Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children (CILI)

• number of cerebrospinal fluid (CSF) responses [ Time Frame: from two weeks after date of patient registration until the date of second consecutive cerebrospinal fluid exam that is negative for malignant cells, up to 12 weeks ] [ Designated as safety issue: No ]
  
• number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02 [ Time Frame: assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks ] [ Designated as safety issue: Yes ]
  

• time to reaching CSF response [ Time Frame: date of patient registration to date of CSF response, up to 12 weeks ] [ Designated as safety issue: No ]
  date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF
  
  
• duration of CSF response [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  duration of response is the length of time in days from the date of the CSF response to the date of the first positive cytomorphologic CSF exam
  
  
• worst grade non neurologic Adverse event during induction, according to CTCAE 4.02 [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  
• worst grade toxicity after induction therapy according to CTCAE 4.02 [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  Measured from date of CSF response
  
  
• overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  
• time from patient registration to progression of disease in non CNS site [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  
• concentration of study drug present in CSF at each induction therapy [ Time Frame: prior to each induction therapy at 15 day intervals for up to 6 cycles ] [ Designated as safety issue: No ]
  
• correlation of activity and toxicity with residual study drug level in CSF during induction [ Time Frame: measured at 15 day intervals for up to 6 cycles ] [ Designated as safety issue: No ]
  

Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of ALL. This formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. This allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.