Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Официальное название

An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Обзор

This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.

Подробное описание

Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab \[a programmed cell death 1 (PD-1) inhibitor\] for recurrent patients with primary CNS lymphoma.

Вмешательства

• Препарат Camrelizumab
  Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.

Первичные конечные точки

• ORR(objective response rate) [Срок оценки: Up to three years]

Вторичные конечные точки (5)

• The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease) [Срок оценки: Up to three years]
• PFS(progression free survival) [Срок оценки: Up to three years]
• OS(overall survival) [Срок оценки: Up to three years]
• ADEs( adverse events) [Срок оценки: Up to three years]
• KPS(Karnofsky Performance Status) [Срок оценки: Up to three years]

Критерии участия

Критерии включения

• The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
• Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
• Measurable focus in MRI (>10x10mm);
• Aged > 18 years;
• Life expectancy of at least 12 weeks;
• The patient has a Karnofsky performance status of at least 50%;
• Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells>3.0×10\^9/L;platelet>80×10\^9/L;hemoglobin>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
• Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
• The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;

Критерии исключения

• Concurrent administration of any other antitumor therapy；
• Allergic to the ingredients of research drugs；
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
• Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
• Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
• Active infection;
• Risk of bleeding;
• HIV positivity;
• Pregnancy and lactation;

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

• Sanbo Brain Hospital Capital Medical University — Пекин

Идентификаторы

NCT: NCT04070040 · 1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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