ACTRN12607000347460撤回3 期
A Phase III Study Comparing Low Dose Cyclosporine, Methotrexate And Prednisone Versus Standard Dose Cyclosporine and Methotrexate As Graft Versus Host Disease Prophylaxis In Myeloblative Allogeneic Stem Cell Transplantation (ALLG BM10 trial) in patients with haematological malignancies.(Incorporating an Open-Label Sub-study Investigating The Use Of Valganciclovir In The Prevention Of Cytomegalovirus Infection In Hematopoietic Stem Cell Transplant Recipients in patients with haematological malignancies
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 300 人开始时间: 2007年6月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 60 Years（—）
- 性别
- All
入选标准
- •2. Presence of a haematological malignancy, for which myeloblative allogeneic haematopoietic stem cell transplant is considered appropriate therapy.3. Disease status: acute myeloblastic leukaemia, acute lymphoblastic leukaemia (ALLG), Philadelphia positive ALL in first or later complete remission, chronic myeloid leukaemia (CML), multiple myeloma, non-hodgkin’s lymphoma, Hodgkin’s lymphoma in first or later complete remission, myelodisplastic syndrome. Myelofibrosis and other haematological malignancies are also included. 4. Ability to give informed consent.5. Preserved functional status (Eastern Cooperative Oncology Group performance status <2).6. Left ventricular ejection fraction > 45%. 7. Diffusing capacity of the lung for carbon monoxide > 50% of normal on pulmonary function testing.8. Serum Creatinine <150 umol/L9. Serum Bilirubin < 40mmol/l, AST < 3 x upper limit of normal.10. Availability of a willing, 7/8 or 8/8 human leukocyte antigens (HLA) -matched sibling or unrelated stem cell donor matched at HLA A, B, C and DRB1 (One antigen mismatch at Class I is permissible if no other suitable donor is available).11. Ability to harvest > 2.0 x 106/kg CD34 peripheral blood stem cells.
排除标准
- •1. Human immunodeficiency virus sero-positive2. Life expectancy less than 3 months.3. Psychiatric condition preventing the patient from providing informed consent.4. Pregnant or lactating women.5. History of active malignant disease within the previous 5 years excluding basal cell carcinoma or sqamous cell carcinoma of the skin.6. Previous allogeneic stem cell transplant7. More than 2 previous autografts
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