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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
medac GmbH
ClinicalTrials.gov Identifier:
NCT00784017
First received: October 31, 2008
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
 Drug: asparaginase
Drug: recombinant asparaginase
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by medac GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment [ Time Frame: March 2012 ] [ Designated as safety issue: Yes ]

Enrollment: 199
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784017

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

No publications provided

Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT00784017     History of Changes
Other Study ID Numbers: MC-ASP.5/ALL, EudraCT number 2006-003180-31
Study First Received: October 31, 2008
Last Updated: February 26, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on June 17, 2013