TDM of Asparaginase in ALL2008

Sponsor

Aarhus University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04843514

Collaborator

(none)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.

Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018.

From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future.

A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Outcome Measures

Primary Outcome Measures

Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on [2018-2021]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.

Exclusion Criteria:

No samples sent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Denmark	Aarhus N		Denmark	8200
2	Aarhus University Hospital	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:

NCT04843514

Other Study ID Numbers:

NOPHO-ALL2008-phamacokinetics

First Posted:

Apr 13, 2021

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Apr 13, 2021