Study design and participants
toxicity, renal failure, overdose, cytopenia
RENAL FAILURE, RECRUITMENT, CYTOPENIA
FLIMT (Folinic acid/Leucovorin In Methotrexate Toxicity) was a single-center, open-label, pragmatic randomized controlled trial that compared two doses of intravenous leucovorin in severe low-dose methotrexate toxicity. It was conducted from 9 February 2019 to 1 January 2022 in a single-center tertiary-care teaching hospital in North India. The study was approved by the Institutional Ethics Committee of Postgraduate Institute of Medical Education and Research. A written consent was taken from the patients included in the study. The trial was prospectively registered at the Clinical trial registry of India, a primary Register of the International Clinical Trials Registry Platform (ICTRP). Registration number: CTRI/2019/09/021152.Patients being treated with low-dose methotrexate (≤ 50 mg per week) for any indication who were between the age of 12 to 90 years and had developed severe methotrexate toxicity due to either inadvertent overdose or renal failure (or unknown cause), were eligible to be recruited into the study. Severe toxicity was defined as presence of at least one severe cytopenia (either WBC ≤ 2 × 10^9/L or platelet ≤ 50 × 10^9/L). At enrolment, the patients must not have received more than four leucovorin doses. It was planned to recruit 60 patients, but due to slow recruitment, it was terminated when 38 participants had been recruited.