Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Pfizer

Status and phase: Completed; Phase 3

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: imatinib; Drug: Bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574873

2007-003780-50 (EudraCT Number)

B1871008 (Other Identifier)

3160A4-3000

Details and patient eligibility

About

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
• Diagnosis of CML chronic phase confirmed.
• Adequate hepatic and renal function.
• Able to take oral tablets.

Exclusion criteria

• Exclusions include Philadelphia negative CML.
• Prior anti-leukemia treatment.
• Prior stem cell transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

1

Experimental group

Description:

Bosutinib

Treatment:

Drug: Bosutinib

2

Active Comparator group

Description:

Imatinib

Treatment:

Drug: imatinib