Pembrolizumab in progressive multifocal leukoencephalopathy (PML) in immunocompromised patients without HIV infection (PENALTY) - APHP211001

Assistance Publique Hopitaux De Paris0 个研究点目标入组 33 人开始时间: 2023年8月9日最近更新: 2024年7月22日

适应症

试验速览

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•1.Age = 18 years old, 2.Diagnosis of definite PML since less than 2 months according to American Academy of Neurology, 3.Presence of JCV in the CSF in the last CSF sampling., 4.Signed informed consent (from the patient, or if unable to consent, from a surrogate), 5. For women of childbearing potential: negative serum or urine b-HCG test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment)

•1.Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases), 10.Patient without national health insurance, and patient on AME (state medical aid), 11.Patient under guardianship or curatorship, 12.Patient deprived of their liberty by a judicial or administrative decision, 2.Patients who have received solid organ transplantation, 3.Hypersensitivity to the active substance or to any of the excipients, 4.Life expectancy less than 1 month, 5.Pregnancy or lactating women or planning birth during the study period, 6.Having previously been treated by anti-PD1mAb, 7.Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion, 8.Patient whose weight is > 100kg, 9.Participation in other interventional study [a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if: -the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study -if this does not alter the study's ability to evaluate the effect of Pembrolizumab in terms of safety and efficacy (from the investigator's point of view)]

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