NCT00819351

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2016

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

7.2 years

First QC Date

January 8, 2009

Last Update Submit

April 20, 2017

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemiachildPEG-AsparaginaseEFSefficacychildhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

  • Event Free Survival

    6 years

Secondary Outcomes (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.

    6 years

Study Arms (2)

PEG-asparaginase 6 weeks intervals

EXPERIMENTAL

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 2 weeks intervals

ACTIVE COMPARATOR

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

Interventions

PEG Asparaginase at six weeks intervalDRUG

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)

Also known as: Oncaspar (PEG-Asparaginase)
PEG-asparaginase 6 weeks intervals
PEG Asparaginase at two weeks intervalDRUG

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)

Also known as: Oncaspar (PEG-Asparaginase)
PEG-Asparaginase 2 weeks intervals

Eligibility Criteria

Age1 Year - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Pediatrics, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

University Hospital Reykjavik, Iceland

Reykjavik, Iceland

Location

Trondheim University Hospital

Trondheim, Norway

Location

Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Gothenburg, Sweden

Location

NOPHO nordic organisation for pediatric onology

Stockholm, Sweden

Location

Related Publications (6)

  • 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: 30978155DERIVED

  • 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: 28660740DERIVED

  • 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: 28258828DERIVED

  • 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: 27451978DERIVED

  • 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: 25418987DERIVED

  • 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: 24428625DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kjeld Schmiegelow, M.D.

    Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

January 1, 2009

Primary Completion

March 2, 2016

Study Completion

March 2, 2016

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

IC(1)DK(1)SE(2)FI(1)NO(1)