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Second Malignant Neoplasms After Childhood ALL Therapy (PdL-SMN1)

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01476462
First received: July 13, 2011
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pattern of SMN subtypes [ Time Frame: At 20 years from diagnosis ] [ Designated as safety issue: No ]
    Pattern of the main groups of SMN and their clinical charactiristics

  • Overall survival by subtype [ Time Frame: At 10 years from diagnosis of SMN ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 642
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476462

Locations
Denmark
Kjeld Schmiegelow
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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
Investigators
Principal Investigator: Kjeld Schmiegelow, M.D. Rigshospitalet, Denmark
Principal Investigator: Maria G Valsecchi, M.Sci, Dipartimento di medicina clinica e prevenzione, University of Milan, Italy
  More Information

No publications provided

Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01476462     History of Changes
Other Study ID Numbers: PdL SMN Study 1
Study First Received: July 13, 2011
Last Updated: May 23, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Acute lymphoblastic leukemia
Ponte-di-Legno consortium
Second cancer
Survival

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013