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

Primary Purpose

DLBCL

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab Prednisone
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DLBCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baseline PET

Arm Description

R-CHOP

Outcomes

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).

Secondary Outcome Measures

PET CR rate
Change in minimal residual disease (MRD) from baseline to time of re-staging PET
Re-staging Deauville score of 1, 2, or 3 (negative PET scan)
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
Toxicity rates using CTCAE v4.03
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
Overall survival (OS) of patients through two years of follow-up.
Progression free survival (PFS)

Full Information

First Posted
November 15, 2018
Last Updated
October 2, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03758989
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DLBCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline PET
Arm Type
Experimental
Arm Description
R-CHOP
Intervention Type
Drug
Intervention Name(s)
Rituximab Prednisone
Intervention Description
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
PET CR rate
Time Frame
5 years
Title
Change in minimal residual disease (MRD) from baseline to time of re-staging PET
Time Frame
5 years
Title
Re-staging Deauville score of 1, 2, or 3 (negative PET scan)
Time Frame
5 years
Title
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
Title
Toxicity rates using CTCAE v4.03
Time Frame
5 years
Title
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
Title
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.
Title
Progression free survival (PFS)
Time Frame
From time of baseline scan through two years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Boerman
Phone
585-273-1507
Email
Robin_Boerman@URMC.Rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Casulo
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Bui

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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