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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758989
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Carla Casulo, University of Rochester

Study Description
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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.

Condition or disease Intervention/treatment Phase
DLBCL Drug: Rituximab Prednisone Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Baseline PET
R-CHOP
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. PET CR rate [ Time Frame: 5 years ]
  2. Change in minimal residual disease (MRD) from baseline to time of re-staging PET [ Time Frame: 5 years ]
  3. Re-staging Deauville score of 1, 2, or 3 (negative PET scan) [ Time Frame: 5 years ]
  4. 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 ]
  5. Toxicity rates using CTCAE v4.03 [ Time Frame: 5 years ]
  6. 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 ]
  7. 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. ]
  8. Progression free survival (PFS) [ Time Frame: From time of baseline scan through two years of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758989


Contacts
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Contact: Robin Boerman 585-273-1507 Robin_Boerman@URMC.Rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Andrew Bui         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Carla Casulo University of Rochester
More Information
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Responsible Party: Carla Casulo, Associate Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT03758989    
Other Study ID Numbers: ULYM18040
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents