Phase 3 N=502 Randomized Treatment

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

Chronic Myeloid Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00574873 ↗

Enrolled (actual)

502

Serious AEs

29.5%

Results posted

Nov 2012

Primary outcome: Primary: Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1 — 70.0; 68.3 Percentage of Participants — p=0.667

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bosutinib (Drug); imatinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1	70.0; 68.3	0.667
SECONDARY Percentage of Participants With Major Molecular Response (MMR) at Year 1	38.0; 25.4	0.002 sig
SECONDARY Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks	92.9; 88.9	—
SECONDARY Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks	91.6; 86.0	—
SECONDARY Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks	94.7; 98.0	—
SECONDARY Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks	1.6; 4.4	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.