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An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia


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

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Trial Information

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia


Inclusion Criteria:



- Male & Female ≥18 years

- Chronic Phase Ph+ CML

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-2

Exclusion Criteria:

- Pleural Effusion

- Uncontrolled cardiovascular (CV) disease

- Significant bleeding disorder unrelated to CML

- Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments
except anagrelide/hydroxyurea

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:

Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months

Outcome Description:

Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A confirmed cytogenetic response (cCCyR)=those in which all measurements up to at least 28 days after the initial response show an equivalent or better cytogenetic response.

Outcome Time Frame:

Pre-treatment, every 3 months up to 12 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CA180-056

NCT ID:

NCT00481247

Start Date:

September 2007

Completion Date:

December 2013

Related Keywords:

  • Myeloid Leukemia, Chronic
  • Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease

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