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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171158
First Posted: September 15, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
September 12, 2005
September 15, 2005
February 23, 2017
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 ]
Not Provided
Complete list of historical versions of study NCT00171158 on ClinicalTrials.gov Archive Site
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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
Intervention Model: Single Group Assignment
Masking: None (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:

Other protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   United States
United Kingdom
 
NCT00171158
CSTI571A0102E2
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

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