Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

BTG International Inc.20 enrolled

Overview

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteosarcoma Leukemia Lymphoma

Interventions

glucarpidase, high-dose methotrexate, leucovorinDRUG

single intravenous dose

high-dose methotrexate, leucovorinDRUG

standard of care, leucovorin every 6 hours

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination * Require intravenous leucovorin Exclusion Criteria: * Arm A only: allergic reactions to lactose * Arm A only: hereditary fructose or galactose intolerance * Arm B only: delayed elimination of MTX

Locations (25)

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of Leucovorin

Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.

Time frame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration

Data from ClinicalTrials.gov

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