Burkitt Lymphoma, Diffuse Large B Cell Lymphoma Relapsed, High Grade B-cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma, Relapsed/refractory High Grade B Cell Lymphoma
Conditions
Keywords
immunochemotherapy, B cell lymphoma, Relapsed, Refractory
Brief 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.
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.
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.
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.
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.
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.
Sponsors
Yeouido St. Mary's Hospital
Sung-Soo Park
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From the start of treatment or the date of study enrollment until disease progression or death from any cause, whichever comes first, assessed up to 100 months. | 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. |
Countries
South Korea
Contacts
Primary ContactSung-Soo Park, MD. PhD.
Backup ContactYoung-Woo Jeon, MD. PhD.
Outcome results
None listed