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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784017
• Other study ID #: MC-ASP.5/ALL
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2008
• Last updated: February 26, 2013
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
• recombinant asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		March 2012	No
Secondary	To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment		March 2012	Yes