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Antimetabolite
Glucarpidase for Central Nervous System Lymphoma
Phase < 1
Recruiting
Led By Lauren Schaff, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women must be at least 18 years of age on the day of consenting to the study
Patients who have already received two doses of treatment of CNS lymphoma are eligible for enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether Voraxaze, when given with the standard treatment for CNSL, is more effective than the standard treatment alone.
Who is the study for?
Adults with B-cell non-Hodgkin's lymphoma in the brain, spinal cord, or leptomeningeal space can join. They must be able to handle certain procedures and have recovered from previous treatments. Women of childbearing age need a negative pregnancy test and agree to birth control; men must also use contraception.Check my eligibility
What is being tested?
The trial is testing Voraxaze (Glucarpidase) combined with standard CNSL treatments methotrexate and rituximab. It aims to see if routine administration of Voraxaze improves outcomes for patients with central nervous system lymphoma.See study design
What are the potential side effects?
Possible side effects include allergic reactions to drug components, issues related to bone marrow suppression like low blood counts, potential liver or kidney problems due to organ function requirements, and general discomfort from lumbar punctures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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I have received two treatments for CNS lymphoma.
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I am able to care for myself but may not be able to do active work.
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My platelet count is healthy and I haven't had a platelet transfusion in the last 28 days.
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My B-cell non-Hodgkin's lymphoma affects my brain, spinal cord, or leptomeningeal space.
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My lymphoma affects my brain, spinal cord, or the space around my brain and spinal cord.
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I have taken MTX therapy without severe side effects.
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I am a woman who can have children and I have a negative pregnancy test.
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I am able to care for myself but cannot do normal activities or work.
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I do not need treatment for non-Hodgkin lymphoma.
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I can undergo spinal fluid tests without major issues.
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I can drink fluids by mouth.
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I have not been treated or my disease has clearly worsened as shown by recent scans.
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My B-cell non-Hodgkin's lymphoma affects my brain, spinal cord, or the space around my brain and spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients that have significant reduction of serum methotrexate levels
Trial Design
5Treatment groups
Experimental Treatment
Group I: Arm E-glucarpidase 1000u + MTX standard of careExperimental Treatment2 Interventions
Study treatment consists of glucarpidase 1000u, to be administered at least 24 hours after start of standard of care MTX. Patients will have a standard of care methotrexate level drawn within 6 hours of planned glucarpidase administration to confirm eligibility (must reflect MTX > 100 nmol/L)
Group II: Arm D -Rituximab + MTX + GlucarpidaseExperimental Treatment3 Interventions
Up to 12 patients will be included in Arm D of this study. Cycles will be 14 days long. All patients will receive MTX 3.5 g/m2 administered Day 1 of each cycle (+/- 7 days, a minimum of 14 days required between doses). Glucarpidase will be administered 24 hours (+/- 2 hr) after start of MTX infusion except in cycles 1-2 of Cohort B. Dose of glucarpidase will be 2000 units in Cohort A (first 4 patients) and 1000 units in Cohort B (remaining 8 patients). Patients in Arm D will receive 8 cycles of treatment. Cycles 1 and 2 will be administered in patient while Cycles 3-8 may be in the outpatient setting. Concurrent chemotherapy such as vincristine, procarbazine, and/or ibrutinib may be administered at the investigator's discretion and in accordance with standard of care. In Cohort B, all cycles will be administered with rituximab 500 mg/m2. Rituximab should be administered prior to glucarpidase (window -4 days).
Group III: Arm C - HD-MTX (Arm Outpatient MTX Therapy in times of COVID-19)Experimental Treatment2 Interventions
MTX ≤ 3.5 g/m2 will be administered on Day 1, along with pre- and post- hydration. Patients will return on Day 2 for continued hydration and glucarpidase 2000 units. Glucarpidase rapidly and sustainably reduces serum MTX levels >95% without crossing the blood brain barrier, effectively resulting in systemic MTX clearance. Patients will return for bloodwork on Day 3 to document MTX clearance. Arm Outpatient MTX Therapy in times of COVID-19 will only be a single-institution arm, only open at Memorial Sloan Kettering Cancer Center.
Group IV: Arm B - Rituximab + MTX + GlucarpidaseExperimental Treatment2 Interventions
Patients will receive up to 8 cycles of treatment consisting of rituximab Day 1 (+/- 7 days) and MTX Day 2 (+/- 7 days) as per standard of care. Voraxaze will be administered each cycle 24 hours (+/- 2 h) after start of MTX infusion. Dose of Voraxaze will be 2000 units during cycles 1-4, and 1000 units during cycles 5-8. Patients will be treated with rituximab 500 mg/m^2. (Cohort B) will receive MTX 8 g/m2. 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.
