International Chronic Myeloid Leukemia Pediatric Study

NCT01281735 | Recruiting DMC

• 2 other identifiers: CIC14022010-023359-27
• Study Type: observational
• Target: 750
• Locations: 18 countries
• Sites: 18

Brief Summary

The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

Conditions

Chronic Myeloid Leukemia

Keywords

treatment outcome; side effects; Protein Kinase Inhibitors; pediatrics

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• patients more than 18 years of age at diagnosis of CML

Sponsors & Collaborators

• Poitiers University Hospital: lead
• CIC Inserm 1402: collaborator
• University of Milano Bicocca: collaborator
• University Medical Center Groningen: collaborator
• University of Liege: collaborator
• Imperial College London: collaborator
• University Hospital Dresden: collaborator
• International BFM Study Group: collaborator

Study Sites (20)

Women's and children's Hospital

North Adelaide, South Australia, 5006, Australia

NOT YET RECRUITING

St. Anna Children's Cancer Research Institute and St. Anna Children's Hospital

Vienna, 1090, Austria

RECRUITING

Belarussian Reseach Center for Pediatric Oncology and hematology (BRCPOH)

Minsk, Belarus

RECRUITING

University Hospital of Ghent

Ghent, 9000, Belgium

RECRUITING

Instituto de Oncologia Pediatrica

São Paulo, 04023-062, Brazil

RECRUITING

Hospital Roberto Del Rio

Santiago, Chile

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, China

RECRUITING

Children's Hospital Zagreb

Zagreb, Croatia

RECRUITING

Charles University Motol

Prague, Czechia

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Clinical Investigation Center CIC 1402

Poitiers, 86021, France

RECRUITING

University Hospital Dresden

Dresden, 01307, Germany

RECRUITING

Agia Sophia Children's Hospital

Athens, 11527, Greece

RECRUITING

Keio University School of Medicine

Tokyo, 160-8582, Japan

NOT YET RECRUITING

Saint George Hospital University Medical Centre

Beirut, Lebanon

RECRUITING

Dutch Childhood Oncology Group, Princess Maxima Center for pediatric oncology

Utrecht, Netherlands

RECRUITING

Wroclaw Medical University Department

Wroclaw, Poland

RECRUITING

University Children's Hospital

Bratislava, 813 72, Slovakia

RECRUITING

Officina Proyectos SEHOP

Palma de Mallorca, Spain

RECRUITING

Uludag University, Medical Faculty

Görükle, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Millot F, De Keizer J, Metzler M, Kalwak K, Gunes AM, De Moerloose B, Luesink M, Honrubia AM, Sedlacek P, Yajima J, Ampatzidou M, Dworzak M, Lausen B, Borisevich M, Li CK, Kolenova A, Jakovljevic G, Farah R, Durocher L, Baruchel A, Suttorp M. Children with chronic phase chronic myeloid leukemia: characteristics and outcomes from the International Registry of Childhood CML. Haematologica. 2025 Oct 23. doi: 10.3324/haematol.2025.288283. Online ahead of print.

  PMID: 41126742 DERIVED

• Meyran D, Petit A, Guilhot J, Suttorp M, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, de Moerloose B, Biondi A, Millot F. Lymphoblastic predominance of blastic phase in children with chronic myeloid leukaemia treated with imatinib: A report from the I-CML-Ped Study. Eur J Cancer. 2020 Sep;137:224-234. doi: 10.1016/j.ejca.2020.06.024. Epub 2020 Aug 13.

  PMID: 32799036 DERIVED

• Millot F, Maledon N, Guilhot J, Gunes AM, Kalwak K, Suttorp M. Favourable outcome of de novo advanced phases of childhood chronic myeloid leukaemia. Eur J Cancer. 2019 Jul;115:17-23. doi: 10.1016/j.ejca.2019.03.020. Epub 2019 May 10.

  PMID: 31082688 DERIVED

• Millot F, Guilhot J, Suttorp M, Gunes AM, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, Dworzak M, Kaiserova E, De Moerloose B, Roula F, Biondi A, Baruchel A. Prognostic discrimination based on the EUTOS long-term survival score within the International Registry for Chronic Myeloid Leukemia in children and adolescents. Haematologica. 2017 Oct;102(10):1704-1708. doi: 10.3324/haematol.2017.170035. Epub 2017 Aug 24.

  PMID: 28838993 DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederic MILLOT, MD

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic MILLOT, MD

CONTACT

+33 (0)5 49 44 30 78; f.millot@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

GR (1); SL (1); CZ (1); CN (1); BE (1); PL (1); DE (1); LE (1); ES (1); JP (1); BR (1); AU (1); DK (1); FR (1); TU (1); CL (1); CR (1); NL (1)