Skip to main content
OpenTrials
Completed

NCT Number: NCT01476462

Second Malignant Neoplasms After Childhood ALL Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Second Primary Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kjeld Schmiegelow

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pattern of SMN subtypes

    Time frame: At 20 years from diagnosis

    Pattern of the main groups of SMN and their clinical charactiristics

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: PdL-SMN1

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
May 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.