An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Both
Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Trial Information
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Adult Patients With Ph + Leukemia
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To enable patients to have access to study drug and continue study treatment
Outcome Time Frame:
December 31, 2011
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSTI571A0109E2
NCT ID:
NCT00171249
Start Date:
August 2004
Completion Date:
April 2013
Related Keywords:
- Philadelphia Positive Chronic Myeloid Leukemia in Accelerated Phase, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Chronic Myelogenous Leukemia
- CML
- Philadelphia Chromosome
- Accelerated phase
- Acute Myelogenous Leukemia
- AML
- Acute Lymphoblastic Leukemia
- ALL
- Imatinib mesylate
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| Oregon Health & Sciences University | Portland, Oregon 97201 |
| New York Presbyterian Hospital | New York, New York 10021 |
| Dana Faber Cancer Institute | Boston, Massachusetts 02115 |
| MD Anderson Cancer Center, University of Texas | Houston, Texas 77030 |
