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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04825548
Other study ID # PTS-NOPHOALL2008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL. Treatment related severe acute toxicities are common. Especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (PTS) or pulmonary hypertension. The knowledge about these late effects is limited, including for ALL patients.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria: - Treated on the ALL2008 protocol for ALL. Had a DVT on treatment. Exclusion Criteria: - Death

Study Design


Intervention

Other:
No intervention
Examination of patients with previous DVT

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N Vælg En Region, Stat Eller Provins.

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with post thrombotic syndrome 01112020-01022023
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