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
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis
Both
Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis
Trial Information
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
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.
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 treatment
Outcome Time Frame:
until no patients are left on study
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSTI571A0102E2
NCT ID:
NCT00171158
Start Date:
August 2004
Completion Date:
April 2014
Related Keywords:
- Philadelphia Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis
- Chronic Myelogenous Leukemia
- CML
- Philadelphia Chromosome
- Blast crisis
- Imatinib mesylate
- Blast Crisis
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| University of North Carolina | Chapel Hill, North Carolina 27599 |
| University of Chicago | Chicago, Illinois 60637 |
| UCLA | Los Angeles, California 90095 |
| Johns Hopkins Hospital | Baltimore, Maryland 21287 |
| Dana Faber Institute | Boston, Massachusetts 02115 |
| Wayne State University/Kamanos Cancer Center | Detroit, Michigan 48201 |
