Outcome Following Truncation of Asparag… | Clinical Trial

Key information

Conditions

Relapse Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Department of Pediatrics Skejby Hospital

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016.

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

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Birgitte Klug Albertsen

Other

Registry information

Official study title

Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol

Important dates

Study start: 2008
Primary completion: 2020
Study completion: 2020
First posted: Jun 17, 2019
Registry last updated: May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed