Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Information source: medac GmbH
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia
Intervention: asparaginase (Drug); recombinant asparaginase (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: medac GmbH Overall contact:
Ann-Kristin Möller, PhD, Phone: +49 41038006, Ext: 485, Email: a.moeller@medac.de
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
Clinical Details
Official title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Ann-Kristin Möller, PhD, Phone: +49 41038006, Ext: 485, Email: a.moeller@medac.de
Erasmus MC, Rotterdam NL-3015, Netherlands; Recruiting
Additional Information
Starting date: October 2008
Last updated: February 3, 2010
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