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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT01281735
Trial related presentations / publications
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/ct2/show/NCT01281735