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

February 26, 2013 updated by: medac GmbH
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, NL-3015
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously untreated T-lineage or precursor B-lineage ALL
  • Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
  • Written informed consent
  • Treatment according to DCOG ALL 10 protocol

Exclusion Criteria:

  • Mature B-lineage ALL
  • Patients with secondary ALL
  • Known allergy to any ASNase preparation
  • General health status according to Karnofsky / Lansky score < 40%
  • Pre-existing known coagulopathy (e.g. haemophilia)
  • Pre-existing pancreatitis
  • Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
  • Other current malignancies
  • Pregnancy (planned or existent), breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: asparaginase medac
Drug: asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Experimental: recombinant asparaginase
Drug: recombinant asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
Time Frame: March 2012
March 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Time Frame: March 2012
March 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 31, 2008

First Submitted That Met QC Criteria

October 31, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-ASP.5/ALL
  • EudraCT number 2006-003180-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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