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
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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