NCT06796517

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Sung-Soo Park · Academic / Other
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study