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

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding

Bulky disease greater than 10 cm in any dimension

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

  • Cyclophosphamide

    Drug

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

  • Doxorubicin

    Drug

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

  • Vincristine

    Drug

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

  • Prednisone

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Baseline PETExperimental treatment 5 interventions

Trial outcomes

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).

Time frame
5 years

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov
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