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International Chronic Myeloid Leukemia Pediatric Study (ICMLPed)

This study is currently recruiting participants.
Verified October 2017 by Poitiers University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281735
First Posted: January 24, 2011
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Center Groningen
University Hospital of Liege
Imperial College London
University Hospital Dresden
International BFM Study Group
Information provided by (Responsible Party):
Poitiers University Hospital
  Purpose
The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

Condition
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Estimated Enrollment: 750
Study Start Date: January 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients less than 18 years of age with newly diagnosed Philadelphia positive and/or bcr-abl positive CML are eligible whatever the phase of the disease, the type of treatment and the enrollment or not in a clinical study.
Criteria

Inclusion Criteria:

  • patients less than 18 years of age
  • diagnosed Philadelphia positive and/or BCR-ABL positive Chronic Myeloid Leukemia (CML) all phases

Exclusion Criteria:

  • patients more than 18 years of age at diagnosis of CML
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281735


Contacts
Contact: Frederic MILLOT, MD +33 (0)5 49 44 30 78 f.millot@chu-poitiers.fr

  Show 20 Study Locations
Sponsors and Collaborators
Poitiers University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Center Groningen
University Hospital of Liege
Imperial College London
University Hospital Dresden
International BFM Study Group
Investigators
Principal Investigator: Frederic MILLOT, MD Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01281735     History of Changes
Other Study ID Numbers: CIC09-33
2010-023359-27 ( EudraCT Number )
First Submitted: January 14, 2011
First Posted: January 24, 2011
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Poitiers University Hospital:
treatment outcome
side effects
Protein Kinase Inhibitors
pediatrics

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases