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Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

Primary Purpose

Acute Lymphoid Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
recombinant asparaginase
Sponsored by
medac GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoid Leukemia

Eligibility Criteria

undefined - 364 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
  • Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping.
  • Age < 1 year at diagnosis.
  • Written informed consent of the parents or other legally authorised guardian of the patient.
  • Treatment according to protocol INTERFANT 06

Exclusion Criteria:

  • Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
  • The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
  • Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
  • Known allergy to any ASNase preparation.
  • Pre-existing known coagulopathy (e.g. haemophilia).
  • Pre-existing pancreatitis.
  • Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).

Sites / Locations

  • Hospital Charité Virchow
  • University Hospital Bonn
  • University Hospital Erlangen
  • University Hospital Essen
  • University Hospital Johann Wolfgang Goethe
  • University Hospital Freiburg
  • University Hospital Hamburg-Eppendorf
  • Medical University Hannover
  • University Hospital Schleswig-Holstein, Campus Kiel
  • University Hospital Münster
  • Olga Hospital
  • VU University Medical Centre
  • Academic Medical Centre AMC/EK2
  • University of Groningen
  • University Children's Hospital Nijmegen
  • Sophia Children's Hospital
  • University Medical Centre Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

recombinant asparaginase

Arm Description

Outcomes

Primary Outcome Measures

number of patients with hypersensitivity reactions to rASNase

Secondary Outcome Measures

pharmacodynamic of rASNase

Full Information

First Posted
September 22, 2009
Last Updated
February 28, 2011
Sponsor
medac GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00983138
Brief Title
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
Official Title
Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
medac GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
recombinant asparaginase
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
recombinant asparaginase
Intervention Description
10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy
Primary Outcome Measure Information:
Title
number of patients with hypersensitivity reactions to rASNase
Time Frame
within 2 months
Secondary Outcome Measure Information:
Title
pharmacodynamic of rASNase
Time Frame
within 33 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
364 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria. Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping. Age < 1 year at diagnosis. Written informed consent of the parents or other legally authorised guardian of the patient. Treatment according to protocol INTERFANT 06 Exclusion Criteria: Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL. The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible. Known allergy to any ASNase preparation. Pre-existing known coagulopathy (e.g. haemophilia). Pre-existing pancreatitis. Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Pieters, MD
Organizational Affiliation
Erasmus MC-Sophia Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Charité Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
ZIP/Postal Code
53113
Country
Germany
Facility Name
University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
University Hospital Johann Wolfgang Goethe
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Hospital Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University Hospital Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medical University Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Hospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Olga Hospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
VU University Medical Centre
City
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Facility Name
Academic Medical Centre AMC/EK2
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
University of Groningen
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
University Children's Hospital Nijmegen
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands

12. IPD Sharing Statement

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Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

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