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New treatment option for DLBCL
Official title A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
ClinicalTrials.gov ID: NCT03758989
What this study is testing
What is Rituximab Prednisone?
Rituximab Prednisone is an investigational medicine, being studied as a potential treatment for dlbcl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone...
- 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
You likely 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
See the full eligibility 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...
- Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator
- Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
- Bulky disease greater than 10 cm in any dimension
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.