RecruitingNCT06796517

Immunotherapy in Lymphoma

Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed/Refractory Lymphoma Patients


Sponsor

Sung-Soo Park

Enrollment

72 participants

Start Date

Jun 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is: Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies? Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes. Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.


Eligibility

Min Age: 19 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This observational study collects data on real-world outcomes for patients with aggressive B-cell lymphomas (including diffuse large B-cell lymphoma and Burkitt lymphoma) who have received immunotherapy drugs as part of treatment for their cancer that came back or stopped responding. Researchers want to understand how these patients do in practice. **You may be eligible if...** - You are between 19 and 74 years old - You were diagnosed with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or Burkitt lymphoma after January 2015 - You received immunochemotherapy (a combination of immune and chemotherapy drugs) for relapsed or refractory disease **You may NOT be eligible if...** - Your lymphoma progressed into acute leukemia - You developed a solid tumor during lymphoma treatment - You have active infections such as acute pneumonia, hepatitis B, or tuberculosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCAR-T Therapy

It uses the patient's own T cells, and requires a manufacturing process to modify and expand T cells before infusion. It directly targets B cell specific antigens, such as CD19 or CD20.

DRUGBispecific antibody

It uses a dual targeting mechanism to enhance specificity and immune activation. It is an off-the-shelf treatment, and doesn't require a manufacturing process of patient cells.

DRUGAntibody-Drug Conjugate

It is a targeted therapy consisting of a monoclonal antibody linked to a cytotoxic drug. The antibody binds to a specific antigen on cancer cells, delivering the cytotoxic agent directly to the tumor, minimizing systemic toxicity.

DRUGMonoclonal antibody

Monoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.

DRUGProteasome Inhibitor

It blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.

DRUGIMiD treatment

Immune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.


Locations(2)

Seoul St. Mary Hospital

Seoul, South Korea

Yeoido St. Mary Hospital

Seoul, South Korea

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NCT06796517


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