What this study is
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.
What's being tested
- Rituximab Prednisone
Intervention · DRUG
- Cyclophosphamide
Intervention · DRUG
- Doxorubicin
Intervention · DRUG
- Vincristine
Intervention · DRUG
- Prednisone
Intervention · DRUG
All interventions
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Study details
- Official title
- A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
- Sponsor
- University of Rochester
- Conditions
- DLBCL
- Enrolling
- 40 people
- Starts
- 2019-05-08
- Est. completion
- 2027-06-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
- Bulky disease greater than 10 cm in any dimension
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Rochester
Rochester, New York, United States
- Andrew Bui · Contact
Recruiting
Study team
Sponsor
University of Rochester
Study ID ULYM18040
Principal investigator
Carla Casulo
University of Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.