Clinical Trials /

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

NCT03758989

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Grade 3b Follicular Lymphoma
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • DLBCL

Interventions

DrugSynonymsArms
Rituximab PrednisoneBaseline PET
CyclophosphamideBaseline PET
DoxorubicinBaseline PET
VincristineBaseline PET
PrednisoneBaseline 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

NameTypeDescriptionInterventions
Baseline PETExperimentalR-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 1, 2020