drugset / Trial / NCT01251809
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-10
- Completion
- 2013-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-rASNase | Unknown | 500 iu | — |
| Subject | PEG-rASNase | Unknown | 1000 iu | — |
| Subject | PEG-rASNase | Unknown | 1500 iu | — |
| Comparator | Pegaspargase | Protein / enzyme biologic | 2000 iu | — |