Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.
It is a clinical study multicenter, prospective, open label trial, uncontrolled and
 nonrandomized
Inclusion Criteria:

 -  Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma
 (Burkitt/Burkitt-like) and CNS relapse.

 CNS involvement must be demonstrated by:

 -  A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3
 cells), obtained within 10 days prior to inclusion OR

 -  Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan
 indicating the presence of meningeal involvement. Patients with combined relapse in
 CNS and other locations may be included in case that systemic therapy with CNS active
 drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks.

 -  Karnofsky >60%

 -  Age >18 years old

 -  Recovery from grade III/IV toxicities attributable to prior treatment with the
 exception of hematotoxicity.

 -  No severe heart, lung, liver or kidney dysfunction.

 -  The patient or guardian must be competent to provide informed consent and must provide
 written informed consent prior to the initiation of study procedures

 Exclusion Criteria:

 -  Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX
 or cytarabine or triple (MTX, ARAC, dexamethasone) therapy

 -  History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal
 therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine
 induced peripheral neuropathy is accepted)

 -  Prior CNS relapse < 1 month before

 -  uncontrolled infection

 -  The patient must not be pregnant or breast feeding. If the patient is a female of
 child-bearing potential she must have a negative (urine or serum) pregnancy test and
 be using effective methods to prevent pregnancy