What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy, targeted therapy, and immunotherapy, have various side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, increased risk of infection, and cytopenias (low blood cell counts). Targeted therapies, like BTK inhibitors, may lead to diarrhea, fatigue, muscle and joint pain, and increased risk of bleeding. Immunotherapy, including checkpoint inhibitors, can result in immune-related adverse effects such as colitis, pneumonitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of Non-Hodgkin's Lymphoma (NHL). Rituximab, an anti-CD20 monoclonal antibody, was one of the first targeted therapies approved and is widely used in various NHL subtypes. Other notable approvals include ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, and venetoclax, a BCL-2 inhibitor, both of which target specific genetic pathways involved in the disease. Additionally, CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel have been approved for certain types of relapsed or refractory NHL, offering personalized treatment options based on genetic markers. These therapies align with the goals of the ILN Biochip trial, which aims to monitor treatment response and detect relapse through genetic markers.

What other types of research exist?

Promising novel alternatives to ILN Biochip for monitoring treatment response and detecting relapse in Non-Hodgkin's Lymphoma patients include: 1) Next-generation sequencing (NGS) technologies for comprehensive genetic profiling, 2) Flow cytometric monitoring for residual disease, particularly post targeted therapies, 3) Real-time polymerase chain reaction (RT-PCR) based gene expression profiling for immune signature quantitation, and 4) Dual screening approaches incorporating fluorescence in situ hybridisation (FISH) and Multiplex Ligation-dependent Probe Amplification (MLPA) for detecting specific genetic abnormalities.

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Nanochip Technology for B-Cell Lymphoma

N/A

Recruiting

Led By Beth Christian, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Receiving treatment with curative intent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special tiny chip to monitor treatment response and detect relapse in patients with diffuse large B-cell lymphoma by checking their blood for specific genetic markers. Rituximab has been a key component in treating diffuse large B-cell lymphoma.

Who is the study for?

This trial is for people with a specific blood cancer called diffuse large B-cell lymphoma (DLBCL) who haven't been treated before. Participants must plan to get all their care at Ohio State University, aim for a cure with treatment, and go through 6 cycles of chemotherapy. They also need to be able to give consent.

What is being tested?

The study is testing nanochip technology (ILN biochip) to see how well it can monitor the effectiveness of treatments in real-time and detect any return of the disease in patients with DLBCL. Researchers are looking for genetic markers that could predict treatment outcomes.

What are the potential side effects?

Since this trial focuses on monitoring technology rather than direct treatment, there may not be side effects related directly to the ILN biochip itself. However, standard chemotherapy side effects apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of untreated lymphoma.

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I am undergoing treatment aimed at curing my condition.

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I am scheduled for 6 chemotherapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Early detection of relapse

Treatment response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (ILN biochip testing)Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Immunotherapy, such as monoclonal antibodies (e.g., rituximab), targets specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system. Targeted therapies, like Bruton tyrosine kinase (BTK) inhibitors, interfere with specific molecules involved in cancer cell growth and survival. Understanding these mechanisms is crucial for NHL patients because it helps in tailoring treatments to individual genetic profiles, improving efficacy, and minimizing side effects. Additionally, detecting genetic markers for treatment response and relapse, as studied in the ILN Biochip trial, can lead to more personalized and timely adjustments in therapy, potentially improving outcomes.