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

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Rituximab Prednisone
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone
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Where

1 site
University of Rochester
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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