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

Inclusion Criteria3

  • Adults aged 19 to 74 years.
  • Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma
  • Patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma

Exclusion Criteria3

  • Patients who have progressed to acute leukemia
  • Patients who developed solid tumor during treatment
  • Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)

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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