Status:
RECRUITING
A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Lead Sponsor:
University of Rochester
Conditions:
DLBCL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 trea...
Detailed Description
The long-term objective of this proposal is to determine the correlation between FDG-PET and MRD, as measured by ctDNA in patients with early stage DLBLC. Patients will be treated with standard chemo...
Eligibility Criteria
Inclusion
- 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
- Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
- Bulky disease greater than 10 cm in any dimension
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03758989
Start Date
May 8 2019
End Date
June 1 2027
Last Update
January 8 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642