Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

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


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.

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

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039