A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

Kanto CML Study Group

Status and phase: Completed; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00866736

KCSG-01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.

Enrollment: 65 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Written Informed Consent

• Subjects with chronic phase chronic myeloid leukemia (CML)

• Subjects resistant/intolerant to imatinib

• Subjects presenting:

  1. ECOG performance status (PS) score 0-2
  2. Adequate hepatic function
  3. Adequate renal function
  4. Adequate lung function

Exclusion criteria

• Concurrent malignancy other than CML
• Women who are pregnant or breastfeeding
• Concurrent pleural effusion
• Uncontrolled or significant cardiovascular disease
• A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
• Prior therapy with dasatinib
• Subjects with T315I and/or F317L BCR-ABL point mutations

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

dasatinib

Experimental group

Treatment:

Drug: dasatinib