Enhancement of immune response by combining immune checkpoint blockade and radiation in patients withrecurrent / refractory malignant lymphoma (re-directing the immune system). - RIMAL1

Radboud University Medical Centre0 个研究点目标入组 20 人开始时间: 2021年4月8日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•- patients with refractory / recurrent malignant lymphoma eligible for ICB therapy
•- aged 18 – 75 year
•- WHO score =2
•- adequate organ function: neutrophil count, serum creatinine, ASAT, ALAT, albumin
•- no prior treatment with checkpoint inhibitors
•- no non-infectious pneumonitis requiring steroids
•- not pregnant
•- patients of childbearing/reproductive potential should use 2 birth control methods
•- written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Not fit (mentally or physically) to undergo the proposed treatment.
•- Patients with connective tissue diseases (inflammatory myopathy (polymyositis and ermatomyositis), systemic lupus erythematosus, Sjögren syndrome, systemic sclerosis, antisynthetase syndrome, rheumatoid arthritis, severe psoriasis and mixed CTDs), vasculitis (granulomatosis with polyangiitis (Wegener’s granulomatosis), microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (Churg–Strauss syndrome), severe Behçet disease, Takayasu arteritis, giant cell arteritis, Buerger disease, Kawasaki disease, polyarteritis nodosa, severe immunoglobulin A (IgA) vasculitis (Henoch–Schönlein purpura), severe cutaneous vasculitis, polymyalgia rheumatica, severe cryoglobulinaemia and undifferentiated systemic vasculitis) and other autoimmune diseases (primary biliary cirrhosis, severe autoimmune hepatitis, multiple sclerosis, severe antiphospholipid syndrome, myasthenia gravis, Guillain–Barré syndrome, inflammatory bowel disease, Miller–Fisher syndrome, Vogt–Koyanagi–Harada syndrome, eosinophilic fasciitis (Shulman syndrome), relapsing polychondritis and severe autoinflammatory diseases) ( Martins et al. 2019).
•- Sensory or motor peripheral neuropathy > grade 2.

发起方

Radboud University Medical Centre