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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01281735




Registration number
NCT01281735
Ethics application status
Date submitted
14/01/2011
Date registered
24/01/2011
Date last updated
17/01/2024

Titles & IDs
Public title
International Chronic Myeloid Leukemia Pediatric Study
Scientific title
INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents
Secondary ID [1] 0 0
2010-023359-27
Secondary ID [2] 0 0
CIC1402
Universal Trial Number (UTN)
Trial acronym
ICMLPed
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* patients less than 18 years of age
* diagnosed Philadelphia positive and/or BCR-ABL positive Chronic Myeloid Leukemia (CML) all phases
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients more than 18 years of age at diagnosis of CML

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belarus
State/province [2] 0 0
Minsk
Country [3] 0 0
Belgium
State/province [3] 0 0
Ghent
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
China
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Croatia
State/province [7] 0 0
Zagreb
Country [8] 0 0
Czechia
State/province [8] 0 0
Prague
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
France
State/province [10] 0 0
Poitiers
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Greece
State/province [12] 0 0
Athen
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Lebanon
State/province [14] 0 0
Beirut
Country [15] 0 0
Netherlands
State/province [15] 0 0
Utrecht
Country [16] 0 0
Poland
State/province [16] 0 0
Wroclaw
Country [17] 0 0
Slovakia
State/province [17] 0 0
Bratislava
Country [18] 0 0
Spain
State/province [18] 0 0
Palma de Mallorca
Country [19] 0 0
Turkey
State/province [19] 0 0
Görükle

Funding & Sponsors
Primary sponsor type
Other
Name
Poitiers University Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CIC Inserm 1402
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Milano Bicocca
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Medical Center Groningen
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Liege
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Imperial College London
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University Hospital Dresden
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
International BFM Study Group
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.
Trial website
https://clinicaltrials.gov/study/NCT01281735
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Frederic MILLOT, MD
Address 0 0
Poitiers University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Frederic MILLOT, MD
Address 0 0
Country 0 0
Phone 0 0
+33 (0)5 49 44 30 78
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01281735