NCT04825548

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration 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, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

March 29, 2021

Last Update Submit

February 4, 2024

Conditions

Acute Lymphoblastic LeukemiaPost Thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of patients with post thrombotic syndrome

    01112020-01022023

Interventions

No interventionOTHER

Examination of patients with previous DVT

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients between 1.0-45 years of age and diagnosed with DVT and PE during treatment on the NOPHO ALL2008 protocol. In this period, 115 patients were diagnosed with DVT

You may qualify if:

  • Treated on the ALL2008 protocol for ALL. Had a DVT on treatment.

You may not qualify if:

  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Vælg En Region, Stat Eller Provins., 8200, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPostthrombotic Syndrome

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Design

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

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

July 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

DK(1)