The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04187248
• Collaborator: (none)
• Enrollment: 1,248
• Location: 1
• Actual Duration (Months): 104
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Asparaginase

Detailed Description

Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.

In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.

This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.

Study Design

• Study Type: Observational
• Actual Enrollment: 1248 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
• Actual Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Feb 28, 2016
• Actual Study Completion Date: Mar 1, 2017

Outcome Measures

Primary Outcome Measures

1. Number of participants with hypersensitivity [July 2008 - February 2016]

   Clinical allergy / silent inactivation.

2. Number of participants with asparaginase associated pancreatitis [July 2008 - February 2016]

3. Number of participants with tromboembolism [July 2008 - February 2016]

4. Number of participants with osteonecrosis [July 2008 - February 2016]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ALL, standard or intermediate risk

• Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)

• Children (1-17,9 years at diagnosis)

Exclusion Criteria:

• ALL: high risk disease, ph-, genetic predisposition, bilinear ALL

• < 2 samples for asparaginase enzyme activity measurements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Department of Pediatrics Skejby Hospital	Aarhus	Aarhus N	Denmark	8200

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Birgitte Klug Albertsen, M.D., PhD, Associate Professor, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT04187248
• Other Study ID Numbers: NOPHOALL2008_asp-tox
• First Posted: Dec 5, 2019
• Last Update Posted: Dec 6, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Asparaginase

Study Results

No Results Posted as of Dec 6, 2019