Chronic Myelogenous Leukemia
Conditions
Keywords
Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL
Brief summary
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Interventions
DRUGDasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Inclusion criteria
* Philadelphia chromosome positive or bcr-abl gene positive * Chronic Myelogenous Leukemia (CML) * Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate * Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL) * Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy * Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2 * Men and women, ages 20 - 75 * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Exclusion criteria
* Subjects who are eligible and willing to undergo transplantation at pre-study * Women who are pregnant or breastfeeding * Uncontrolled or significant cardiovascular disease * History of significant bleeding disorder unrelated to CML or ALL * Adequate hepatic function * Adequate renal function * Medication that increase bleeding risk * Medication that change heart rhythms * Subjects who are compulsorily detained for legal reasons or 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 |
|---|---|
| Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response | — |
| response | — |
Countries
Japan
Outcome results
None listed