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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Nordic Society for Pediatric Hematology and Oncology
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00819351
First received: January 8, 2009
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: PEG Asparaginase at six weeks interval
Drug: PEG Asparaginase at two weeks interval
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Event Free Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33).

All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

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)
Other Name: Oncaspar (PEG-Asparaginase)
Active Comparator: 1

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33).

All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

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)
Other Name: Oncaspar (PEG-Asparaginase)

Detailed Description:

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

To test 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 EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed

  Eligibility

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Childhood ALL
  • All mandatory biological data are available6
  • Written informed consent has been obtained

Exclusion Criteria:

  • Bilineage ALL
  • Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
  • ALL predisposition syndromes
  • Previous cancer
  • Off protocol administration of additional chemotherapy during induction therapy
  • Sexually active females not using contraception
  • No allergic reactions to PEG Asparaginase
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819351

Contacts
Contact: Kjeld Schmiegelow, M.D. +45 35451357 kschmiegelow@rh.regionh.dk
Contact: Thomas Frandsen, M.D. +45 35458364 thomas.leth.frandsen@rh.regionh.dk

Locations
Denmark
Department of Pediatrics, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Kjeld Schmiegelow, M.D.    +4535451357    kschmiegelow@rh.regionh.dk   
Contact: Thomas Frandsen, M.D.    +4535458364    thomas.leth.frandsen@rh.regionh.dk   
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Kim Vettenranta, M.D.    + 35 850-3676528    kim.vettenranta@hus.fi   
Iceland
University Hospital Reykjavik, Iceland Recruiting
Reykjavik, Iceland
Contact: Olafur Jonsson, M.D.    +354 5431000    olafurgi@landspitali.is   
Norway
Trondheim University Hospital Recruiting
Trondheim, Norway
Contact: Ann Åsberg, M.D.    + 47 92626432    ann.asberg@ntnu.no   
Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital Recruiting
Gothenburg, Sweden
Contact: Jonas Abrahamson, M.D.    46-707-69-5159    jonas.abrahamsson@vgregion.se   
NOPHO nordic organisation for pediatric onology Recruiting
Stockholm, Sweden
Contact: Mats Heyman, M.D.    +46 706287698    mats.heyman@ki.se   
Contact: Thomas Frandsen, M.D.    +45 3545 8364    t-frandsen@dadlnet.dk   
Principal Investigator: Stefan Söderhäll, M.D.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Nordic Society for Pediatric Hematology and Oncology
Investigators
Study Chair: Kjeld Schmiegelow, M.D. Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
  More Information

Additional Information:
No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00819351     History of Changes
Other Study ID Numbers: NOPHO ALL2008 PEG Asparaginase
Study First Received: January 8, 2009
Last Updated: May 22, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
acute lymphoblastic leukemia
child
PEG-Asparaginase
EFS
efficacy
childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014