Childhood Acute Lymphoblastic Leukaemia: Follow-Up

NCT ID: NCT03545659

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 277 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2021-01-20

Brief Summary

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.

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Mode of relapse/SMN detection

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Schrøder, Professor

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus N, , Denmark

Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Turku, , Finland

The National University Hospital of Iceland

Reykjavik, , Iceland

Department of Childhood Oncology, University Hospital Tromsø

Tromsø, , Norway

Department of Paediatric Oncology, Karolinska University Hospital

Stockholm, , Sweden

Countries

Denmark; Finland; Iceland; Norway; Sweden

Other Identifiers

ALL-Relapse

Identifier Type: -

Identifier Source: org_study_id