drugset / Trial / NCT00723346
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective : * To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (\< 2µmol/l) Secondary objective : * Pharmacokinetic / Pharmacodynamic parameters * toxicity * Study duration : 2 years * Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase * Associated treatments : COPRALL chemotherapy * Randomization : centralised randomisation on scratching list
Timeline
- Start
- 2006-01
- Primary completion
- 2008-08
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GRASPA | Protein / enzyme biologic | 50 iu/kg | — |
| Subject | GRASPA | Protein / enzyme biologic | 100 iu/kg | — |
| Subject | GRASPA | Protein / enzyme biologic | 150 iu/kg | — |
| Comparator | native L asparaginase | Unknown | 10000 iu | — |