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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

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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 Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Cedar Rapids, Iowa  52403
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Santa Fe, New Mexico  87505
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Livingston, New Jersey  07039