A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
NCT ID: NCT03758989
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2019-05-08
2027-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Baseline PET
R-CHOP
Rituximab Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Cyclophosphamide
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Doxorubicin
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Vincristine
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Interventions
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Rituximab Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Cyclophosphamide
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Doxorubicin
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Vincristine
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Prednisone
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
Eligibility Criteria
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Inclusion Criteria
* 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
* Bulky disease greater than 10 cm in any dimension
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Carla Casulo
Associate Professor of Hematology/Oncology
Principal Investigators
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Carla Casulo
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew Bui
Role: primary
Other Identifiers
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ULYM18040
Identifier Type: -
Identifier Source: org_study_id
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