Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003784

Trial Description

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Title

Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003784
  •   2012/05/02
  •   2009/09/22
  •   no
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Secondary IDs

  •   2008-006300-27 
  •   NCT00983138  (ClinicalTrials.gov)
  •   MC-ASP.6/INF  (medac GmbH)
  •   EudraCT No: 2008-006300-27 
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Health Condition or Problem studied

  •   Acute Lymphoid Leukemia
  •   C91.0 -  Acute lymphoblastic leukaemia
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Interventions/Observational Groups

  •   Drug: recombinant asparaginase
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- number of patients with hypersensitivity reactions to rASNase; time frame: within 2 months

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Secondary Outcome

- pharmacodynamic of rASNase; time frame: within 33 days

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Countries of Recruitment

  •   Germany
  •   Netherlands
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Locations of Recruitment

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Recruitment

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  •   2009/07/31
  •   12
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   364   Days
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Additional 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

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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).

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Addresses

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    • medac GmbH
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    • Erasmus MC-Sophia Children's Hospital
    • Rob Pieters, MD 
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    • Erasmus MC-Sophia Children's Hospital
    • Rob Pieters, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2011/02/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.