CTRI/2023/06/054320尚未招募3 期
Extended aprepitant in control of delayed emesis during induction chemotherapy for acute myeloid leukaemia in children and adolescents aged 5 to 18 years
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
入选标准
- •Patients with a confirmed diagnosis of acute myeloid leukemia
- •Aged 5 to 18 years, with a weight of more than 15 kg.
- •Chemo-naïve
- •Scheduled to receive the first cycle of AML induction chemotherapy
- •Patient or their attendants can understand Hindi or Tamil/English and are willing to participate in the study and for follow-up
排除标准
- •Vomiting, retching, or more than mild nausea within 24 hours before the start of chemotherapy
- •Any history of CNS disease including brain metastasis, seizure disorder, or psychosis
- •Significant organ dysfunction: SGOT/ SGPT >2.5x ULN, S. bilirubin >1.5x ULN, S. creatinine >1.5x ULN
- •Not willing to participate in the study.
- •Need for contraindicated concomitant medication (pimozide, terfenadine, astemizole, or cisapride)
- •Need for medication that strongly induces CYP3A4 activity (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)
- •Patients on steroids for systemic illness
- •Prior aprepitant/ fosaprepitant use.
- •Received radiotherapy to the abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation.
研究者
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