Feasibility of an oral supportive care regimen during high dose methotrexate administration in children with hematolymphoid malignancies - A single arm interventional pilot study

Dr Aditya Kumar Gupta0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

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•Established diagnosis of hematolymphoid malignancy (acute lymphoblastic leukemia, Non-Hodgkin lymphoma) - primary or relapsed disease
•On chemotherapy protocol requiring high dose methotrexate (HDMTX) (>=1g/m2/dose)
•Eligible for HDMTX administration as per unit protocol and chemotherapy protocol
•Atleast one previous course of HDMTX uneventfully administered with intravenous alkaline hydration.

•Prior to start of HDMTX:
•MTX toxicity during previous courses of HDMTX.
•Requirement of intravenous hydration or intravenous alkalinization for any other reason (e.g. concurrent chemotherapy requiring intravenous hydration)
•After the MTXT1:
•Unsafe MTXT1
•Clinical features of MTX toxicity
•Nausea - Grade 3 and above
•Vomiting - Grade 3 and above
•Oral mucositis - Any grade
•Fever - temperature > 100.4 F
•Contraindication to enteral feeds e.g. ileus
•Withdrawal criteria (after enrolment):
•Failure to place NG tube due to patient denial or uncooperative child when IARTa is <40% or IARTb is <40% or IARTc is <85% or IARTd is <85%.
•Unsafe MTXT2
•Nausea - Grade 3 and above
•Vomiting - Grade 3 and above
•Oral mucositis - Any grade
•Fever - temperature > 100.4 F
•Contraindication to enteral feeds e.g. ileus, neutropenic enterocolitis
•Requirement of more than 2 bolus doses of oral sodium bicarbonate to maintain target urine pH of 7.0 â?? 8.0
•Urine output measured from time point p to time point c is <2ml/kg/hr.
•Failed repeat oral dose of sodium bicarbonate or leucovorin 20 minutes after a vomited dose.
•More than 2 episodes of vomited oral sodium bicarbonate or leucovorin

发起方

Dr Aditya Kumar Gupta