LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
NCT03684980 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2026-04-15
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.
Conditions
- Central Nervous System Lymphoma
Interventions
- DRUG
-
Methotrexate
(Cohort A) will receive MTX 3 g/m2 or (Cohort B) will receive MTX 8 g/m\^2 (Cohort E) will receive MTX ≤ 3.5 g/ m2
- DRUG
-
Patients will be treated with rituximab 500 mg/m\^2.
- DRUG
-
Patients will also receive standard of care leucovorin rescue starting at least 24 hours after MTX and 2 hours after Voraxaze. Cycles will be 14 days long.
- DRUG
-
Glucarpidase
Glucarpidase 2000 units. Arm E 1000 units.
Sponsors & Collaborators
-
University of Alabama at Birmingham
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Lauren Schaff, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-14
- Primary Completion
- 2027-11-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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