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Completed

NCT Number: NCT00983138

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

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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Key information

Conditions

Acute Lymphoid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 364 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Charité Virchow, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

recombinant asparaginase

Drug

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 outcomes

  1. number of patients with hypersensitivity reactions to rASNase

    Time frame: within 2 months

Secondary outcomes

  1. pharmacodynamic of rASNase

    Time frame: within 33 days

Sponsors and collaborators

Lead sponsor

medac GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 23, 2009
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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