A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
3 weeks
No
Nicola Gökbuget, MD
Principal Investigator
Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt
Germany: Federal Institute for Drugs and Medical Devices
MC-PEGASP.1/adults
NCT01251809
January 2011
May 2013
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