Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma

PHASE1UnknownINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 15, 2022

Primary Completion Date

January 31, 2025

Study Completion Date

July 31, 2025

Conditions
Primary Central Nervous System Lymphoma
Interventions
DRUG

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)

DRUG

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

Trial Locations (1)

75013

RECRUITING

Hôpital Pitié-Salpêtrière, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BTG International Inc.

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT05135858 - Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma | Biotech Hunter | Biotech Hunter