Leukemia, Lymphoblastic, Acute, Philadelphia-positive, Leukemia, Myeloid, Chronic-phase
Conditions
Keywords
Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase, Philadelphia chromosome positive acute (Ph+ALL)
Brief summary
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).
Interventions
DRUGDasatinib
Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL. * Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate. * Men and women, 14 years of age or older. * Adequate renal function. * Adequate hepatic function. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
Exclusion criteria
* Patients who are eligible and willing to undergo transplantation during the screening period. * Women who are pregnant or breastfeeding. * A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy. * Uncontrolled or significant cardiovascular disease. * Medications that increase bleeding risk. * Medications that change heart rhythms. * Dementia or altered mental status that would prohibit the understanding of rendering of informed consent. * History of significant bleeding disorder or unrelated to CML. * Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishment of MTD and recommended Phase II dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Hematologic Response 2) Cytogenetic Response. | — |
Countries
United States
Outcome results
None listed