Childhood Acute Lymphoblastic Leukaemia: Follow-Up

Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce.

The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.

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Key information

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus N, Denmark

About this study

Investigators have identified a cohort of children with B-precursor ALL and T-ALL enrolled in the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-92, ALL-2000 and ALL-2008 trials and experienced a relapse or an SMN as the first event after cessation of maintenance therapy (368 patients). From medical charts and blood test results it will be decided whether the relapse/SMN was diagnosed at a routine visit (including routine blood tests) or if the relapse was diagnosed because of symptoms at a non-scheduled visit or blood test.

As the NOPHO database probably is one of the most complete databases globally, it is an advantage to perform this study as a NOPHO study.

Results of this population based relapse study will provide an evidence-based background for planning optimal and relevant follow-up programs for children after therapy of ALL treated according to contemporary Nordic ALL protocols.

The study is important and relevant in the light of today's high ALL cure rates and a need for optimal follow-up programs after cessation of ALL treatment and possible prediction of relapse.

The timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mode of relapse/SMN detection

Other

Mode of relapse/SMN detection: whether the relapse/SMN was diagnosed because of symptoms of leukaemia or diagnosed at a routine visit in the outpatient clinic.

Primary outcomes

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.

The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.

Secondary outcomes

Survival

Time frame: Time-to-Event measures (up to 23 years from date of relapse until censoring)

Survival, by detection mode (routine or extra visit)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Jun 4, 2018
Registry last updated: Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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