Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma

Официальное название

A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma

Обзор

To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy

Вмешательства

• Препарат Penpulimab
  Penpulimab + RMA regimen: Rituximab 375 mg/m2 d0 iv Methotrexate (MTX) 3.5g/m2 drip D1 Cytarabine \* (ARA-C) 1-2g/m2 q12H D2-3 iv Penpulimab 200 mg iv D5

Первичные конечные точки

• 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA [Срок оценки: 2 years]

Вторичные конечные точки (1)

• ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients [Срок оценки: 2 years]

Критерии участия

Критерии включения

• For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016
• Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions
• PS score was 0\~4 according to ECOG

Критерии исключения

• Organs or lymph nodes outside the central nervous system are involved
• Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)
• Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription
• Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)
• A severe acute or chronic infection requiring systemic treatment
• The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Shen HR, Wu JZ, Yin H, Du KX, Sibusiso L, Wu YF, Hua W, Li Y, Kong YL, Zhang XY, Gao R, Li JY, Wang L, Liang JH, Xu W. Penpulimab combined with rituximab, high-dose methotrexate, and cytarabine (Pen-RMA) in newly diagnosed primary central nervous system lymphoma (PCNSL): a phase 2 trial. Blood Cancer J. 2026 Feb 11;16(1):23. doi: 10.1038/s41408-026-01450-w. PMID 41672977

Идентификаторы

NCT: NCT05347641 · IRB-GL1-AF03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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