High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response to Induction Chemotherapy (CR or PR)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
- •Patients must have t-MDS/t-AML
- •To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
- •Patients must be over the age of
- •Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.
排除标准
- •Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
- •Psychiatric condition which would prevent compliance or possibly be worsened by treatment
研究组 & 干预措施
Induction chemotherapy followed by stem cell transplant
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
干预措施: Ara-C (Drug)
Induction chemotherapy followed by stem cell transplant
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
干预措施: Mitoxantrone (Drug)
Induction chemotherapy followed by stem cell transplant
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
干预措施: Etoposide (Drug)
结局指标
主要结局
Response to Induction Chemotherapy (CR or PR)
时间窗: Day 28-40
Complete remission (CR): \<5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): \>5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Overall Survival
时间窗: Up to 2000 days
Relapse-free Survival
时间窗: Up to 2000 days
Relapse is defined as bone marrow blasts \>5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
次要结局
- Feasibility of Stem Cell Collection(1-5 days from initiation of stem cell collection)
- Numbers of Stem Cells Collected(1-5 days from initiation of stem cell collection)
- Overall Survival in Patients Undergoing Autologous Stem Cell Transplant(Up to 817 days)
- Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant(Up to 883 days)