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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

Page last updated: October 04, 2010

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