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

BTG

Status and phase: Completed; Phase 1

Conditions: Osteosarcoma; Lymphoma; Leukemia

Treatments: Drug: glucarpidase, high-dose methotrexate, leucovorin; Drug: high-dose methotrexate, leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT00634504

PR001-CLN-pro017

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

A

Experimental group

Description:

High-dose methotrexate, leucovorin, and Voraxaze

Treatment:

Drug: glucarpidase, high-dose methotrexate, leucovorin

B

Active Comparator group

Description:

High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)

Treatment:

Drug: high-dose methotrexate, leucovorin