JPRN-UMIN000001141已完成1 期
Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia. - Phase I Study of GO+Ara-C+DNR for Relapsed or Refractory Patients with Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
Three patients in the IAG regimen who were administered 5 mg/m(2) GO showed DLT. No patients had veno-occlusive disease or sinusoidal obstructive syndrome. In conclusion, 3 mg/m(2) GO combined with Ara-C and IDR or DNR can be safely administered, and phase II trials should be conducted to investigate the clinical efficacy of the combination therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. History of MDS or MPD 2. Secondary AML related to chemotherapy or radiotherapy 3. CNS-leukemia 4. History of hematopoietic stem cell transplantation 5. Total dose of DNR >500 mg/m2 6. Pregnant and/or lactating woman 7. History of therapy with anti-CD33 monoclonal antibody 8. Complication of active malignant disease 9. Uncontrolled infection 10.Positive HBV, HCV and HIV infection 11.History of attending any phase study of new drugs. 12.If physisians disagree to attend this study
研究者
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