Trials / Completed
CompletedNCT00784017
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 199 (actual)
- Sponsor
- medac GmbH · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
Summary
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | asparaginase | 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 |
| DRUG | recombinant asparaginase | 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2008-11-03
- Last updated
- 2013-02-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00784017. Inclusion in this directory is not an endorsement.