A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

NCT01342679 | Completed Phase 2 DMC

• 1 other identifier: KCSG-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Myeloid Leukemia

Keywords

chronic myeloid leukemia; dasatinib; complete molecular response

Outcome Measures

Primary Outcomes (1)

• Rate of complete molecular response (CMR) after treatment with dasatinib

  at 12 months

Secondary Outcomes (4)

• Dasatinib of dose intensity

  at 12 months

• Expansions rate of large granular lymphocyte

  at 12 months

• Progression free survival

  at 12 months

• Number of Participants with Adverse Events

  at 12 months

Study Arms (1)

dasatinib

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

100mg QD

Also known as: BMS-354825

dasatinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Myeloid Leukemia in the Chronic Phase
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanto CML Study Group: lead
• Epidemiological and Clinical Research Information Network: collaborator

Study Sites (1)

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Chikashi Yoshida, MD, PhD

  National Hospital Organization, Mito Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2011-04

Locations

JP (1)