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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
asparaginase
recombinant asparaginase
Sponsored by
medac GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Children with previously untreated acute lymphoblastic leukemia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

asparaginase medac

recombinant asparaginase

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment

Full Information

First Posted
October 31, 2008
Last Updated
February 26, 2013
Sponsor
medac GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00784017
Brief Title
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Official Title
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
medac GmbH

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Children with previously untreated acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
asparaginase medac
Arm Type
Active Comparator
Arm Title
recombinant asparaginase
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Description
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Intervention Type
Drug
Intervention Name(s)
recombinant asparaginase
Intervention Description
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Primary Outcome Measure Information:
Title
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
Time Frame
March 2012
Secondary Outcome Measure Information:
Title
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Time Frame
March 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
NL-3015
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29727043
Citation
van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4.
Results Reference
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Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

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