Trials / Completed
CompletedNCT00199108
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Goethe University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Depocyt | |
| DRUG | Dexamethasone |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2005-09-20
- Last updated
- 2022-08-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00199108. Inclusion in this directory is not an endorsement.