Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
研究概览
简要总结
This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.
详细描述
PRIMARY OBJECTIVES:
I. Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy.
SECONDARY OBJECTIVES:
I. Compare the costs incurred by patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.
II. Compare resource utilization (transfusions, etc.) in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after blood count recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (promyelocytic leukemia [PML]/retinoic acid receptor [RAR]), or variants according to the 2008 World Health Organization (WHO) classification
- •Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is planned to start such therapy within 1 week
- •Provide signed written informed consent
- •Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or subsequent salvage therapy)
排除标准
- •Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials
研究组 & 干预措施
Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
干预措施: standard follow-up care (Procedure)
Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
干预措施: medical chart review (Other)
Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
时间窗: Up to day 35
A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.
次要结局
未报告次要终点