Childhood Acute Lymphoblastic Leukaemia: Follow-Up

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Intervention / Treatment: Other: Mode of relapse/SMN detection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 277

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
• Finland
  • Turku, Finland, 20521
    • Department of Paediatrics and Adolescent Medicine, Turku University Hospital
• Iceland
  • Reykjavík, Iceland, 101
    • The National University Hospital of Iceland
• Norway
  • Tromsø, Norway, 9038
    • Department of Childhood Oncology, University Hospital Tromsø
• Sweden
  • Stockholm, Sweden, 171 76
    • Department of Paediatric Oncology, Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection mode	The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.	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 Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival, by detection mode (routine or extra visit)	Time-to-Event measures (up to 23 years from date of relapse until censoring)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Henrik Schrøder, Professor, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia; Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: ALL-Relapse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No