An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171158
First received: September 12, 2005
Last updated: March 25, 2014
Last verified: March 2014

September 12, 2005
March 25, 2014
August 2004
April 2013   (final data collection date for primary outcome measure)
To enable patients to have access to study drug and continue treatment [ Time Frame: until no patients are left on study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00171158 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 Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Patients (Male or Female ≥18 Years) With Ph + CML in Blast Crisis

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 Myeloid Blast Crisis
Drug: imatinib mesylate
Other Name: Gleevec/Glivec
Experimental: imatinib mesylate
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
20
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of the CSTI571A0102E1 study
  • Written informed consent for the extension CSTI571A0102E2

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,   Germany,   France,   Italy
 
NCT00171158
CSTI571A0102E2
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