ISRCTN76815071已完成不适用
Risk adapted treatment of Acute Myelocytic Leukaemia (AML)
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 1,105 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •First randomisation:
- •1. Patients with newly diagnosed de novo Acute Myelocytic Leukaemia (AML) (including all cytological subtypes M0-M7)
- •2. Age 15 - 60 years inclusive
- •3. Patients have given informed consent
- •4. Leucocytosis (White Blood Cells [WBC] greater than 30 x 10^9/l) is not an exclusion criterion, but it will require postponement of Granulocyte-Colony Stimulating Factor (G-CSF) administration until WBC have declined to 20 x 10^9/l on chemotherapy
- •Patients after completion of CYCLE II and peripheral blood stem cell collection are eligible for second randomisation if:
- •1. Complete remission continues (marrow cytology and blood evaluation)
- •2. Poor risk status according to criteria of Appendix III
- •3. Not eligible for genotypically Human Leukocyte Antigen (HLA) matched allogeneic Bone Marrow Transplant (BMT)
- •4. Absence of congestive heart failure or pulmonary disease
- •5. Serum bilirubin as parameter of liver function abnormalities not elevated above 3 x normal value
- •6. Number of blood cells collected ('transplant'; PBSCT) being at least 2 x 10^8 nucleated cells/kg or 10 x 10^4 Colony-Forming Units Granulocyte-Macrophage (CFU-GM) per kg or 2 x 10^6 CD34-positive cells per kg. In case of no or insufficient PBSCT, an adequate autologous marrow graft must have been collected
- •7. Performance status of World Health Organization (WHO) grade 0, 1 or 2 at time of randomisation
- •8. Informed consent
排除标准
- •First randomisation:
- •1. Patients with a concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma
- •2. Patients previously treated with chemotherapy
- •3. Leukaemia following from a documented myelodysplasia with a duration of more than 6 months
- •4. Blastic crisis of chronic myeloid leukaemia or leukaemia developing from myeloproliferative diseases (e.g. polycythemia vera, myelofibrosis)
- •5. Renal or liver function abnormalities i.e. creatinine and bilirubin of more than 3 x normal value, except if directly attributable to the leukaemia (high serum lysosymes, hyperuricemia, leukaemic cell infiltration)
- •6. Human Immunodeficiency Virus (HIV) positive serology
- •7. Patients with severe cardiac, pulmonary or neurologic disease
- •8. Pregnancy
研究者
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