A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rituximab Prednisone, Cyclophosphamide, Doxorubicin, Vincristine.
- Who it may be relevant to
- Registry conditions: DLBCL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Overview
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.
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 chemoimmunotherapy and radiation based on the recently completed SWOG S1001 study, however no radioimmunotherapy will be used (NCT01359592). Response to treatment will be determined by contemporary Deauville criteria. Assessment of ctDNA (non-invasive disease monitoring) will be determined at diagnosis and will continue at pre-defined specific time points after therapy is complete.
Interventions
- Drug Rituximab Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma - Drug Cyclophosphamide
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma - Drug Doxorubicin
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma - Drug Vincristine
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma - Drug Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Primary outcome measures
- Correlation between fluorodeoxyglucose positron emission tomography (FDG-PET) and MRD, as measured by circulating tumor plasma DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL). [Time frame: 5 years]
Secondary outcome measures (8)
- PET CR rate [Time frame: 5 years]
- Change in minimal residual disease (MRD) from baseline to time of re-staging PET [Time frame: 5 years]
- Re-staging Deauville score of 1, 2, or 3 (negative PET scan) [Time frame: 5 years]
- Following 3 cycles of R-CHOP, if PET scan demonstrates complete response, defined by Deauville score of 1, 2, or 3 (negative PET scan), radiation therapy will not be required moving forward [Time frame: 5 years]
- Toxicity rates using CTCAE v4.03 [Time frame: 5 years]
- Changes in quality of life using PROMIS scale 10 scale will be administered to patients at the time of diagnosis, at the conclusion of all therapy, and at 12 month intervals [Time frame: 5 years]
- Overall survival (OS) of patients through two years of follow-up. [Time frame: Patients will be assessed by physical exam and routine bloodwork every 3 months in the 1st year after conclusion of treatment, and every 6 months in the second year following treatment. They will be assessed yearly during years 3, 4 and 5.]
- Progression free survival (PFS) [Time frame: From time of baseline scan through two years of follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester — Rochester
Identifiers
NCT: NCT03758989 · ULYM18040