Immunotherapy in Lymphoma
NCT06796517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 72
Last updated 2025-01-28
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.
Conditions
- Relapsed/refractory High Grade B Cell Lymphoma
- High Grade B-cell Lymphoma
- Diffuse Large B Cell Lymphoma Relapsed
- Primary Mediastinal Large B-Cell Lymphoma
- Burkitt Lymphoma
Interventions
- DRUG
-
CAR-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.
- DRUG
-
Bispecific 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.
- DRUG
-
Antibody-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.
- DRUG
-
Monoclonal 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.
- DRUG
-
Proteasome 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.
- DRUG
-
IMiD 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.
Sponsors & Collaborators
-
Yeouido St. Mary's Hospital
collaborator OTHER -
Sung-Soo Park
lead OTHER
Eligibility
- Min Age
- 19 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-26
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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