drugset / Trial / NCT00199108

Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

NCT00199108

Phase 2/3 Completed 20 enrolled Goethe University
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2004-04
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intrathecal
Background Dexamethasone Small molecule