drugset / Trial / NCT03684980
LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
Phase 0
Active not recruiting
58 enrolled
Memorial Sloan Kettering Cancer Center
University of Alabama at Birmingham · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL.
Timeline
- Start
- 2018-11-14
- Primary completion
- 2027-11
- Completion
- 2027-11
Publications
- Schaff LR, Carlow D, Schofield R, Wongchai V, Madzsar J, Hyde A, Reiner AS, Panageas KS, DeAngelis LM, Mellinghoff IK, Lobbous M, Nabors LB, Grommes C. Low-Dose Planned Glucarpidase Allows Safe Outpatient High-Dose Methotrexate Treatment for CNS Lymphoma. JCO Oncol Pract. 2024 Oct;20(10):1384-1390. doi: 10.1200/OP.24.00080. Epub 2024 Jun 25.
- Schaff LR, Lobbous M, Carlow D, Schofield R, Gavrilovic IT, Miller AM, Stone JB, Piotrowski AF, Sener U, Skakodub A, Acosta EP, Ryan KJ, Mellinghoff IK, DeAngelis LM, Nabors LB, Grommes C. Routine use of low-dose glucarpidase following high-dose methotrexate in adult patients with CNS lymphoma: an open-label, multi-center phase I study. BMC Cancer. 2022 Jan 13;22(1):60. doi: 10.1186/s12885-021-09164-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glucarpidase | Protein / enzyme biologic | 1000 iu | — |
| Subject | Glucarpidase | Protein / enzyme biologic | 2000 iu | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Methotrexate | Small molecule | 3000 mg/m2 | — |
| Background | Methotrexate | Small molecule | 3500 mg/m2 | — |
| Background | Methotrexate | Small molecule | 8000 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 500 mg/m2 | — |