A Phase I/II Study to Investigate the Use of VORAXAZE™ as Intended Intervention in Patients With CNSL
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
This phase I-II trial is intented to demonstrate tolerability (i.e. absence of severe
non-hematological toxicity) and efficacy of intended intervention with repeated doses of
Voraxaze, in addition to leucovorin (LV), in patients with renal impairment or renal failure
during previous HD-MTX therapy.
Patients will receive up to 6 cycles of HD-MTX treatment with 14 days between cycles (a
maximum delay of 28 days is permitted in order to allow time for a patient to recover from
the previous cycle).