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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00171223
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: Novartis Pharmaceuticals
Public title: An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
Scientific title: An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
Date of first enrolment: August 2004
Target sample size: 356
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00171223
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
France Germany Italy Switzerland United Kingdom United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion criteria

Inclusion Criteria:

- Successful completion of the CSTI571A 0110 E1 study

- Written informed consent for the extension CSTI571A0110E2

Exclusion Criteria:

- none

Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Intervention(s)
Drug: imatinib mesylate
Primary Outcome(s)
To enable patients to continue to have access to study treatment [Time Frame: December 31, 2011]
Secondary Outcome(s)
Secondary ID(s)
CSTI571A0110E2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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