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

February 28, 2011 updated by: medac GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 11 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with hypersensitivity reactions to rASNase
Time Frame: within 2 months
within 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pharmacodynamic of rASNase
Time Frame: within 33 days
within 33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Investigators

  • Principal Investigator: Rob Pieters, MD, Erasmus MC-Sophia Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (ESTIMATE)

September 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-ASP.6/INF
  • EudraCT No: 2008-006300-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Lymphoid Leukemia

Clinical Trials on recombinant asparaginase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe