NL-OMON50953撤回不适用
Enhancement of immune response by combining immune checkpoint blockade and radiation in patients with recurrent / refractory malignant lymphoma (re-directing the immune system). - RIMAL1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- patients with refractory / recurrent malignant lymphoma eligible for ICB
- •- aged 18 - 75 year
- •- WHO score >=2
- •- adequate organ function
- •neutrophil count
- •serum creatinine
- •- no prior treatment with checkpoint inhibitors
- •- no non-infectious pneumonitis requiring steroids
- •- not pregnant
- •- patients of childbearing/reproductive potential should use 2 birth control
- •- written informed consent
排除标准
- •- 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.
- •- Sensory or motor peripheral neuropathy > grade 2.
研究者
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