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

NCT00983138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-03-01

No results posted yet for this study

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

Conditions

  • Acute Lymphoid Leukemia

Interventions

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

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Rob Pieters, MD · Erasmus MC-Sophia Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
364 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983138 on ClinicalTrials.gov