International study on Chronic Myeloid Leukemia in children
INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents
This study looks at children and teens with Chronic Myeloid Leukemia to learn more about their treatment outcomes and side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Drugs / interventions | imatinib |
| Locations | 20 sites (North Adelaide, South Australia and 19 other locations) |
| Trial ID | NCT01281735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe and characterize Chronic Myeloid Leukemia (CML) in a large cohort of pediatric patients. It focuses on children and adolescents diagnosed with Philadelphia positive and/or BCR-ABL positive CML, collecting data on treatment outcomes and side effects. The study is conducted internationally, involving multiple institutions to gather comprehensive epidemiological information that is currently lacking in this age group. By documenting the characteristics of CML in children, the study seeks to improve understanding and management of this rare disease.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents under 18 years of age diagnosed with Chronic Myeloid Leukemia.
Not a fit: Patients diagnosed with CML over the age of 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of CML in pediatric patients, leading to better treatment strategies and outcomes.
How similar studies have performed: While there have been limited studies on CML in children, this approach is novel in its comprehensive international data collection.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
North Adelaide, South Australia and 19 other locations
- Women's and children's Hospital — North Adelaide, South Australia, Australia (Not_yet_recruiting)
- St. Anna Children's Cancer Research Institute and St. Anna Children's Hospital — Vienna, Austria (Recruiting)
- Belarussian Reseach Center for Pediatric Oncology and hematology (BRCPOH) — Minsk, Belarus (Recruiting)
- University Hospital of Ghent — Ghent, Belgium (Recruiting)
- Instituto de Oncologia Pediatrica — São Paulo, 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, Denmark (Recruiting)
- Clinical Investigation Center CIC 1402 — Poitiers, France (Recruiting)
- University Hospital Dresden — Dresden, Germany (Recruiting)
- Agia Sophia Children's Hospital — Athens, Greece (Recruiting)
- Keio University School of Medicine — Tokyo, 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, Slovakia (Recruiting)
- Officina Proyectos SEHOP — Palma de Mallorca, Spain (Recruiting)
- Uludag University, Medical Faculty — Görükle, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Frederic MILLOT, MD — Poitiers University Hospital
- Study coordinator: Frederic MILLOT, MD
- Email: f.millot@chu-poitiers.fr
- Phone: +33 (0)5 49 44 30 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.