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临床试验/KCT0003049
KCT0003049进行中(未招募)未知

Pilot study of ruxolitinib in relapsed or refractory Hodgkin lymphoma and primary mediastinal large B-cell lymphoma

Samsung Medical Center0 个研究点目标入组 20 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
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 Study

入排标准

年龄范围
19(Year) 至 80(Year)(—)
性别
All

入选标准

  • <Inclusion criteria>
  • 1) Histologically proven Hodgkin lymphoma or primary mediastinal large B-cell lymphoma
  • 2) Patient should belong to any one of following clinical situations
  • A. Patient who are not able to get autologous stem cell transplantation after relapsing the salvage chemotherapy
  • B. Relapsed after autologous stem cell transplantation
  • C. Refractory to salvage chemotherapy or autologous stem cell transplantation
  • 3) Adequate organ function as defined by the following criteria:
  • A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) =2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
  • B. Total serum bilirubin =1.5 x ULN
  • C. Absolute neutrophil count (ANC) = 1500/µL
  • D. Platelets = 100,000/µL
  • E. Hemoglobin = 9.0 g/dL (may be transfused or erythropoietin treated)
  • F. Serum calcium = 12.0 mg/dL
  • G. Serum creatinine = 1.5 x ULN
  • 4) At least one measurable lesion
  • 5) ECOG PS 0-2
  • 6) Informed consent
  • 7) Age from 19 to 80

排除标准

  • <Exclusion criteria>
  • 1) Previously received allogeneic stem cell transplantation
  • 2) History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
  • 3) Currently uncontrolled active infection
  • 4) Previous history of recurrent herpes zoster or recurrent tuberculosis
  • 5) Ongoing cardiac dysrhythmias of NCI CTCAE grade =2.
  • 6) Pregnant or lactating females or patients who are not willing to use an adequate method of birth control for the duration of the study

研究者

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