NCT04843150

Brief Summary

Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase. The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

April 9, 2021

Last Update Submit

February 4, 2024

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants with hypersensitivity Clinical allergy / silent inactivation

    Patients with allergic reactions or silent inactivation

    2018-2021

Eligibility Criteria

Age1 Year - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients with ALL 1-45 years of age treated on the ALLTOGETHER pilot protocol in the Nordic and Baltic countries.

You may qualify if:

  • Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, Skejby Hospital

Aarhus, 8200, Denmark

Location

Aarhus University Hospital, Denmark

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Birgitte K Albertsen, MD

    M.D., PhD, Associate Professor, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

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

April 9, 2021

First Posted

April 13, 2021

Study Start

July 1, 2020

Primary Completion

September 30, 2023

Study Completion

October 1, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

DK(2)