An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171249
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 Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia |
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 Adult Patients With Ph + Leukemia |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To enable patients to have access to study drug and continue study treatment [ Time Frame: December 31, 2011 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gleevec/Glivec | Drug: imatinib mesylate |
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 CSTI571A0109E1 study
- Written informed consent for the extension CSTI571A0109E2
Exclusion Criteria:
- none
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171249
Locations
| United States, Massachusetts | |
| Dana Faber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| United States, Oregon | |
| Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| MD Anderson Cancer Center, University of Texas | |
| Houston, Texas, United States, 77030 | |
| France | |
| Novartis Investigative Site | |
| Pessac, France | |
| Novartis Investigative Site | |
| Poitiers, France | |
| Germany | |
| Novartis Investigative Site | |
| Frankfurt, Germany | |
| Novartis Investigative Site | |
| Leipzig, Germany | |
| Novartis Investigative Site | |
| Mainz, Germany | |
| Novartis Investigative Site | |
| Mannheim, Germany | |
| Italy | |
| Novartis Investigative Site | |
| Monza, Italy | |
| United Kingdom | |
| Novartis Investigative Site | |
| London, United Kingdom | |
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: | NCT00171249 History of Changes |
| Other Study ID Numbers: | CSTI571A0109E2 |
| 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 Accelerated phase Acute Myelogenous Leukemia |
AML Acute Lymphoblastic Leukemia ALL Imatinib mesylate |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases 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