NCT03758989 A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
| NCT ID | NCT03758989 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Rochester |
| Condition | DLBCL |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-05-08 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2019-05-08 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Carla Casulo
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT03758989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DLBCL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03758989 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03758989 currently recruiting?
Yes, NCT03758989 is actively recruiting participants. Contact the research team at Robin_Boerman@URMC.Rochester.edu for enrollment information.
Where is the NCT03758989 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03758989 clinical trial?
NCT03758989 is sponsored by University of Rochester. The principal investigator is Carla Casulo at University of Rochester. The trial plans to enroll 40 participants.