A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib (CMR-CML)

Kanto CML Study Group

Status and phase: Completed; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01342679

KCSG-02

Details and patient eligibility

About

The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

Enrollment: 21 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Myeloid Leukemia in the Chronic Phase
• 20 years old over
• ECOG performance status (PS) score 0-2
• Patients for major molecular response (MMR) with no CMR
• Adequate organ function (hepatic, renal and lung)
• Signed written informed consent

Exclusion criteria

• A case with the double cancer of the activity

• Women who are pregnant or breastfeeding

• The case of Pleural effusion clearly

• Patients with complications or a history of severe or uncontrolled cardiovascular failure following

  • have a Myocardial infarction within 6 months
  • have an Angina within 3 months
  • have a Congestive heart failure within 3 months
  • have a suspected congenital QT syndrome
  • have a QTc interval of more than 450msec at baseline

• A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

• Prior treatment with dasatinib

• Subjects with T315I, F317L and V299L BCR-ABL point mutations

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

dasatinib

Experimental group

Treatment:

Drug: dasatinib