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

No results posted yet for this study

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

Rituximab

Patients will be treated with rituximab 500 mg/m\^2.

DRUG

leucovorin

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684980 on ClinicalTrials.gov