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临床试验/KCT0005626
KCT0005626尚未招募未知

Multicenter, investigator initiated trial, investigating the efficacy and safety of IV-immunoglobulin therapy in elderly patients with diffuse large B cell lymphoma treated with R-CHOP

Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 158 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
158

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
65(Year) 至 74(Year)(—)
性别
All

入选标准

  • 1. Untreated, newly diagnosed with diffuse large B cell lymphoma
  • 2. Patients who understand and agree with this study protocol
  • 3. Patients who can follow instructions and study protocol
  • 4. Age between 65 to 74 years old, male and female
  • 5. Ann arbor stage II, III or IV
  • 6. Patients who can receive standard R-CHOP chemotherapy
  • 7. ECOG PS 0, 1 or 2

排除标准

  • 1. Clinically significant uncontrolled systemic disease
  • 2. Treatment history of immunotherapy or other chemotherapy for diffuse large B cell lymphoma, except corticosteroid less than 8days
  • 3. Ann arbor stage I
  • 5. Treatment history of radiotherapy for diffuse large B cell lymphoma
  • 6. Central nervous system involvement
  • 7. Patients who can not receive R-CHOP therapy
  • 8. Known history of infection with HIV
  • 9. Absolute neutrophil count < 1,500/mm3
  • 10. Platelet count < 75,000/mm3
  • 11. Serum creatinine = 2.0 mg/dl or GFR < 50 mL/min
  • 12. Serum bilirubin = 2 x upper limit of normal (ULN)
  • 13. SGOT/AST or SGPT/ALT = 3 x ULN
  • 14. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid carcinoma, or other cancer from which the subject has been disease free for over 5 years or which will not limit survival to less than 5 years
  • 15.MUGA scan or TTE Ejection fraction < 45%
  • 16. Treatment history with doxorubicin over 200mg/m2
  • 17. Concurrent participation in another therapeutic clinical trial

研究者

发起方
Chonnam National University Hospital Hwasun Hospital

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