Using PET scans and blood tests to improve treatment for early stage lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to measure circulating tumor DNA (ctDNA) levels in patients with early stage diffuse large B cell lymphoma (DLBCL) to identify markers of treatment failure and adapt therapy accordingly. Patients will receive standard chemoimmunotherapy and radiation, with treatment response assessed using contemporary Deauville criteria. The correlation between FDG-PET imaging and minimal residual disease (MRD) as indicated by ctDNA will be evaluated at various time points throughout the treatment process.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Rochester
  Rochester, New York, United States Recruiting

Study contacts

• Principal investigator: Carla Casulo — University of Rochester
• Study coordinator: Robin Boerman
• Email: Robin_Boerman@URMC.Rochester.edu
• Phone: 585-273-1507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.