JPRN-jRCT2080223598已完成Unknown
Extended clinical study of DSP-1958
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 96
研究概览
简要总结
In conclusion, we evaluated the safety of IV thiotepa HDT prior to autologous HSCT for 41 patients with pediatric solid or brain tumors and 51 patients with malignant lymphoma. There were no new safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Collected adequate dose of hematopoietic stem cells.
- •2) Ability to understand and the willingness to sign a written informed consent form.
- •3) Negative pregnancy test.
- •4) Taking appropriate contraceptive measures.
- •5) ECOG PS of 0 to 2.
- •6) Adequate liver function, renal function, and cardiac function.
排除标准
- •1) Receiving any treatment for primary disease.
- •2) Received live attenuated vaccines within 90 days.
- •3) Pregnant or breastfeeding.
- •4) Uncontrolled intercurrent illness.
- •5) Patients who are receiving any other investigational agents.
- •6) Active infection.
- •7) History of allergic reaction attributed to compounds of similar chemical composition.
- •8) HIV Ab positive.
- •9) Planning or received within 14 days to treat hydropericardium, pleural effusion.
- •10) Patients who had grapefruits or grapefruits juice, or St. John's wort within 13 days.
- •11) Unsuitable for the clinical trial
- •12) Unable to receive adequate rehydration and frequent blood transfusion.
- •13) Received hematopoietic transplantation within 6 months.
研究者
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