Study on PET Adapted Therapy and Non-Invasive Monitoring for Untreated Early Stage Diffuse Large B Cell Lymphoma

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03758989

Provider View

This clinical trial is exploring a new approach to monitor and treat early stage Diffuse Large B Cell Lymphoma (DLBCL) using PET scans and blood tests to track tumor DNA. The goal is to identify early signs of treatment failure and improve therapy response.

Patient Parameters

Program Overview

The main aim of this study is to measure tumor DNA levels in the blood of patients with early stage Diffuse Large B Cell Lymphoma (DLBCL) and observe how these levels change during treatment. This could help identify early signs of treatment not working and use this information to adjust future treatments.

Description

This study is investigating the relationship between PET scans and minimal residual disease (MRD) by measuring tumor DNA in the blood of patients with early stage DLBCL. Patients will receive standard chemotherapy and radiation therapy, similar to the SWOG S1001 study, but without radioimmunotherapy. The response to treatment will be evaluated using the Deauville criteria. Blood tests to monitor tumor DNA will be conducted at diagnosis and at specific times after treatment to track disease status without invasive procedures.

Eligibility Criteria

Inclusion Criteria

  • Have not received treatment for early stage non-bulky Diffuse Large B Cell Lymphoma (DLBCL), as determined by standard staging methods including PET scans and bone marrow biopsies.
  • Includes patients with grade 3B follicular lymphoma and transformed indolent lymphoma.
  • Aged 18 years or older.
  • Have measurable disease that can be seen on PET scans.
  • Access to previous or new tumor biopsy samples.
  • No uncontrolled medical conditions.
  • Sufficient heart function (ejection fraction of 50% or higher) and no unstable chest pain.
  • Good kidney function (GFR over 60).
  • Good liver function, with liver tests no more than twice the normal limit, unless there's a history of Gilbert's disease.
  • Adequate blood cell levels as determined by the study doctor.

Exclusion Criteria

  • Pregnant or breastfeeding women, or those with a positive pregnancy test within 28 days before joining the study.
  • Have a large tumor mass greater than 10 cm in any dimension.

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