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An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Phase 1
Not Enrolling
Osteosarcoma, Leukemia, Lymphoma

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Trial Information

An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics (PK) of leucovorin

Outcome Time Frame:

Up to 3 hours after leucovorin

Safety Issue:


Principal Investigator

Andrew Saunders, MD

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

August 2009

Related Keywords:

  • Osteosarcoma
  • Leukemia
  • Lymphoma
  • high dose methotrexate
  • Voraxaze
  • leucovorin
  • delayed elimination
  • methotrexate toxicity
  • rescue
  • renal insufficiency
  • Leukemia
  • Lymphoma
  • Osteosarcoma



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