Extended aprepitant in control of delayed emesis during induction chemotherapy for acute myeloid leukaemia (AML) A multicentric investigator initiated open label randomised parallel group superiority trial to investigate the efficacy of extended dosing aprepitant in control of chemotherapy induced delayed nausea-vomiting during induction chemotherapy for acute myeloid leukaemia - EACODE AM

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

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•Patients with confirmed diagnosis of acute myeloid leukaemia
•Age more than or equal to 18 years, with weight more than or equal to 30 kg
•Chemo-naÃ¯ve
•Scheduled to receive first cycle of AML induction chemotherapy 3 days of daunorubicin at 60 mg/m2 and 7 days of cytosine arabinoside infusion @ 100 mg/m2 24-hour infusion.
•Patient or their attendants can understand Hindi /Tamil/English, and are willing for participation in the study and for follow-up

•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 or SGPT more than 2.5 times ULN, S. bilirubin more than 1.5 times ULN, S. creatinine more than 1.5times 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 systemic steroids other than for use as an antiemetic agent
•Prior aprepitant or fosaprepitant use.
•Received radiotherapy to abdomen, pelvis, cranium, or craniospinal regions, in the week prior to treatment initiation

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