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

Medac

Status and phase: Completed; Phase 3

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: asparaginase; Drug: recombinant asparaginase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784017

EudraCT number 2006-003180-31

MC-ASP.5/ALL

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 2 patient groups

asparaginase medac

Active Comparator group

Treatment:

Drug: asparaginase

recombinant asparaginase

Experimental group

Treatment:

Drug: recombinant asparaginase