LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma (NCT03684980)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (51 items) and avoid the listed exclusions (37 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Arms A, B and D:
- Patient with SCNSL requiring treatment for extra-CNS disease are excluded.
- Patient concurrently using other approved or investigational antineoplastic agents.
- Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosoureas or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy. Exceptions are allowed for rituximab and methotrexate for patients enrolling Arm A as long as patients have recovered from side effects.
- Patient has received external beam radiation therapy to the CNS within 28 days of the first dose of the study drug.
- Patient has an active concurrent malignancy requiring active therapy.
- The patient has been treated with radio- or toxin-immunoconjugates within 70 days of the first dose of the study drug.
- Patient weighs \<40kg
- Patient is allergic to components of the study drug.
- Patient is known to have human immunodeficiency virus (HIV) infection.
- Patient is known to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.
- Severe, active medical co-morbidity such as unstable angina and/or congestive heart failure, coronary artery disease, significant abnormalities on electrocardiogram (EKG), uncontrolled or symptomatic arrhythmias or valvular disease; active infection, severe chronic obstructive pulmonary disease or other respiratory illness, hepatic insufficiency, known pre-existing immunodeficiency as seen in organ transplant recipients, renal failure with CrCl \<60 mL/min.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Dana Farber Cancer Institute (Data Collection and Specimen Analysis) — Boston, Massachusetts
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey
- Memorial Sloan Kettering Bergen — Montvale, New Jersey
- Memorial Sloan Kettering Commack — Commack, New York
- Memorial Sloan Kettering Westchester — Harrison, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Nassau — Uniondale, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Cleveland Clinic (Data Collection and Specimen Collection) — Cleveland, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Central Nervous System Lymphoma
- Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies — Houston, Texas
- Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR) — Philadelphia, Pennsylvania
- Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) — Bethesda, Maryland
- A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas — Tampa, Florida
- Acalabrutinib in CNSL — Boston, Massachusetts
Explore by condition: All Central Nervous System Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.