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Acute Lymphoblastic LeukemiaPhase 3NCT00819351

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

A Phase 3 study testing PEG Asparaginase at six weeks interval and PEG Asparaginase at two weeks interval in people with Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 1 year to 45 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
PEG Asparaginase at six weeks interval and PEG Asparaginase at two weeks interval
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
6 sitesin 5 countries
Study dates
1 Jan 2009to 2 Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 5 countries.

6 sites in 5 countries

Sweden2 sites

  • Department of Pediatrics, Drottning Sylvias Pediatric Hospital

    Gothenburg

  • NOPHO nordic organisation for pediatric onology

    Stockholm

Other trials in Sweden

Denmark1 site

  • Department of Pediatrics, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Iceland1 site

  • University Hospital Reykjavik, Iceland

    Reykjavik

Other trials in Iceland

Norway1 site

  • Trondheim University Hospital

    Trondheim

Other trials in Norway

About this study

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

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

Read the 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

Being tested
PEG Asparaginase at six weeks interval, PEG Asparaginase at two weeks interval
Keywords
acute lymphoblastic leukemia, child, PEG-Asparaginase, EFS, efficacy, childhood acute lymphoblastic leukemia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG Asparaginase at six weeks intervalDrug

    Also called Oncaspar (PEG-Asparaginase)

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

  • PEG Asparaginase at two weeks intervalDrug

    Also called Oncaspar (PEG-Asparaginase)

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

Study groups in NCT00819351
Study groupRoleWhat they receive
PEG-asparaginase 6 weeks intervalsExperimentalPEG-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.
Receives: Drug: PEG Asparaginase at six weeks interval
PEG-Asparaginase 2 weeks intervalsActive comparatorPEG-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.
Receives: Drug: PEG Asparaginase at two weeks interval

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

    Measured: 6 years

Secondary outcomes (1)

  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.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2009 (estimated)
  2. Study start1 Jan 2009
  3. Primary completion2 Mar 2016
  4. Study completion2 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00819351
Sponsor's protocol ID
NOPHO ALL2008 PEG Asparaginase
Status last verified
Apr 2017
First submitted
8 Jan 2009
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30978155

  • 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.

    PubMed 28660740

  • 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.

    PubMed 28258828

  • 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.

    PubMed 27451978

  • 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.

    PubMed 25418987

  • 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.

    PubMed 24428625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG Asparaginase at six weeks interval and PEG Asparaginase at two weeks interval in people with Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden, Denmark, Finland, Iceland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00819351, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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