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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
Argentina
Hospital Italiano Recruiting
Buenos Aires, Argentina
Contact: Eduardo DIBAR, Prof.       eduardo.dibar@hiba.org.ar   
Principal Investigator: Eduardo DIBAR, MD         
Australia, South Australia
Women's and children's Hospital Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Heather TAPP, Prof.       heather.tapp@health.sa.gov.au   
Principal Investigator: Heather TAPP, MD         
Austria
Children's Cancer Research Institute Recruiting
Vienna, Austria, 1090
Contact: Mchael DWORZAK, Prof.       michael.dworzak@ccri.at   
Principal Investigator: Michael DWORZAK, MD         
Belarus
National Research Center for Pediatric Oncology and Hematology Recruiting
Minsk, Belarus
Contact: Natalia SAVVA, MD       n_savva@yahoo.com   
Principal Investigator: Natalia SAVVA, MD         
Belgium
University of Liege Recruiting
Liege, Belgium, 4000
Contact: Marie Françoise DRESSE, Prof.       marie-francoise.dresse@chrcitadelle.be   
Principal Investigator: Marie Françoise DRESSE, MD         
Sub-Investigator: Barbara DE MOERLOOSE, PhD         
Sub-Investigator: Alice FERSTER         
Sub-Investigator: Marlies BEKAERT         
Brazil
Instituto de Oncologia Pediatrica Recruiting
Sao Paulo, Brazil, 04023-062
Contact: Maria Lucia LEE, MD       mlucialee@ig.com.br   
Principal Investigator: Maria Lucia LEE, MD         
Chile
Hospital Roberto Del Rio Recruiting
Santiago, Chile
Contact: Myriam CAMPBELL BULL, MD       myriamcampbellb@gmail.com   
Principal Investigator: Myriam CAMPBELL BULL, MD         
China
Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Li CHI KONG, Prof.       ckli@cuhk.edu.hk   
Principal Investigator: Li CHI KONG, MD         
Croatia
Children's Hospital Zagreb Recruiting
Zagreb, Croatia
Contact: Gordana JAKOVLJEVIC    +385914600152    gordanajakovljevic@yahoo.com   
Principal Investigator: Gordana JAKOVLJEVIC         
Czechia
Charles University Motol Recruiting
Prague, Czechia
Contact: Petr SEDLACEK, PhD    +420 22443 6552    Petr.Sedlacek@fnmotol.cz   
Contact: Ales LUKS       ales.luks@lfmotol.cuni.cz   
Principal Investigator: Petr SEDLACEK, PHD         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Birgitte LAUSEN, MD    45 3545 8177    Birgitte.Lausen@rh.regionh.dk   
Principal Investigator: Birgitte LAUSEN, MD         
France
Clinical Investigation Center CIC 1402 Recruiting
Poitiers, France, 86021
Contact: Violaine GOYEAU, Master    +33 (0)5 49 44 30 57    violaine.goyeau@chu-poitiers.fr   
Contact: Joelle GUILHOT, PhD    +33 (0)5 49 44 46 89    j.guilhot@chu-poitiers.fr   
Principal Investigator: Frederic MILLOT, MD         
Germany
University Hospital Dresden Recruiting
Dresden, Germany, 01307
Contact: Meinolf SUTTORP, Prof.       meinolf.suttorp@uniklinikum-dresden.de   
Principal Investigator: Meinolf SUTTORP, MD         
Greece
Agia Sophia Children's Hospital Recruiting
Athen, Greece, 11527
Contact: Vassilios PAPADAKIS, MD       vpapadak@otenet.gr   
Principal Investigator: Vassilios PAPADAKIS, MD         
Japan
Keio University School of Medicine Recruiting
Tokyo, Japan, 160-8582
Contact: Shimada HIROYUKI, MD PhD       hshimada@a5.keio.jp   
Principal Investigator: Shimada HIROYUKI, MD PhD         
Lebanon
Saint George Hospital University Medical Centre Recruiting
Beirut, Lebanon
Contact: Farah ROULA, MD       roula.fs@dm.net.lb   
Principal Investigator: Farah ROULA         
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 AB
Contact: Eveline DE BONT, Prof.       e.de.bont@bkk.umcg.nl   
Principal Investigator: Eveline DE BONT, MD         
Poland
Wroclaw Medical University Department Recruiting
Wrocław, Poland
Contact: Krzysztof KALWAK, PhD    +48717703170    krzysztof.kalwak@gmail.com   
Contact: Malgorzata Janeczko       ml.janeczko@gmail.com   
Principal Investigator: Krzysztof KALWAK, PhD         
Slovakia
Faculty of Medicine Recruiting
Bratislava, Slovakia, 813 72
Contact: Emilia KAISEROVA, Prof       emilia.kaiserova@fmed.uniba.sk   
Principal Investigator: Emilia KAISEROVA, MD         
Turkey
Uludag University, Medical Faculty Recruiting
Görükle, Turkey
Contact: Adalet M GÜNEŞ, MD       adaletm@uludag.edu.tr   
Principal Investigator: Adalet M GÜNEŞ, MD         
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