PdL-SMN1: Second Malignant Neoplasms After Childhood ALL Therapy

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01476462

Collaborator

Nordic Society for Pediatric Hematology and Oncology (Other), European Organisation for Research and Treatment of Cancer - EORTC (Other), Dana-Farber Cancer Institute (Other), ALL-BFM Study Group (Other), Dutch Childhood Oncology Group (Other), St. Jude Children's Research Hospital (Other), United Kingdom Children's Cancer Study Group (Other)

642

Enrollment

Location

Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia

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

Study Type:

Observational

Actual Enrollment :

642 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Pattern of SMN subtypes [At 20 years from diagnosis]
Pattern of the main groups of SMN and their clinical charactiristics
Overall survival by subtype [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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