drugset / Trial / NCT01251809

Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

NCT01251809

Phase 1/2 Terminated 56 enrolled medac GmbH
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

EvaluationDrugModalityDoseRoute
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