CTRI/2020/10/028314招募中2 期
A phase II Study of Methotrexate, Lenalidomide and Rituximab Induction in Newly Diagnosed Primary CNS Lymphoma
Tata Memorial Center0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Patients with histologically proven PCNSL
- •Age > 18 years
- •ECOG PS <4
- •At least one bi-dimensionally measurable target lesion on MRI
- •Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3
- •Adequate liver function with Serum SGOT/AST or SGPT/ALT < 3.0 X Upper Limit of Normal ULN ; bilirubin < 1.5 X LNS
- •Creatinine clearance more than 60 ml/min
- •Men and women of child bearing age should agree to use reliable contraceptive
- •Neuropathy of >= grade 2 severity
排除标准
- •HIV infection
- •Prior history of organ transplantation or other cause of severe immunodeficiency
- •History of heart disease and/or impaired cardiac function (ECG QTc >450msec, congenital long QT syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure nyha iii/iv, uncontrolled hypertension)
- •Pregnancy or breast feeding Hypersensitivity to lenalidomide
- •Active hepatitis B and C
- •Prior history of malignancies within 3 years
研究者
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