A Phase-2 Clinical Study to Determine the Efficacy and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of CNS Relapse in Adult Patients With Acute Lymphoblastic Leukemia or Very Aggressive Lymphoma
Inclusion Criteria:
- proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma
(Burkitt/Burkitt-like) and CNS relapse
- CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or
characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan
indicating the presence of meningeal involvement
- in combined relapse in CNS and other locations: systemic therapy with CNS active
drugs can be postponed for at least 2 weeks
- Karnofsky Performance Score is > or = 60%
- 18 years of age or older
- free of uncontrolled infection
- recovered from any grade III / IV toxicities attributable to prior treatment with the
exception of hematotoxicity
- patient not pregnant or breast feeding and effective methods to prevent pregnancy
- free from severe heart, lung, liver or kidney dysfunction
- written informed consent
Exclusion Criteria:
- failed to respond (as defined by no clearance of the CSF) to > 1 dose of prior i.th.
MTX or ARAC or triple therapy
- history of neurotoxicity (grade III - IV) attributed to i.th. or systemic HD therapy
with MTX or ARAC
- prior CNS relapse < 1 month before