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

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ClinicalTrials.gov Identifier: NCT00819351
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Nordic Society for Pediatric Hematology and Oncology
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark

Brief 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

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

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : March 2, 2016


Arm Intervention/treatment
Experimental: PEG-asparaginase 6 weeks intervals

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: PEG-Asparaginase 2 weeks intervals

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)



Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819351


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
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, Sweden
NOPHO nordic organisation for pediatric onology
Stockholm, Sweden
Sponsors and Collaborators
Rigshospitalet, Denmark
Nordic Society for Pediatric Hematology and Oncology
Investigators
Study Chair: Kjeld Schmiegelow, M.D. Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Additional Information:
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
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Asparaginase
6-Mercaptopurine
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors