Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1401 participants
OBSERVATIONAL
2008-07-31
2020-06-30
Brief Summary
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Detailed Description
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The most frequent toxicities causing asparaginase truncations are hypersensitivity, pancreatitis and thrombosis. Especially hypersensitivity constitutes a problem due to silencing antibodies, not only in patients with clinical hypersensitivity but also in patients without clinical symptoms (silent inactivation).
In the NOPHO ALL2008 protocol asparaginase associated toxicities and truncation of asparaginase have been registered since the protocol opened in 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
The primary aim of this study was to investigate if patients with truncation of asparaginase or lack of asparaginase enzyme activity had a different risk of relapse compared to patients who received full asparaginase treatment. Secondary we aimed to explore if patients who received less than 50% of their planned asparaginase dosages had a different risk of relapse compared to those who received 50% or more.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Exposed
Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity.
No interventions assigned to this group
Unexposed
Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Birgitte Klug Albertsen
OTHER
Responsible Party
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Birgitte Klug Albertsen
M.D., PhD, Associate Professor
Locations
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Aarhus University Hospital, Department of Pediatrics Skejby Hospital
Aarhus, Aarhus N, Denmark
Countries
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References
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Gottschalk Hojfeldt S, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jonsson OG, Frandsen TL, Wolthers BO, Marquart HV, Vaitkeviciene G, Lepik K, Heyman M, Schmiegelow K, Albertsen BK. Relapse risk following truncation of pegylated asparaginase in childhood acute lymphoblastic leukemia. Blood. 2021 Apr 29;137(17):2373-2382. doi: 10.1182/blood.2020006583.
Other Identifiers
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Asparaginase_truncation_NOPHO
Identifier Type: -
Identifier Source: org_study_id
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