Clinical trial · Interventional
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
NCT00634504CI-TRIAL-00058905LVPKcompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glucarpidase, high-dose methotrexate, leucovorin | Drug | — | UNRESOLVED |
| high-dose methotrexate, leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- High-dose methotrexate, leucovorin, and Voraxaze
- interventionNames
- Drug: glucarpidase, high-dose methotrexate, leucovorin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
- interventionNames
- Drug: high-dose methotrexate, leucovorin
Primary outcomes (1)
- measure
- Pharmacokinetics (PK) of Leucovorin
- timeFrame
- 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.