BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).
Leukemia, Myeloid, Chronic-phase
Leukemia, Lymphoblastic, Acute, Philadelphia-positive
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia|
- Establishment of MTD and recommended Phase II dose.
- 1) Hematologic Response 2) Cytogenetic Response.
|Study Start Date:||November 2003|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
Other Name: Sprycel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103701
|United States, California|
|Los Angeles, California, United States|
|United States, Texas|
|Houston, Texas, United States|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|