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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt | ||||
| Official Title † | 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 | ||||
| Brief 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 |
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| Detailed Description | |||||
| Study Phase | Phase II, Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | response rate after one application of DepoCyte | ||||
| Secondary Outcome Measure † | response rate at later time-points, toxicity (WHO), death in induction and CR, time to neurological progression, frequency of improvement in pre-existing meningeal-disease related neurological symptoms, Karnofsky Performance Status, Survival | ||||
| Condition † | Adult Acute Lymphocytic Leukemia | ||||
| Intervention † | Drug: Depocyt Drug: Dexamethasone |
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| MEDLINE PMIDs | |||||
| Links | European Leukemia Trial Registry ![]() German Leukemia Trial Registry  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 20 | ||||
| Start Date † | April 2004 | ||||
| Completion Date | June 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00199108 | ||||
| Organization ID | GMALL06 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Johann Wolfgang Goethe University Hospitals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | May 29, 2008 | ||||