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

Phase 2

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: dasatinib

• Registration Number: NCT00866736
• Lead Sponsor: Kanto CML Study Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Status Verified: 2010-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dasatinib	dasatinib	-

Primary Outcome Measures

Name	Time	Method
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects	at 12 months

Secondary Outcome Measures

Name	Time	Method
progression free survival	2 year
safety after treatment with dasatinib	2 year
rate of Complete Cytogenetic Response(CCyR)	2 year
rate of Complete Hematologic Response (CHR)	2 year
efficacy on patients with BCR-ABL point mutations	2 year

Trial Locations

Locations (1)

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital; 🇯🇵 Bunkyo-ku, Tokyo, Japan