NCT04187248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

7.7 years

First QC Date

December 3, 2019

Last Update Submit

August 23, 2023

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (4)

  • Number of participants with hypersensitivity

    Clinical allergy / silent inactivation.

    July 2008 - February 2016

  • Number of participants with asparaginase associated pancreatitis

    July 2008 - February 2016

  • Number of participants with tromboembolism

    July 2008 - February 2016

  • Number of participants with osteonecrosis

    July 2008 - February 2016

Interventions

AsparaginaseDRUG

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with ALL, aged 1-17.9 years at time of diagnosis

You may qualify if:

  • ALL, standard or intermediate risk
  • Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
  • Children (1-17,9 years at diagnosis)

You may not qualify if:

  • ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
  • \< 2 samples for asparaginase enzyme activity measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Pediatrics Skejby Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD, Associate Professor

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

July 1, 2008

Primary Completion

February 28, 2016

Study Completion

March 1, 2017

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)