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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis |
Drug: imatinib mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: imatinib mesylate |
Drug: imatinib mesylate
Other Name: Gleevec/Glivec
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171158
Locations
| United States, California | |
| UCLA | |
| Los Angeles, California, United States, 90059 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287-8985 | |
| United States, Massachusetts | |
| Dana Faber Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Wayne State University/Kamanos Cancer Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| France | |
| Novartis Investigative Site | |
| Poitiers, France | |
| Germany | |
| Novartis Investigative Site | |
| Frankfurt/Main, Germany | |
| Novartis Investigative Site | |
| Leipzig, Germany | |
| Novartis Investigative Site | |
| Mannheim, Germany | |
| Novartis Investigative Site | |
| Muenchen, Germany | |
| Italy | |
| Novartis Investigative Site | |
| Bologna, Italy | |
| Novartis Investigative Site | |
| Monza, Italy | |
| Novartis Investigative Site | |
| Roma, Italy | |
| United Kingdom | |
| Novartis Investigative Site | |
| London, United Kingdom, W12 0NN | |
| Novartis Investigative Site | |
| Newcastle upon Tyre, United Kingdom, NE1 4LP | |
| Novartis Investigative Site | |
| Nottingham, United Kingdom, NG5 1PB | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00171158 History of Changes |
| Other Study ID Numbers: | CSTI571A0102E2 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Chronic Myelogenous Leukemia CML Philadelphia Chromosome Blast crisis Imatinib mesylate |
Additional relevant MeSH terms:
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013