Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Myeloid Leukemia, Chronic, Accelerated Phase; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00123487

CA180-035

Details and patient eligibility

About

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Enrollment: 638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
• Men and women, 18 years of age or older
• Adequate hepatic function
• Adequate renal 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
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2

Exclusion Criteria:

• 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 or rendering of informed consent
• History of significant bleeding disorder unrelated to CML
• Concurrent incurable malignancy other than CML
• Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
• Prior therapy with BMS-35425
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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638 participants in 2 patient groups

dasatinib Twice a Day (BID)

Experimental group

Description:

70 mg dasatinib twice a day (BID)

Treatment:

Drug: dasatinib

Drug: dasatinib

dasatinib Once a Day (QD)

Experimental group

Description:

140 mg dasatinib once a day (QD)

Treatment:

Drug: dasatinib

Drug: dasatinib