Aprepitant- and Olanzapine- Containing Regimens for Prevention of Acute and Delayed Nausea and Vomiting Associated With High Dose Melphalan and BEAM in Autologous Stem Cell Transplant Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Complete Response (CR)
研究概览
简要总结
The purpose of this study is to help answer the following research question:
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Whether administration of an aprepitant containing regimen, an olanzapine containing regimen or regimen containing both will prevent nausea and vomiting better for patients undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these medications are approved by the United States Food and Drug Administration (FDA) for nausea and vomiting.
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Participants will be randomly assigned to one of the 3 treatment groups:
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Arm A: aprepitant containing anti-emetic therapy
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Arm B: olanzapine containing anti-emetic therapy
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Arm C: Aprepitant plus olanzapine containing anti-emetic therapy
详细描述
This is a multi-center, randomized, non-inferiority phase 3 study conducted to determine an appropriate anti-emetic regimen for patients receiving melphalan for an autologous stem cell transplant (SCT). Candidates for this trial will include patients aged 18-80 years with hematologic malignancies receiving high dose melphalan as part of a conditioning regimen for an autologous stem cell transplant. Patients will be enrolled in 3 arms. Patients in Arm A will receive an aprepitant containing anti-emetic regimen. Patients in Arm B will receive an olanzapine containing anti-emetic regimen. Patients in Arm C will receive an aprepitant plus olanzapine containing anti-emetic regimen. Patients must be able to tolerate oral medications.
Patients will be carefully monitored for rates of emesis, nausea, and mucositis. Any adverse events will be recorded. Impact on quality of life will also be assessed. A total of 184 patients will be accrued to each arm. It is anticipated that the accrual period will last approximately 2-3 years. The primary endpoint of this study is a complete response, defined as no emesis and no rescue therapy within 120 hours of melphalan administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autologous transplant containing high dose melphalan as part of the conditioning regimen (single or 2 day melphalan; BEAM [carmustine, etoposide, cytarabine, melphalan])
- •able to tolerate oral medications
排除标准
- •Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy
- •Any anti-emetic treatment within 24 hours before planned high dose conditioning chemotherapy
- •Pregnancy
- •Baseline corrected QT interval (QTc) > 500 ms
- •History of seizures
- •History of central nervous system (CNS) disease
- •Human immunodeficiency virus (HIV)
研究组 & 干预措施
Aprepitant
aprepitant plus standard anti-emetic regimen
干预措施: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1 (Drug)
Olanzapine
olanzapine plus standard anti-emetic regimen
干预措施: Olanzapine10 mg orally daily on Days -1,0,+1 and +2 (Drug)
Aprepitant plus olanzapine
aprepitant and olanzapine plus standard anti-emetic regimen
干预措施: Aprepitant plus Olanzapine (Drug)
结局指标
主要结局
Complete Response (CR)
时间窗: within 120 hours following melphalan administration; no emesis and no rescue therapy within 120 hours of melphalan administration (within 120 hours following last day of melphalan administration at baseline)
no emesis and no rescue anti-emetic therapy
次要结局
- Delayed Complete Response(25-120 hours post-transplant)
- Acute Complete Response(0 (transplant time) to 24 hours post-transplant)