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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine

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