Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma

Официальное название

A Single-Arm, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma

Обзор

The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma.

Вмешательства

• Препарат Axicabtagene Ciloleucel
  A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Первичные конечные точки

• Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators [Срок оценки: Up to 2 years]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators [Срок оценки: Up to 2 years]
• Complete Metabolic Response (CMR) - determined by investigator [Срок оценки: 3 months from axi-cel infusion]
• Duration of Response (DOR) Per the Lugano Classification [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]
• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAE) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Histologically confirmed LBCL (Large B-Cell Lymphoma) according to the WHO 2016 classification, including the following subtypes:DLBCL-NOS (Diffuse Large B-Cell Lymphoma, Not Otherwise Specified),HGBL (High-Grade B-Cell Lymphoma, including HGBL with MYC, BCL-2, and/or BCL-6 rearrangements (DHL/THL), HGBL-NOS),DLBCL transformed from follicular or marginal zone lymphoma, eligible if the patient has not previously received anthracycline-containing therapy
• International Prognostic Index (IPI) score of 2-5 at initial diagnosis.
• Individuals must have a positive interim positron emission tomography (PET) (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy or high-risk ctDNA status (ctDNA levels not reduced by at least 2-log after two cycles of R-chemotherapy)
• Age of 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Adequate renal, hepatic, pulmonary, and cardiac function, defined as:

• Creatinine clearance (estimated by Cockcroft-Gault formula) ≥ 60 mL/min
• Serum ALT/AST ≤ 2.5 × Upper Limit of Normal (ULN)
• Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert's syndrome)
• Left ventricular ejection fraction ≥ 50%, no pericardial effusion as determined by echocardiography, and no clinically significant arrhythmias No clinically significant pleural effusion
• Baseline peripheral oxygen saturation > 92% under room air ventilation
• At least one measurable lesion.
• For women of childbearing potential, a negative serum pregnancy test is required (women who have undergone surgical sterilization or are postmenopausal for at least 2 years are considered not to be of childbearing potential).

Критерии исключения

• According to the WHO 2016 classification, patients with the following subtypes are excluded:

• LBCL with T-cell/histiocyte-rich background
• Primary central nervous system DLBCL
• PMBCL (Primary Mediastinal B-Cell Lymphoma)
• B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical HL (Hodgkin Lymphoma)
• Burkitt lymphoma
• History of Richter transformation in chronic lymphocytic leukemia
• Presence of detectable malignant cells in the CSF (cerebrospinal fluid), brain metastases, or history of central nervous system involvement by lymphoma.

Presence of cardiac involvement by lymphoma.

• Prior treatment for LBCL other than two cycles of R-chemotherapy.
• History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
• Presence of central nervous system disorders: history of stroke, transient ischemic attack, or reversible posterior leukoencephalopathy syndrome (PRES) within 12 months prior to enrollment.
• History of acute or chronic active hepatitis B or C infection, unless HBV-DNA and HCV-RNA levels are below the level of detection.
• Human immunodeficiency virus (HIV) positivity, unless on appropriate antiretroviral therapy with undetectable viral load by PCR and a CD4 count > 200 cells/µL.
• Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.
• History of clinically significant cardiac disease within 12 months prior to enrollment.
• Any other condition deemed by the investigator as unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China — Шанхай

Идентификаторы

NCT: NCT06935136 · RJ-1L HR-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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