Description:
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.
Title
- Brief Title: A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
- Official Title: A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
ULYM18040
- NCT ID:
NCT03758989
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Rituximab Prednisone | | Baseline PET |
| Cyclophosphamide | | Baseline PET |
| Doxorubicin | | Baseline PET |
| Vincristine | | Baseline PET |
| Prednisone | | Baseline PET |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Baseline PET | Experimental | R-CHOP | - Rituximab Prednisone
- Cyclophosphamide
- Doxorubicin
- Vincristine
- Prednisone
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | PET CR rate |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Change in minimal residual disease (MRD) from baseline to time of re-staging PET |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Re-staging Deauville score of 1, 2, or 3 (negative PET scan) |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Toxicity rates using CTCAE v4.03 |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | 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. |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival (PFS) |
| Time Frame: | From time of baseline scan through two years of follow-up |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | University of Rochester |
Last Updated
September 3, 2020
