Trials / Active Not Recruiting
Active Not RecruitingNCT03684980
LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-11-14
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2018-09-26
- Last updated
- 2026-04-15
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03684980. Inclusion in this directory is not an endorsement.