Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030718

CA180-036

Details and patient eligibility

About

To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Enrollment: 54 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject

Exclusion criteria

• Women who are pregnant or breastfeeding
• Subjects who are eligible and willing to undergo transplantation at pre-study
• Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)

Trial design

54 participants in 3 patient groups

dasatinib (CML-CP)

Experimental group

Description:

CML - Chronic Phase

Treatment:

Drug: dasatinib

dasatinib (CML-AP/BP)

Experimental group

Description:

CML - Accelerated Phase and Blast Phase

Treatment:

Drug: dasatinib

dasatinib (Ph+ ALL)

Experimental group

Description:

Ph+ Acute Lymphoblastic Leukemia

Treatment:

Drug: dasatinib