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CompletedNCT01342679CMR-CMLUpdated Sep 15, 2015

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

A Phase 2 interventional study of dasatinib in Chronic Myeloid Leukemia, sponsored by Kanto CML Study Group. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Kanto CML Study Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Myeloid Leukemia

Keywords

  • chronic myeloid leukemia
  • dasatinib
  • complete molecular response
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 21 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Kanto CML Study Group is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    dasatinib

    Drug: dasatinib

Interventions

  • Drugdasatinib

    100mg QD

    Also known as: BMS-354825

06

What researchers measure

Primary outcomes

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

    Time frame: at 12 months

Secondary outcomes

  1. Dasatinib of dose intensity

    Time frame: at 12 months

  2. Expansions rate of large granular lymphocyte

    Time frame: at 12 months

  3. Progression free survival

    Time frame: at 12 months

  4. Number of Participants with Adverse Events

    Time frame: at 12 months

07

Study locations

1 site
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
    Bunkyo-ku, Tokyo 113-8677, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01342679
Lead sponsor
Kanto CML Study Group
Collaborators
Epidemiological and Clinical Research Information Network
First posted
Apr 27, 2011
Start date
Apr 2011
Primary completion
Mar 2013
Completion
Sep 2014
Last update
Sep 15, 2015

Study contacts

Chikashi Yoshida, MD, PhD
principal investigator · National Hospital Organization, Mito Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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