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A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Chronic Phase Chronic Myeloid Leukemia

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Trial Information

A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib


Inclusion Criteria:



- Patients with CML-CP patients achieving an optimal response to imatinib treatment
with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or
recurring at least 3 times in the preceding 12 months, despite best supportive care

- Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18

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

- Patient willing and able to give informed consent

- Life expectancy > 6 months

- Adequate renal function

- Adequate hepatic function

Exclusion Criteria:

- Patients who are pregnant or breast feeding

- Men whose partner is unwilling to avoid pregnancy.

- Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for
imatinib

- Current grade 3 or 4 imatinib related adverse event

- Prior documented T315I mutation

- Prior diagnosis of accelerated phase or blast crisis CML

- Previous loss of complete hematologic response (CHR) or major cytogenetic response
(MCyR) on imatinib

- Concurrent medical condition of uncontrolled infection, cardiovascular diseases of
cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT
interval, second or third degree heart block, uncontrolled angina, myocardial
infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial
hypertension, pleural or pericardial effusions, or history of bleeding disorder

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of reduction in grade (Grade 2 to 1) or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs at 3 months after switch to dasatinib

Outcome Time Frame:

3 months after switch to dasatinib

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA180-400

NCT ID:

NCT01660906

Start Date:

December 2012

Completion Date:

September 2014

Related Keywords:

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

Name

Location

Pacific Cancer Medical CenterAnaheim, California  92801
Cancer Center of Central ConnecticutSouthington, Connecticut