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Recruiting Phase 2

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

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About this study

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.

Condition
DLBCL
Tested
Rituximab Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Sponsor
University of Rochester

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Study condition: DLBCL
  • 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 2

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

Where

1 site, 1 recruiting

University of Rochester

Rochester, New York, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.