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

Not Applicable

Active, not recruiting

• Conditions: Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Diffuse Large B-Cell Lymphoma; High Grade B-Cell Lymphoma
• Interventions: Procedure: Molecular Nanotechnology

• Registration Number: NCT03656835
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Study Start: 2018-09-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-11-19
• Study Completion: 2025-11-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (ILN biochip testing)	Molecular Nanotechnology	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.

Primary Outcome Measures

Name	Time	Method
Treatment response	Up to 2 years	The association of the expression measured by immuno-tethered lipoplex nanoparticle (ILN) biochip and quantitative reverse transcription polymerase chain reaction (qRT-PCR) will be displayed by scatter plot. Receiver operating characteristic (ROC) curves and corresponding area under the curves (AUCs) will be calculated and compared. With these data collected serially over time, patterns will be explored graphically using trace plots showing the trend across treatment for each individual participant.
Early detection of relapse	Up to 2 years	Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States