Using PET scans and blood tests to improve treatment for early stage lymphoma
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
This study is testing if measuring tumor DNA in the blood can help doctors adjust treatment for patients with early stage lymphoma to improve their chances of success.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT03758989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with previously untreated limited stage non-bulky DLBCL.
Not a fit: Patients with uncontrolled medical comorbidities or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with DLBCL.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring treatment response, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.