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An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Phase Chronic Myeloid Leukemia

Thank you

Trial Information

An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib


Inclusion Criteria:



- CP-CML Philadelphia chromosome positive (Ph+) patients with CHR but with BCR-ABL
level > 10% IS after 3 months of Imatinib 400 mg treatment. Imatinib monotherapy must
have been started within 3 months of CP-CML diagnosis

- Currently tolerating Imatinib 400 mg QD

- Eastern Co-Operative Group (ECOG) performance status = 0 - 2

- Adequate renal function defined as serum creatinine ≤ 3 times the institutional upper
limit of normal (ULN)

- Adequate hepatic function defined as:

- Total Bilirubin ≤ 2.0 times institutional ULN

- Alanine Aminotransferase (ALT) ≤ 2.5 times the institutional ULN

- Aspartate Aminotransferase (AST) ≤ 2.5 times the institutional ULN

- Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or
equal to the institutional lower limit of normal

Exclusion Criteria:

- Accelerated Phase (AP)/ blast crisis (BP) diagnosis

- Not in Complete Hematologic Response (CHR) by 3 month

- Documented T315I mutation

- Prior Chronic Myeloid Leukemia (CML) treatment other than Imatinib

- Serious, uncontrolled Medical condition

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects who achieve Major Molecular Response (MMR) rate

Outcome Time Frame:

At 12 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-399

NCT ID:

NCT01593254

Start Date:

September 2012

Completion Date:

July 2019

Related Keywords:

  • Chronic Phase Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Tennessee Oncology, PLLCClarksville, Tennessee  37043