Second Malignant Neoplasms After Childhood ALL Therapy

Acute Lymphoblastic Leukemia Clinical Trial

— PdL-SMN1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476462
• Other study ID #: PdL SMN Study 1
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: May 23, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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 overall survival.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Denmark	Kjeld Schmiegelow	Copenhagen

Sponsors (8)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of SMN subtypes	Pattern of the main groups of SMN and their clinical charactiristics	At 20 years from diagnosis	No
Primary	Overall survival by subtype	Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)	At 10 years from diagnosis of SMN	No
Primary	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	At 20 years from ALL diagnosis	No