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

• Sponsor: medac GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00784017
• Collaborator: (none)
• Enrollment: 199
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: asparaginase; Drug: recombinant asparaginase	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment [March 2012]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Erasmus MC	Rotterdam		Netherlands	NL-3015

Sponsors and Collaborators

• medac GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: medac GmbH
• ClinicalTrials.gov Identifier: NCT00784017
• Other Study ID Numbers: MC-ASP.5/ALL; EudraCT number 2006-003180-31
• First Posted: Nov 2, 2008
• Last Update Posted: Feb 27, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by medac GmbH: Children with previously untreated acute lymphoblastic leukemia
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Asparaginase

Study Results

No Results Posted as of Feb 27, 2013