Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcome Following Truncation of Asparaginase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03987542
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Birgitte Klug Albertsen, Aarhus University Hospital

Brief Summary:
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.

Condition or disease
Relapse Leukemia

Detailed Description:

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1248 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
Actual Study Start Date : July 2008
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Exposed
Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity.
Unexposed
Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children aged 1-17.9 years at time of diagnosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987542


Contacts
Layout table for location contacts
Contact: Birgitte Klug Albertsen, MD., PhD, Associate Professor 004520224643 biralber@rm.dk

Locations
Layout table for location information
Denmark
Aarhus University Hospital, Department of Pediatrics Skejby Hospital Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Birgitte K Albertsen, MD    +45 8949 6841    biralber@rm.dk   
Principal Investigator: Birgitte K Albertsen, MD         
Sponsors and Collaborators
Birgitte Klug Albertsen

Layout table for additonal information
Responsible Party: Birgitte Klug Albertsen, M.D., PhD, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03987542     History of Changes
Other Study ID Numbers: Asparaginase_truncation_NOPHO
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Birgitte Klug Albertsen, Aarhus University Hospital:
Acute lymphoblastic leukemia
Asparaginase
Truncation
Toxicitities

Additional relevant MeSH terms:
Layout table for MeSH terms
Asparaginase
Antineoplastic Agents