A Phase 3 Randomized, Open-Label Study Of Bosutinib Versus Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1

Outcome Description:

Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed.

Outcome Time Frame:

Year 1

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A4-3000

NCT ID:

NCT00574873

Start Date:

February 2008

Completion Date:

September 2014

Related Keywords:

• Chronic Myeloid Leukemia
• Bosutinib
• imatinib
• CML
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome