Recruiting
Phase 2

PET Adapted Therapy

Sponsor:

University of Rochester

Code:

NCT03758989

Conditions

DLBCL

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rituximab Prednisone

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

Study Details

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

Study ID

NCT03758989

Start date

May 8, 2019

Status verified date

Feb, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Baseline PET

R-CHOP

Interventions

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

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

Robin Boerman

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

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-02-09.