Acute Lymphoblastic LeukemiaPdL-SMN1NCT01476462
Second Malignant Neoplasms After Childhood ALL Therapy
An observational study of Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 642 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Dec 2011
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study cohort includes all registered cases of second cancers occurring as the first event among children diagnosed with acute lymphoblastic leukemia and treated according to protocol by one of the collaborative groups participating in the present study
Who may be able to join
- Diagnosed with childhood acute lymphoblastic leukemia
- Diagnosis of second cancer before December 31st 2007
Who cannot join
- Uncertainty if the second cancer has emerged from the same original leukemic clone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study
Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.
Read the detailed description
To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute lymphoblastic leukemia, Ponte-di-Legno consortium, Second cancer, Survival
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALL diagnosed 1980-2007 | Cases of childhood acute lymphoblastic leukemia (ALL) diagnosed between 1980 and 2007 and included in the clinical trials of the participating ALL study groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of SMN subtypes
Pattern of the main groups of SMN and their clinical charactiristics
Measured: At 20 years from diagnosis
Overall survival by subtype
Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
Measured: At 10 years from diagnosis of SMN
Risk factors for development of SMN
Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered
Measured: At 20 years from ALL diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology, European Organisation for Research and Treatment of Cancer - EORTC, Dana-Farber Cancer Institute, ALL-BFM Study Group, Dutch Childhood Oncology Group, St. Jude Children's Research Hospital, United Kingdom Children's Cancer Study Group
- Responsible party
- Principal investigator, Kjeld Schmiegelow, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kjeld Schmiegelow, M.D., Principal investigator, Copenhagen University Hospital, RigshospitaletMaria G Valsecchi, M.Sci,, Principal investigator, Dipartimento di medicina clinica e prevenzione, University of Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476462
- Sponsor's protocol ID
- PdL SMN Study 1
- Acronym
- PdL-SMN1
- Status last verified
- May 2012
- First submitted
- 13 Jul 2011
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study
- ClinicalTrials.gov ID
- NCT01476462
- Acronym / sponsor ID
- PdL-SMN1 / PdL SMN Study 1
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute lymphoblastic leukemia, Ponte-di-Legno consortium, Second cancer, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology, European Organisation for Research and Treatment of Cancer - EORTC, Dana-Farber Cancer Institute, ALL-BFM Study Group, Dutch Childhood Oncology Group, St. Jude Children's Research Hospital, United Kingdom Children's Cancer Study Group
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.
Detailed description
To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL diagnosed 1980-2007 | – | –Cases of childhood acute lymphoblastic leukemia (ALL) diagnosed between 1980 and 2007 and included in the clinical trials of the participating ALL study groups |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study cohort includes all registered cases of second cancers occurring as the first event among children diagnosed with acute lymphoblastic leukemia and treated according to protocol by one of the collaborative groups participating in the present study
Key inclusion criteria (2 listed)
- Diagnosed with childhood acute lymphoblastic leukemia
- Diagnosis of second cancer before December 31st 2007
Key exclusion criteria (1 listed)
- Uncertainty if the second cancer has emerged from the same original leukemic clone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pattern of SMN subtypes
Time frame: At 20 years from diagnosis
Pattern of the main groups of SMN and their clinical charactiristics
Overall survival by subtype
Time frame: At 10 years from diagnosis of SMN
Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
Risk factors for development of SMN
Time frame: At 20 years from ALL diagnosis
Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered
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 24 May 2012.
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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.
Kjeld Schmiegelow, M.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
Maria G Valsecchi, M.Sci, principal investigator
Dipartimento di medicina clinica e prevenzione, University of Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Pattern of SMN subtypes (time frame: At 20 years from diagnosis). The study lists 3 primary outcomes in all. 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 24 May 2012.