NCT01464411

Brief Summary

The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
Last Updated

November 3, 2011

Status Verified

November 1, 2011

First QC Date

September 18, 2011

Last Update Submit

November 2, 2011

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelogenous Leukemia, Chronic, Chronic Phase

Keywords

chronic myelogenous leukemiachronic phasePhase IIdasatinib

Outcome Measures

Primary Outcomes (1)

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

    The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.

    by 18 months

Secondary Outcomes (6)

  • complete molecular response (CMR)

    by 3,6,12,24, 36 months

  • Major Molecular Response(MMR)

    by 3,6,12,18,24,36 months

  • Complete Cytogenetic Response(CCyR)

    by 6,12 months

  • Expansions rate of large granular lymphocyte

    by 12 months

  • Progression free survival

    at 36 months

  • +1 more secondary outcomes

Eligibility Criteria

Age20 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan

You may qualify if:

  • Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
  • years old over
  • ECOG performance status (PS) score 0-2
  • 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 whithin 6 months
  • have an Angina within 3 months
  • have a Congestive heart failure within 3 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanto CML Study Group

Tokyo, Japan

RECRUITING

Related Publications (2)

  • Iriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Early cytotoxic lymphocyte expansion contributes to a deep molecular response to dasatinib in patients with newly diagnosed chronic myeloid leukemia in the chronic phase: results of the D-first study. Am J Hematol. 2015 Sep;90(9):819-24. doi: 10.1002/ajh.24096.

    PMID: 26103598DERIVED

  • Iriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Shorter halving time of BCR-ABL1 transcripts is a novel predictor for achievement of molecular responses in newly diagnosed chronic-phase chronic myeloid leukemia treated with dasatinib: Results of the D-first study of Kanto CML study group. Am J Hematol. 2015 Apr;90(4):282-7. doi: 10.1002/ajh.23923. Epub 2015 Mar 2.

    PMID: 25530131DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Copy numbers of bcr-abl mRNA in patients with dasatinib treatment will be measured by real-time RT-PCR to evaluate the efficiency of dasatinib. For patients resistant to dasatinib therapy, DNA mutation analysis of the bcr-abl gene associated with drug-resistancy will be performed.

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Takashi Kumagai, M.D, Ph.D

CONTACT

81-428-22-3191kumamed1_2001@yahoo.co.jp

Hisashi Sakamaki, M.D, Ph.D

CONTACT

81-3-3823-2101sakamaki-h@cick.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D

Study Record Dates

First Submitted

September 18, 2011

First Posted

November 3, 2011

Study Start

July 1, 2011

Last Updated

November 3, 2011

Record last verified: 2011-11

Locations

JP(1)