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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866736
• Other study ID #: KCSG-01
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2009
• Last updated: September 14, 2015
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: December 2010
• Source: Kanto CML Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• dasatinib
100mg QD

Locations

Country	Name	City	State
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Bunkyo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Kanto CML Study Group	Epidemiological and Clinical Research Information Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects		at 12 months	No
Secondary	safety after treatment with dasatinib		2 year	Yes
Secondary	rate of Complete Cytogenetic Response(CCyR)		2 year	No
Secondary	rate of Complete Hematologic Response (CHR)		2 year	No
Secondary	efficacy on patients with BCR-ABL point mutations		2 year	No
Secondary	progression free survival		2 year	No