NCT00983138

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

1.6 years

First QC Date

September 22, 2009

Last Update Submit

February 28, 2011

Conditions

Acute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

  • number of patients with hypersensitivity reactions to rASNase

    within 2 months

Secondary Outcomes (1)

  • pharmacodynamic of rASNase

    within 33 days

Study Arms (1)

recombinant asparaginase

EXPERIMENTAL
Drug: recombinant asparaginase

Interventions

recombinant asparaginaseDRUG

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

recombinant asparaginase

Eligibility Criteria

AgeUp to 364 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospital Charité Virchow

Berlin, 13353, Germany

Location

University Hospital Bonn

Bonn, 53113, Germany

Location

University Hospital Erlangen

Erlangen, 91054, Germany

Location

University Hospital Essen

Essen, 45147, Germany

Location

University Hospital Johann Wolfgang Goethe

Frankfurt, 60590, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Medical University Hannover

Hanover, 30625, Germany

Location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

University Hospital Münster

Münster, 48149, Germany

Location

Olga Hospital

Stuttgart, 70174, Germany

Location

VU University Medical Centre

Amsterdam, 1081, Netherlands

Location

Academic Medical Centre AMC/EK2

Amsterdam, 1105, Netherlands

Location

University of Groningen

Groningen, 9713, Netherlands

Location

University Children's Hospital Nijmegen

Nijmegen, 6500, Netherlands

Location

Sophia Children's Hospital

Rotterdam, 3015, Netherlands

Location

University Medical Centre Utrecht

Utrecht, 3584, Netherlands

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

asparaginase erwinia chrysanthemi recombinant

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rob Pieters, MD

    Erasmus MC-Sophia Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

NL(6)DE(11)