drugset / Trial / NCT01523782
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).
Timeline
- Start
- 2009-04
- Primary completion
- 2011-01
- Completion
- 2012-10
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 | — |