Phase 3
Completed N=502
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Source: ClinicalTrials.gov NCT00574873 ↗Enrolled (actual)
502
Serious AEs
29.5%
Results posted
Nov 2012
Primary outcomePrimary: Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1 — 70.0; 68.3 Percentage of Participants — p=0.667
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.
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 | — |
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.
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. Informational only — not medical advice.