Immunotherapy in Lymphoma

Официальное название

Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed/Refractory Lymphoma Patients

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Overall survival [Срок оценки: From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.]

Вторичные конечные точки (1)

• Progression-free survival [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

South Korea · 2 центра

• Seoul St. Mary Hospital — Seoul
• Yeoido St. Mary Hospital — Seoul

Идентификаторы

NCT: NCT06796517 · XC24OIDI0042 · RS-2023-00216446

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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