18
Participants
Start Date
September 15, 2022
Primary Completion Date
January 31, 2025
Study Completion Date
July 31, 2025
Glucarpidase
Glucarpidase (CPG2) Dose: 2000 U (2 vials of 1000 U per dose) 5 minutes-intravenous administration 24 hours after each Methotrexate infusion (i.e. 6 times in the whole protocol)
Methotrexate (MTX)
MTX will be administred 6 times during the protocol, at a variable interval of 8, 6 or 5 days. It will be administrated in a 2 to 3-hour IV infusion, at the dose of 3.5 g/m2 (body surface area capped at 2 m2). Each MTX administration will be preceded by a prehydration and will be followed by a posthydration
RECRUITING
Hôpital Pitié-Salpêtrière, Paris
Collaborators (1)
BTG International Inc.
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER