Outcome Following Truncation of Asparaginase
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|ClinicalTrials.gov Identifier: NCT03987542|
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
|Condition or disease|
Overall survival for children with ALL is now above 90% in several protocols, but asparaginase associated toxicities still constitutes a significant problem as they, besides causing acute morbidity and mortality, can cause truncation of treatment with a subsequent increased risk of relapse.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1248 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol|
|Actual Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity.
Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity
- Risk of relapse [ Time Frame: 5 years ]Do patients with truncation of asparaginase treatment or no enzyme activity (truncated) have a different risk of relapse compared to patients who have not been truncated and who have measurable enzyme activity (non-truncated)
- 50% of asparagine doses [ Time Frame: 5 years ]Do patients who receive less than 50% of their planned asparaginase dosages have a different risk of relapse compared to those who receive 50% or more.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987542
|Contact: Birgitte Klug Albertsen, MD., PhD, Associate Professoremail@example.com|
|Aarhus University Hospital, Department of Pediatrics Skejby Hospital||Recruiting|
|Aarhus, Aarhus N, Denmark, 8200|
|Contact: Birgitte K Albertsen, MD +45 8949 6841 firstname.lastname@example.org|
|Principal Investigator: Birgitte K Albertsen, MD|