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临床试验/CTRI/2020/10/028314
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

发起方
Tata Memorial Center

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