NCT01251809

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukaemia

Interventions

Type	Name	Description
DRUG	Oncaspar	2000 U/m2 BSA, single infusion
DRUG	PEG-rASNase	500, 1000 or 1500 U/m2 BSA single infusion

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-10-01
• Completion: 2013-05-01
• First posted: 2010-12-02
• Last updated: 2013-05-20

Locations

30 sites across 1 country: Germany