Feasibility of an oral hydration regimen post high-dose methotrexate in children with acute leukemia: a pilot study.
[BACKGROUND] Administration of high-dose methotrexate(HDMTX) requires strict intravenous hydration contributing to lengthy hospital stays.
APA
Karri PS, Sidhique Pr R, et al. (2026). Feasibility of an oral hydration regimen post high-dose methotrexate in children with acute leukemia: a pilot study.. Discover oncology, 17(1). https://doi.org/10.1007/s12672-026-04608-x
MLA
Karri PS, et al.. "Feasibility of an oral hydration regimen post high-dose methotrexate in children with acute leukemia: a pilot study.." Discover oncology, vol. 17, no. 1, 2026.
PMID
41661503
Abstract
[BACKGROUND] Administration of high-dose methotrexate(HDMTX) requires strict intravenous hydration contributing to lengthy hospital stays. Transition to oral hydration regimen(OHR) after ensuring adequate methotrexate(MTX) clearance could decrease duration of hospitalization.
[PURPOSE] The primary objective was to assess the feasibility of administration of OHR post HDMTX infusion in an in-hospital setting by evaluating the proportion of HDMTX courses completed on OHR.
[METHODS] This was a prospective, single-centre pilot study. Children with acute lymphoblastic leukemia/lymphoma aged 5-18years, treated on IciCLe-ALL-14 protocol were eligible. Following mandatory intravenous hydration phase and 24 h MTX level < 150micromol/L, children were started on OHR that included: (i) oral fluids, (ii) oral bicarbonate (650 mg/m2/dose q6h, tablet strength 500 mg) (iii) oral leucovorin(as per IciCLe-ALL-14 protocol, tablet strength 15 mg). Oral fluid intake and urine output were documented by parents, adherence was monitored periodically by nurses. 42 h MTX levels were measured. To ensure safety, children were changed to intravenous hydration if pre-defined clinical and laboratory withdrawal criteria were met.
[RESULTS] A total of 22 HDMTX courses of 13 participants were enrolled and 20 out of 22 (90.9%) HDMTX courses were completed on OHR. All, but two withdrawn courses, had a 42 h methotrexate < 1.0µmol/L. Withdrawals were due to inadequate urinary alkalinization with oral bicarbonate. Median oral hydration rate was 146.08ml/m/h (Interquartile range, 60.01) against a minimum requirement of 125ml/m/hr. No grade ¾ renal toxicity was observed. All courses with grade ½ vomiting achieved the required oral hydration rate and urine output. The median duration of oral hydration(OH) was 25 h (Interquartile range, 2) in the in-patient setting.
[CONCLUSION] OHR post HDMTX infusion is feasible in an in-patient setting in pediatric population with acute lymphoblastic leukemia/lymphoma. Early identification of criteria warranting withdrawal from OHR and reinstitution of intravenous hydration helps in mitigating severe effects of toxicity. The length of hospitalisation of a HDMTX course could be cut short by a duration of 25 h if implemented on outpatient basis. The study was approved by the Institute Ethics Committee of All India Institute of Medical Sciences, New Delhi (IECPG-542/23.09.2021, RT-23/25.11.2021, OT-06/07.06.2023) and registered under Clinical Trials Registry – India (CTRI/2022/02/040229 dated 11.02.2022).
[SUPPLEMENTARY INFORMATION] The online version contains supplementary material available at 10.1007/s12672-026-04608-x.
[PURPOSE] The primary objective was to assess the feasibility of administration of OHR post HDMTX infusion in an in-hospital setting by evaluating the proportion of HDMTX courses completed on OHR.
[METHODS] This was a prospective, single-centre pilot study. Children with acute lymphoblastic leukemia/lymphoma aged 5-18years, treated on IciCLe-ALL-14 protocol were eligible. Following mandatory intravenous hydration phase and 24 h MTX level < 150micromol/L, children were started on OHR that included: (i) oral fluids, (ii) oral bicarbonate (650 mg/m2/dose q6h, tablet strength 500 mg) (iii) oral leucovorin(as per IciCLe-ALL-14 protocol, tablet strength 15 mg). Oral fluid intake and urine output were documented by parents, adherence was monitored periodically by nurses. 42 h MTX levels were measured. To ensure safety, children were changed to intravenous hydration if pre-defined clinical and laboratory withdrawal criteria were met.
[RESULTS] A total of 22 HDMTX courses of 13 participants were enrolled and 20 out of 22 (90.9%) HDMTX courses were completed on OHR. All, but two withdrawn courses, had a 42 h methotrexate < 1.0µmol/L. Withdrawals were due to inadequate urinary alkalinization with oral bicarbonate. Median oral hydration rate was 146.08ml/m/h (Interquartile range, 60.01) against a minimum requirement of 125ml/m/hr. No grade ¾ renal toxicity was observed. All courses with grade ½ vomiting achieved the required oral hydration rate and urine output. The median duration of oral hydration(OH) was 25 h (Interquartile range, 2) in the in-patient setting.
[CONCLUSION] OHR post HDMTX infusion is feasible in an in-patient setting in pediatric population with acute lymphoblastic leukemia/lymphoma. Early identification of criteria warranting withdrawal from OHR and reinstitution of intravenous hydration helps in mitigating severe effects of toxicity. The length of hospitalisation of a HDMTX course could be cut short by a duration of 25 h if implemented on outpatient basis. The study was approved by the Institute Ethics Committee of All India Institute of Medical Sciences, New Delhi (IECPG-542/23.09.2021, RT-23/25.11.2021, OT-06/07.06.2023) and registered under Clinical Trials Registry – India (CTRI/2022/02/040229 dated 11.02.2022).
[SUPPLEMENTARY INFORMATION] The online version contains supplementary material available at 10.1007/s12672-026-04608-x.