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Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

NCT00784017 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2013-02-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784017 on ClinicalTrials.gov