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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014