ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00819351

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 III

MedlinePlus related topics: Leukemia, Childhood

Drug Information available for: L-Asparaginase Pegaspargase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-Asparaginase for Asparagine Depletion

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
2: Experimental 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 six weeks interval PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
1: Active Comparator PEG-asparaginase (1.000 IU/m2/dose) given at two 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)

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 17 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

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
Copenhagen, Denmark, 2100
Finland
Helsinki University Hospital
Helsinki, Finland
Iceland
University Hospital Reykjavik, Iceland
Reykjavik, Iceland
Norway
Trondheim University Hospital
Trondheim, Norway
Sweden
NOPHO nordic organisation for pediatric onology
Stockholm, Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, Sweden

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Chair:

Kjeld Schmiegelow, M.D.

Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

More Information

Home Page of NOPHO-most areas are closed This link exits the ClinicalTrials.gov site

Responsible Party:	University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen ( Kjeld Schmiegelow, Professor )
Study ID Numbers:	NOPHO ALL2008 PEG Asparaginase
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819351
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

acute lymphoblastic leukemia
child
PEG-Asparaginase

EFS
efficacy
childhood acute lymphoblastic leukemia

Study placed in the following topic categories:

Asparaginase
Pegaspargase
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009