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

NCT03758989 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ULYM18040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL

Outcome Measures

Primary Outcomes (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).

  5 years

Secondary Outcomes (8)

• PET CR rate

  5 years

• Change in minimal residual disease (MRD) from baseline to time of re-staging PET

  5 years

• Re-staging Deauville score of 1, 2, or 3 (negative PET scan)

  5 years

• 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

  5 years

• Toxicity rates using CTCAE v4.03

  5 years

Study Arms (1)

Baseline PET

EXPERIMENTAL

R-CHOP

Drug: Rituximab Prednisone; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Rituximab Prednisone DRUG

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

Baseline PET

Cyclophosphamide DRUG

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

Baseline PET

Doxorubicin DRUG

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

Baseline PET

Vincristine DRUG

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

Baseline PET

Prednisone DRUG

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

Baseline PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
• Bulky disease greater than 10 cm in any dimension

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Carla Casulo

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Boerman

CONTACT

585-273-1507; Robin_Boerman@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Hematology/Oncology

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 29, 2018
• Study Start: May 8, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)