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ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase

NCT00819351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2017-04-21

No results posted yet for this study

Summary

The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival

Conditions

Interventions

DRUG

PEG Asparaginase at six weeks interval

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)

DRUG

PEG Asparaginase at two weeks interval

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)

Sponsors & Collaborators

  • Nordic Society for Pediatric Hematology and Oncology

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kjeld Schmiegelow, M.D. · Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2016-03-02
Completion
2016-03-02

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT00819351 on ClinicalTrials.gov