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

Launched by UNIVERSITY OF ROCHESTER · Nov 28, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat and monitor patients with a specific type of lymphoma called diffuse large B cell lymphoma (DLBCL). The study aims to measure levels of circulating tumor DNA (ctDNA) in patients who have not received treatment before. By looking at changes in ctDNA during treatment, researchers hope to identify early signs of treatment failure and eventually use these findings to tailor therapies for patients based on their response.

To participate in this trial, individuals must be at least 18 years old and have a limited stage of DLBCL that hasn't been treated yet. They should also have measurable disease confirmed by imaging tests and no serious medical issues that could interfere with treatment. Participants can expect to undergo regular monitoring throughout the study and may provide samples of their tumor tissue for analysis. This trial is currently recruiting participants, and it is important to discuss any questions or concerns with a healthcare provider to see if this study is a good fit.

Gender

ALL

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