Voraxaze for Central Nervous System Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Central Nervous System LymphomaVoraxaze - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether Voraxaze, when given with the standard treatment for CNSL, is more effective than the standard treatment alone.

Eligible Conditions
  • Central Nervous System Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
number of patients that have significant reduction of serum methotrexate levels

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Arm A - Rituximab + MTX
1 of 8
Arm B - Rituximab + MTX
1 of 8
Arm C - HD-MTX
1 of 8
Arm D - MTX + Voraxaze
1 of 8
Arm B - Rituximab + MTX + Glucarpidase
1 of 8
Arm A - Rituximab + MTX + Glucarpidase
1 of 8
Arm C - HD-MTX (Arm Outpatient MTX Therapy in times of COVID-19)
1 of 8
Arm D -Rituximab + MTX + Glucarpidase
1 of 8

Experimental Treatment

44 Total Participants · 8 Treatment Groups

Primary Treatment: Voraxaze · No Placebo Group · Phase < 1

Arm A - Rituximab + MTXExperimental Group · 5 Interventions: Glucarpidase, Voraxaze, leucovorin, Methotrexate, Rituximab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Arm B - Rituximab + MTXExperimental Group · 3 Interventions: Glucarpidase, Voraxaze, Rituximab · Intervention Types: Drug, Drug, Drug
Arm C - HD-MTXExperimental Group · 2 Interventions: Glucarpidase, Methotrexate · Intervention Types: Drug, Drug
Arm D - MTX + VoraxazeExperimental Group · 2 Interventions: Glucarpidase, Methotrexate · Intervention Types: Drug, Drug
Arm B - Rituximab + MTX + GlucarpidaseExperimental Group · 2 Interventions: Glucarpidase, Rituximab · Intervention Types: Drug, Drug
Arm A - Rituximab + MTX + GlucarpidaseExperimental Group · 4 Interventions: Glucarpidase, leucovorin, Methotrexate, Rituximab · Intervention Types: Drug, Drug, Drug, Drug
Arm C - HD-MTX (Arm Outpatient MTX Therapy in times of COVID-19)Experimental Group · 2 Interventions: Glucarpidase, Methotrexate · Intervention Types: Drug, Drug
Arm D -Rituximab + MTX + GlucarpidaseExperimental Group · 3 Interventions: Glucarpidase, Methotrexate, Rituximab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucarpidase
FDA approved
Leucovorin
FDA approved
Methotrexate
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,364 Total Patients Enrolled
3 Trials studying Central Nervous System Lymphoma
97 Patients Enrolled for Central Nervous System Lymphoma
University of Alabama at BirminghamOTHER
1,434 Previous Clinical Trials
2,229,168 Total Patients Enrolled
Lauren Schaff, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
57 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who have already received two doses of treatment of CNS lymphoma are eligible for enrollment.
The tumor must be of B-cell origin and involve the brain, spinal cord, or leptomeningeal space.
Patients must have a KPS ≥ 50.
You must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
The ANC is ≥ 1.0 x 10^9/L.\n