An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171249
First received: September 12, 2005
Last updated: March 21, 2014
Last verified: March 2014

September 12, 2005
March 21, 2014
August 2004
September 2013   (final data collection date for primary outcome measure)
To enable patients to have access to study drug and continue study treatment [ Time Frame: December 31, 2011 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00171249 on ClinicalTrials.gov Archive Site
Not Provided
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An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia

This extension II study will allow for further follow-up of the disease under treatment with imatinib mesylate and allow the patients to continue to receive imatinib mesylate.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Drug: imatinib mesylate
Experimental: Gleevec/Glivec
Intervention: Drug: imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of the CSTI571A0109E1 study
  • Written informed consent for the extension CSTI571A0109E2

Exclusion Criteria:

- none

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   United Kingdom
 
NCT00171249
CSTI571A0109E2
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP