Pediatric Chronic Myeloid Leukemia Registry (PCMLR)
This study is currently recruiting participants.
Verified February 2011 by Poitiers University Hospital
Sponsor:
Poitiers University Hospital
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Centre Groningen
University Hospital of Liege
Imperial College London
University Hospital Dresden
International BFM Study Group
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01281735
First received: January 14, 2011
Last updated: February 7, 2011
Last verified: February 2011
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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 2016 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281735
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Contacts
| Contact: Frederic MILLOT, MD | +33 (0)5 49 44 30 78 | f.millot@chu-poitiers.fr |
Hide Study LocationsLocations
| 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 | |
| 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 | |
| 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 0802 | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Sophie ZIN-KA-IEU, PhD +33 (0)5 49 44 30 57 sophie.zin-ka-ieu@chu-poiters.fr | |
| Contact: Joelle GUILHOT, MSc +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 | |
| Italy | |
| University of Milano-Bicocca | Recruiting |
| Milano, Italy, 20126 | |
| Contact: Andrea BIONDI, MD abiondi.unimib@gmail.com | |
| Principal Investigator: Andrea BIONDI, 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 | |
| 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 | |
| Slovakia | |
| Faculty of Medicine | Recruiting |
| Bratislava, Slovakia, 813 72 | |
| Contact: Emilia KAISEROVA, Prof emilia.kaiserova@fmed.uniba.sk | |
| Principal Investigator: Emilia KAISEROVA, MD | |
| United Kingdom | |
| Imperial college Healthcare | Recruiting |
| London, United Kingdom, W2 | |
| Principal Investigator: Josu DE LA FUENTE, MD | |
Sponsors and Collaborators
Poitiers University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
University of Milano Bicocca
University Medical Centre 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
No publications provided
| Responsible Party: | MILLOT, Clinical investigation center CIC 0802 |
| ClinicalTrials.gov Identifier: | NCT01281735 History of Changes |
| Other Study ID Numbers: | CIC09-33, 2010-023359-27 |
| Study First Received: | January 14, 2011 |
| Last Updated: | February 7, 2011 |
| Health Authority: | France: French Data Protection Authority |
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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013