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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2, 2016

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

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)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Event Free Survival
    • Time Frame: 6 years

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • Nordic Society for Pediatric Hematology and Oncology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kjeld Schmiegelow, Professor – Rigshospitalet, Denmark
  • Overall Official(s)
    • Kjeld Schmiegelow, M.D., Study Chair, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

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