Group V: Arm A - Rituximab + MTX + GlucarpidaseExperimental Treatment4 Interventions
Patients will receive rituximab Day 1 (+/- 7 days) and MTX Day 2 (+/- 7 days) as per standard of care. Voraxaze will be administered each cycle 24 hours (+/- 2 h) after start of MTX infusion. Dose of Voraxaze will be 2000 units during cycles 1-4, and 1000 units during cycles 5-8. Patients will be treated with rituximab 500 mg/m^2. (Cohort A) will receive MTX 3 g/m2. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
leucovorin
2005
Completed Phase 3
~1200
Glucarpidase
2008
Completed Phase 3
~50
Methotrexate
2013
Completed Phase 4
~3800
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,834 Total Patients Enrolled
3 Trials studying Central Nervous System Lymphoma
97 Patients Enrolled for Central Nervous System Lymphoma
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,398 Total Patients Enrolled
Lauren Schaff, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old.You are allergic to any part of the study drug.You have serious and ongoing health problems.I have received two treatments for CNS lymphoma.I am scheduled for at least 6 more doses of methotrexate and do not need treatment for systemic non-Hodgkin lymphoma.I am 18 years old or older.I am able to care for myself but may not be able to do active work.My platelet count is healthy and I haven't had a platelet transfusion in the last 28 days.My B-cell non-Hodgkin's lymphoma affects my brain, spinal cord, or leptomeningeal space.My lymphoma affects my brain, spinal cord, or the space around my brain and spinal cord.I have CNS lymphoma and have had 2 or fewer treatment cycles, or my scans show it's getting worse.You had a severe allergic reaction to the study drugs in the past that cannot be treated with medicine.I am eligible for inpatient methotrexate treatment for CNS lymphoma.I have taken MTX therapy without severe side effects.I am a woman who can have children and I have a negative pregnancy test.I am not using any other cancer treatments.You are allergic to any part of the study drug.You have a serious ongoing medical condition.You have a medical condition that could be dangerous and make participating in the study risky.I weigh less than 40kg.I have lymphoma affecting my eyes and will have an eye exam after treatment.I've had cancer treatment recently and may still have side effects.I am currently receiving treatment for another cancer.I have not had treatments with radio- or toxin-immunoconjugates in the last 70 days.My lymphoma type is unknown, so it's treated as B cell lymphoma.I have CNS lymphoma and have had 2 or fewer treatment cycles, or my scans show it's getting worse.My tests show lymphoma cells in my spinal fluid or images showing disease in my spinal fluid.I've had 2 treatments for CNS lymphoma and will get at least 6 more methotrexate doses.I do not need treatment for non-Hodgkin lymphoma.I can care for myself but may not be able to do active work, especially if it's due to my illness affecting my nervous system.I can drink fluids by mouth.I am able to care for myself but cannot do normal activities or work.My bone marrow and organs are functioning well.I can undergo spinal fluid tests without major issues.I am not pregnant and willing to use contraception if of childbearing potential.I have had a stem cell transplant and/or CNS radiation but can still join.I have had radiation therapy to my brain within the last 28 days.I have a history of hepatitis B or C.I have a large buildup of fluid in my chest or abdomen.I have had a stem cell transplant from a donor.I am eligible for outpatient MTX therapy during COVID-19.I have a large fluid buildup in my chest or abdomen.My bone marrow and organs are not functioning properly.I do not need treatment for cancer outside my brain.I weigh less than 40kg.I do not have a severe illness or condition that could risk my safety in the study.I agree to use effective birth control during and for 3 months after treatment.I have recovered from side effects of my previous treatment.I have not been treated or my disease has clearly worsened as shown by recent scans.My B-cell non-Hodgkin's lymphoma affects my brain, spinal cord, or the space around my brain and spinal cord.My lymphoma type is assumed to be B cell due to insufficient tissue for analysis.You must be willing and able to come to all scheduled appointments, follow the treatment plan, and get all required tests done.You have enough healthy white blood cells called neutrophils.You should be able to undergo MRI or CT scan without any complications.I need treatment for cancer that has spread outside my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B - Rituximab + MTX + Glucarpidase
- Group 2: Arm E-glucarpidase 1000u + MTX standard of care
- Group 3: Arm D -Rituximab + MTX + Glucarpidase
- Group 4: Arm C - HD-MTX (Arm Outpatient MTX Therapy in times of COVID-19)
- Group 5: Arm A - Rituximab + MTX + Glucarpidase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Under what conditions is Voraxaze prescribed?
"Voraxaze is regularly prescribed for multiple sclerosis, but also proves effective in treating b-cell lymphomas, polyangium and other advanced directives."
Answered by AI
How many facilities are providing access to this scientific investigation?
"This study is currently enrolling patients at 10 different medical centres. These include Cleveland Clinic (for data and specimen collection) in Cleveland, Memorial Sloan Kettering Monmouth in Middletown, as well as Memoral Sloan Kettering Basking Ridge in Basking Ridge. Additionally there are seven other sites where recruitment is taking place."
Answered by AI
What is the scope of participant enrollment in this investigation?
"Indeed, the clinicaltrials.gov website reveals that this research is actively seeking participants. The initial posting for this trial was made on November 14th of 2018 and it has been updated as recently as November 1st 2022. 44 individuals from 10 different sites must be enrolled in order to complete the study's objectives."
Answered by AI
Are there still opportunities to join this research endeavor?
"Affirmative. Clinicaltrials.gov attests that this experiment, whose inception was on November 14th 2018, is actively enrolling participants. 44 people are required from 10 different sites for successful completion of the study."
Answered by AI
Have any other scientific experiments been conducted using Voraxaze?
"The National Institutes of Health Clinical Center in Rockville, Maryland first began researching Voraxaze back in 1993. Since then, 1765 studies have been successfully completed with 819 actively enrolling now across the United States; Cleveland, Ohio bears a majority of these trials currently underway."
Answered by AI
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