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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00983138
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : March 1, 2011
Information provided by:
medac GmbH

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

Condition or disease Intervention/treatment Phase
Acute Lymphoid Leukemia Drug: recombinant asparaginase Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
Study Start Date : July 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: recombinant asparaginase Drug: recombinant asparaginase
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 Measures :
  1. number of patients with hypersensitivity reactions to rASNase [ Time Frame: within 2 months ]

Secondary Outcome Measures :
  1. pharmacodynamic of rASNase [ Time Frame: within 33 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 364 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00983138

Hospital Charité Virchow
Berlin, Germany, 13353
University Hospital Bonn
Bonn, Germany, 53113
University Hospital Erlangen
Erlangen, Germany, 91054
University Hospital Essen
Essen, Germany, 45147
University Hospital Johann Wolfgang Goethe
Frankfurt, Germany, 60590
University Hospital Freiburg
Freiburg, Germany, 79106
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
Medical University Hannover
Hannover, Germany, 30625
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
University Hospital Münster
Münster, Germany, 48149
Olga Hospital
Stuttgart, Germany, 70174
VU University Medical Centre
Amsterdam, Netherlands, 1081
Academic Medical Centre AMC/EK2
Amsterdam, Netherlands, 1105
University of Groningen
Groningen, Netherlands, 9713
University Children`s Hospital Nijmegen
Nijmegen, Netherlands, 6500
Sophia Children's Hospital
Rotterdam, Netherlands, 3015
University Medical Centre Utrecht
Utrecht, Netherlands, 3584
Sponsors and Collaborators
medac GmbH
Principal Investigator: Rob Pieters, MD Erasmus MC-Sophia Children's Hospital

Responsible Party: Cécile Guimbal-Schmolck, PhD, medac GmbH Identifier: NCT00983138     History of Changes
Other Study ID Numbers: MC-ASP.6/INF
EudraCT No: 2008-006300-27
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents