LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma

Running, not enrolling · Early Phase 1

Conditions studied: Central Nervous System Lymphoma

In brief

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.

Key facts

Study ID

NCT03684980

Run by

Memorial Sloan Kettering Cancer Center

People needed

58

Starts

2018-11-14

Expected to finish

2027-11-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Arm A:
• Histologically documented B-cell non-Hodgkin"s lymphoma involving the brain, spinal cord, and/or leptomeningeal space.
• °Patients in whom the type of lymphoma could not be determined or is unknown (e.g., not enough tissue for further analysis) are assumed to have a B cell lymphoma and are eligible
• Patients with parenchymal lesions must have received no more than two cycles of treatment for treatment of CNS lymphoma or have unequivocal evidence of disease progression on imaging (MRI of the brain/spine or CT head) 28 days prior to study registration. For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings must be consistent with CSF disease 28 days prior to study registration (at the discretion of the investigator).
• Patients who have already received two doses of treatment of CNS lymphoma are eligible for enrollment.
• (Arm A only) as long as they are planned for at least 6 additional doses of methotrexate. Patients must not have evidence of systemic non-Hodgkin lymphoma requiring active treatment.
• Men and woman must be at least 18 years of age on the day of consenting to the study.
• Patients must have a Karnofsky Performance Status (KPS) ≥ 50 (See Appendix 2).
• Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
• Patients must have adequate bone marrow and organ function shown by:
• Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L;
• Platelets ≥ 100 x 10\^9/L and no platelet transfusion within the past 28 days prior to study registration;
• Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cells (RBC) transfusion within the past 28 days prior to study registration;
• International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal;
• Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome;
• CrCl ≥ 60 mL/min using the Cockcroft-Gault equation. Men: CrCl (min/mL) = (140-age) X (actual weight in kg) / 72 X serum creatinine (mg/dL) Women: CrCl (mL/min) = (140-age) X (actual weight in kg) X 0.85 / 72 X serum creatinine (mg/dL)
• Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose.
• Female subjects of childbearing potential must have a negative plasma pregnancy test upon study entry.
• Patients must be able to tolerate MRI/CT scans.
• Patients must be able to tolerate lumbar puncture and/or Ommaya taps.
• Participants must have recovered to grade 1 toxicity from prior therapy. NOTE: Patients who have initiated and received up to two cycles of treatment will NOT be excluded from study Arm A as long as all pretreatment assessments have been completed within 28 days of trial initiation.
• Arms B and D:
• Histologically documented B-cell non-Hodgkin's lymphoma involving the brain, spinal cord, and/or leptomeningeal space
• ° Patients in whom the type of lymphoma could not be determined or is unknown (e.g., not enough tissue for further analysis) are assumed to have a B cell lymphoma and are eligible

You may not qualify if…

• 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.
• Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject"s safety or put the study outcomes at undue risk.
• Patient has large pleural or ascetic fluid collection.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Prior severe allergic reaction to any of the study drugs that cannot be resolved with medication.
• Patient has undergone prior allogenic stem cell transplant (autologous stem cell transplant is NOT an exclusion).
• Arm Outpatient MTX Therapy in times of COVID-19:
• Patients eligible for this arm must not meet any of the following criteria:
• Patients with SCNSL requiring treatment for extra-CNS disease are excluded.
• Patients weighing <40kg
• Inadequate bone marrow and organ function shown by:
• Absolute neutrophil count (ANC) </= 0.5 x 10\^9/L
• Platelets </= 75 x 10\^9/L
• Hemoglobin (Hgb) </= 8 g/dL

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Dana Farber Cancer Institute (Data Collection and Specimen Analysis) — Boston, Massachusetts, United States
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic (Data Collection and Specimen Collection) — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.