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 is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171158
First received: September 12, 2005
Last updated: April 23, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | April 23, 2013 | ||||
| Start Date ICMJE | August 2004 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00171158 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis | ||||
| Intervention ICMJE | Drug: imatinib mesylate
Other Name: Gleevec/Glivec |
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| Study Arm (s) | Experimental: imatinib mesylate
Intervention: Drug: imatinib mesylate |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, France, Germany, Italy, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00171158 | ||||
| Other Study ID Numbers ICMJE | CSTI571A0102E2 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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