Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma

The Ohio State University

Status: Active, not recruiting

Conditions: Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; High Grade B-Cell Lymphoma; Diffuse Large B-Cell Lymphoma

Treatments: Procedure: Molecular Nanotechnology

Study type: Interventional

Funder types: Other

Identifiers

NCT03656835

OSU-18154

NCI-2018-01536 (Registry Identifier)

Details and patient eligibility

About

This trial studies how well nanochip technology (immuno-tethered lipoplex nanoparticle [ILN] biochip) works in monitoring treatment response and in detecting relapse in participants with diffuse large B-cell lymphoma. Finding genetic markers for diffuse large B-cell lymphoma may help identify participants with this disease and help predict the outcome of treatment. It is not yet known how well ILN biochip-based testing monitors treatment response or detects relapse in participants with diffuse large B-cell lymphoma.

Full description

PRIMARY OBJECTIVES:

I. Determine whether ILN biochip can be used to detect molecular marker(s) to monitor treatment response in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

II. Determine whether ILN biochip can promote early detection of disease relapse in patients with DLBCL.

OUTLINE:

Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed treatment naive DLBCL. Subtypes including high grade B-cell lymphoma, not otherwise specified (NOS) and de-novo DLBCL including germinal center B-cell type (GCB) and non-GCB subtypes.
• Intent to receive entire care (treatment and follow-up) at Ohio State University (OSU).
• Receiving treatment with curative intent.
• Receiving planned 6 cycles of chemotherapy.
• Ability to consent.

Exclusion criteria

• Transformed lymphomas.
• DLBCL with leukemic presentation.
• Primary central nervous system (CNS) lymphoma.
• Participating in other clinical trial/ receiving experimental therapy.
• Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation.
• Pregnancy (positive serum or urine pregnancy test) or breast feeding.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Diagnostic (ILN biochip testing)

Experimental group

Description:

Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.

Treatment:

Procedure: Molecular Nanotechnology