About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial population
Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital
Trial design
Case-control
Prospective
Treatments tested in this trial
CAR-T Therapy
DrugIt 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.
Bispecific antibody
DrugIt 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.
Antibody-Drug Conjugate
DrugIt 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.
Monoclonal antibody
DrugMonoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.
Proteasome Inhibitor
DrugIt blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.
IMiD treatment
DrugImmune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
Survival status is assessed through periodic follow-ups and medical records. Patients lost of follow-up are censored at their last known date of contact. The endpoint is either the date of death documented in medical records or the date of the last known follow-up for patients still alive.
Secondary outcomes
Progression-free survival
Disease progression is determined based on clinical, radiographic, or laboratory data, using the Lugano criteria. Patients without documented progression at the time of analysis are censored at their last assessment date.
Sponsors and contacts
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Sung-Soo Park
Lead sponsor
Seoul St. Mary's Hospital
Sponsor institution
Yeouido St. Mary's Hospital
Collaborator