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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
Conditions: DLBCL
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: University of Rochester
Location: University of Rochester Rochester New York
Summary
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.
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
Source: ClinicalTrials.gov (NCT03758989). StuddyBuddy aggregates publicly available trial information.