Precursor Cell Lymphoblastic Leukemia-LymphomaNCT03545659
Childhood Acute Lymphoblastic Leukaemia: Follow-Up
An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma and Recurrence, run by University of Aarhus at 5 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
- What is being tested?
- Mode of relapse/SMN detection
- How many people
- 277 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 Sep 2018to 20 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
Study population: The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.
Who may be able to join
- 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
Who cannot join
- hematopoietic stem cell transplantation in first complete remission
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Denmark1 site
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus N, 8200
Finland1 site
Department of Paediatrics and Adolescent Medicine, Turku University Hospital
Turku, 20521
Norway1 site
Department of Childhood Oncology, University Hospital Tromsø
Tromsø, 9038
Sweden1 site
Department of Paediatric Oncology, Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: 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.
Read the 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.
- Being tested
- Mode of relapse/SMN detection
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of relapse/SMN detectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection mode
The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.
Measured: 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 outcomes (1)
Survival
Survival, by detection mode (routine or extra visit)
Measured: Time-to-Event measures (up to 23 years from date of relapse until censoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start4 Sep 2018
- Primary completion30 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Schrøder, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545659
- Sponsor's protocol ID
- ALL-Relapse
- Status last verified
- Jun 2020
- First submitted
- 17 May 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study
- ClinicalTrials.gov ID
- NCT03545659
- Acronym / sponsor ID
- ALL-Relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- hematopoietic stem cell transplantation in first complete remission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mode of relapse/SMN detectionMode 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Survival
Time frame: Time-to-Event measures (up to 23 years from date of relapse until censoring)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Schrøder, Professor study director
Aarhus University Hospital
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma and Recurrence, run by University of Aarhus at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Finland, Iceland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.