Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt
Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented
 isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy
 with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase
 each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3
 weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary
 objective is the response rate after one application of DepoCyte. Further objectives are the
 compilation of data regarding safety and toxicity
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