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NCT00819351 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-04-21

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
45 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: PEG Asparaginase at six weeks interval
    label
    PEG-asparaginase 6 weeks intervals
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: PEG Asparaginase at two weeks interval
    label
    PEG-Asparaginase 2 weeks intervals
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. PEG-asparaginase 6 weeks intervals
    description
    PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
    name
    PEG Asparaginase at six weeks interval
    other Names
    1. Oncaspar (PEG-Asparaginase)
    type
    DRUG
  2. arm Group Labels
    1. PEG-Asparaginase 2 weeks intervals
    description
    PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
    name
    PEG Asparaginase at two weeks interval
    other Names
    1. Oncaspar (PEG-Asparaginase)
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
650
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Event Free Survival
    time Frame
    6 years
secondary Outcomes
  1. measure
    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
Full study description
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
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
Source references
references
  1. citation
    Albertsen BK, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jonsson OG, Frandsen TL, Wolthers BO, Heyman M, Schmiegelow K. Intermittent Versus Continuous PEG-Asparaginase to Reduce Asparaginase-Associated Toxicities: A NOPHO ALL2008 Randomized Study. J Clin Oncol. 2019 Jul 1;37(19):1638-1646. doi: 10.1200/JCO.18.01877. Epub 2019 Apr 12.
    pmid
    30978155
    type
    DERIVED
  2. citation
    Tram Henriksen L, Gottschalk Hojfeldt S, Schmiegelow K, Frandsen TL, Skov Wehner P, Schroder H, Klug Albertsen B; Nordic Society of Pediatric Hematology and Oncology, NOPHO Group. Prolonged first-line PEG-asparaginase treatment in pediatric acute lymphoblastic leukemia in the NOPHO ALL2008 protocol-Pharmacokinetics and antibody formation. Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26686. Epub 2017 Jun 29.
    pmid
    28660740
    type
    DERIVED
  3. citation
    Nielsen SN, Grell K, Nersting J, Abrahamsson J, Lund B, Kanerva J, Jonsson OG, Vaitkeviciene G, Pruunsild K, Hjalgrim LL, Schmiegelow K. DNA-thioguanine nucleotide concentration and relapse-free survival during maintenance therapy of childhood acute lymphoblastic leukaemia (NOPHO ALL2008): a prospective substudy of a phase 3 trial. Lancet Oncol. 2017 Apr;18(4):515-524. doi: 10.1016/S1470-2045(17)30154-7. Epub 2017 Mar 1.
    pmid
    28258828
    type
    DERIVED
  4. citation
    Wolthers BO, Frandsen TL, Abrahamsson J, Albertsen BK, Helt LR, Heyman M, Jonsson OG, Korgvee LT, Lund B, Raja RA, Rasmussen KK, Taskinen M, Tulstrup M, Vaitkeviciene GE, Yadav R, Gupta R, Schmiegelow K. Asparaginase-associated pancreatitis: a study on phenotype and genotype in the NOPHO ALL2008 protocol. Leukemia. 2017 Feb;31(2):325-332. doi: 10.1038/leu.2016.203. Epub 2016 Jul 25.
    pmid
    27451978
    type
    DERIVED
  5. citation
    Henriksen LT, Harila-Saari A, Ruud E, Abrahamsson J, Pruunsild K, Vaitkeviciene G, Jonsson OG, Schmiegelow K, Heyman M, Schroder H, Albertsen BK; Nordic Society of Paediatric Haematology and Oncology (NOPHO) group. PEG-asparaginase allergy in children with acute lymphoblastic leukemia in the NOPHO ALL2008 protocol. Pediatr Blood Cancer. 2015 Mar;62(3):427-33. doi: 10.1002/pbc.25319. Epub 2014 Nov 21.
    pmid
    25418987
    type
    DERIVED
  6. citation
    Raja RA, Schmiegelow K, Albertsen BK, Prunsild K, Zeller B, Vaitkeviciene G, Abrahamsson J, Heyman M, Taskinen M, Harila-Saari A, Kanerva J, Frandsen TL; Nordic Society of Paediatric Haematology and Oncology (NOPHO) group. Asparaginase-associated pancreatitis in children with acute lymphoblastic leukaemia in the NOPHO ALL2008 protocol. Br J Haematol. 2014 Apr;165(1):126-33. doi: 10.1111/bjh.12733. Epub 2014 Jan 15.
    pmid
    24428625
    type
    DERIVED
see Also Links
  1. label
    Home Page of NOPHO-most areas are closed
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        e who received chemotherapy only (n = 88), after adjusting for waiting time to HSCT (5.7 months).</li></ul></div></li><li>On the NOPHO <a href="/clinicaltrials/NCT00819351">ALL2008 (NCT00819351)</a> protocol, patients were allocated to HSCT in first CR if they had MRD levels of 5% or greater at the end of induction or MRD levels
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      2. context exact
        erapy only (n = 88), after adjusting for waiting time to HSCT (5.7 months).</li></ul></div></li><li>On the NOPHO <a href="/clinicaltrials/NCT00819351">ALL2008 (NCT00819351)</a> protocol, patients were allocated to HSCT in first CR if they had MRD levels of 5% or greater at the end of induction or MRD levels of 0.1% or greater at
        end
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        exact text
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        start
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      source retrieved at
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      source string sha256
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      source title
      Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice