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Second Malignant Neoplasms After Childhood ALL Therapy

Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01476462
Acronym
PdL-SMN1
Enrollment
642
Registered
2011-11-22
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemia, Ponte-di-Legno consortium, Second cancer, Survival

Brief 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 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.

Interventions

None listed

Sponsors

Nordic Society for Pediatric Hematology and Oncology
CollaboratorOTHER
European Organisation for Research and Treatment of Cancer - EORTC
CollaboratorNETWORK
Dana-Farber Cancer Institute
CollaboratorOTHER
ALL-BFM Study Group
CollaboratorNETWORK
Dutch Childhood Oncology Group
CollaboratorOTHER
St. Jude Children's Research Hospital
CollaboratorOTHER
United Kingdom Children's Cancer Study Group
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with childhood acute lymphoblastic leukemia * Diagnosis of second cancer before December 31st 2007

Exclusion criteria

* Uncertainty if the second cancer has emerged from the same original leukemic clone

Design outcomes

Primary

MeasureTime frameDescription
Pattern of SMN subtypesAt 20 years from diagnosisPattern of the main groups of SMN and their clinical charactiristics
Overall survival by subtypeAt 10 years from diagnosis of SMNOverall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
Risk factors for development of SMNAt 20 years from ALL diagnosisIdentification 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026