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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2023-00216446 | Other Grant/Funding Number | Ministry of Food and Drug Safety |
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| Name | Class |
|---|---|
| Yeouido St. Mary's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced immunochemotherapy | Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate |
| |
| Classical Immunochemotherapy | Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T Therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Soo Park, MD. PhD. | Contact | +82-02-2258-6754 | sspark@catholic.ac.kr | |
| Young-Woo Jeon, MD. PhD. | Contact | +82-10-2691-4067 | native47@catholic.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary Hospital | Recruiting | Seoul | 06591 | South Korea |
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Blood serum, Bone marrow
| Bispecific antibody | Drug | 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. |
|
| Antibody-Drug Conjugate | Drug | 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 antibody | Drug | 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. |
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| Proteasome Inhibitor | Drug | 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. |
|
| IMiD treatment | Drug | 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. |
|
| Yeoido St. Mary Hospital | Recruiting | Seoul | 07345 | South Korea |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| D018033 | Antibodies, Bispecific |
| D018796 | Immunoconjugates |
| D000911 | Antibodies, Monoclonal |
| D061988 | Proteasome Inhibitors |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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