Childhood Acute Lymphoblastic Leukaemia: Follow-Up

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT03545659
• Date of registration: 17/05/2018
• Prospective Registration: Yes
• Primary sponsor: University of Aarhus
• Public title: Childhood Acute Lymphoblastic Leukaemia: Follow-Up
• Scientific title: Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study
• Date of first enrolment: September 4, 2018
• Target sample size: 277
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03545659
• Study type: Observational

Countries of recruitment

Denmark, Finland, Iceland, Norway, Sweden

Contacts

• Name: Henrik Schrøder, Professor
• Affiliation: Aarhus University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway,
Finland or Iceland)

- included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials

- treated in a Paediatric Department

- developing a relapse/SMN after cessation of maintenance therapy before 31st of
December 2016

Exclusion Criteria:

- hematopoietic stem cell transplantation in first complete remission



Age minimum: 1 Year
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Recurrence

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention(s)

Other: Mode of relapse/SMN detection

Primary Outcome(s)

Detection mode [Time Frame: Investigators will review medical charts up to three months before the diagnosis of a relapse. Relapses will be categorized to be diagnosed by either a routine visit or an extra scheduled visit.]

Secondary Outcome(s)

Survival [Time Frame: Time-to-Event measures (up to 23 years from date of relapse until censoring)]

Secondary ID(s)

ALL-Relapse

Source(s) of Monetary Support

Please refer to primary and secondary sponsors