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

Acute Lymphoid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983138
• Other study ID #: MC-ASP.6/INF
• Secondary ID: EudraCT No: 2008
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: February 28, 2011
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 364 Days

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	Hospital Charité Virchow	Berlin
Germany	University Hospital Bonn	Bonn
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Essen	Essen
Germany	University Hospital Johann Wolfgang Goethe	Frankfurt
Germany	University Hospital Freiburg	Freiburg
Germany	University Hospital Hamburg-Eppendorf	Hamburg
Germany	Medical University Hannover	Hannover
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel
Germany	University Hospital Münster	Münster
Germany	Olga Hospital	Stuttgart
Netherlands	Academic Medical Centre AMC/EK2	Amsterdam
Netherlands	VU University Medical Centre	Amsterdam
Netherlands	University of Groningen	Groningen
Netherlands	University Children`s Hospital Nijmegen	Nijmegen
Netherlands	Sophia Children's Hospital	Rotterdam
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with hypersensitivity reactions to rASNase		within 2 months	Yes
Secondary	pharmacodynamic of rASNase		within 33 days	No