester, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record