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

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ClinicalTrials.gov Identifier: NCT00784017
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: asparaginase Drug: recombinant asparaginase Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Study Start Date : October 2008
Primary Completion Date : October 2012
Study Completion Date : October 2012


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment [ Time Frame: March 2012 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784017


Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, NL-3015
Sponsors and Collaborators
medac GmbH
More Information

Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT00784017     History of Changes
Other Study ID Numbers: MC-ASP.5/ALL
EudraCT number 2006-003180-31
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

Keywords provided by medac GmbH:
Children with previously untreated acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents