Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

Conditions

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

Keywords

chronic myelogenous leukemia, chronic phase, Phase II, dasatinib

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.

Chikashi Yoshida, Noriyoshi Iriyama, Yuho Najima, Shin Fujisawa, Hisashi Wakita et al. (19 authors)

Blood2016-12-027 citations

10.1182/blood.v128.22.1916.1916

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

Noriyoshi Iriyama, Shin Fujisawa, Chikashi Yoshida, Hisashi Wakita, Shigeru Chiba et al. (18 authors)

American Journal of Hematology2015-06-2335 citations

10.1002/ajh.24096

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 <scp>K</scp>anto CML study group

Noriyoshi Iriyama, Shin Fujisawa, Chikashi Yoshida, Hisashi Wakita, Shigeru Chiba et al. (18 authors)

American Journal of Hematology2014-12-2247 citations

10.1002/ajh.23923

The Incidence of Pleural Effusion on Dasatinib Treatment Is Associated with CD56 Positive Cell Values One Month after Commencing Dasatinib and Achievement of an Early Molecular Response in Newly Diagnosed Chronic Myeloid Leukemia Patients: Results of a D-First Study

Noriyoshi Iriyama, Shin Fujisawa, Maki Hagihara, Chikashi Yoshida, Hisashi Wakita et al. (19 authors)

Blood2014-12-061 citations

10.1182/blood.v124.21.3142.3142

A Shorter Halving Time for BCR-ABL transcript Reduction Is a Novel Predictor of Molecular Response Achievement in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP) Patients Treated with Dasatinib: Results of D-First Study

Maki Hagihara, Noriyoshi Iriyama, Chikashi Yoshida, Shin Fujisawa, Hisashi Wakita et al. (19 authors)

Blood2014-12-06

10.1182/blood.v124.21.1795.1795

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Months to No maximum

Healthy volunteers

No

Inclusion criteria

* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase * 20 years old over * ECOG performance status (PS) score 0-2 * Adequate organ function (hepatic, renal and lung) * Signed written informed consent

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 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

Design outcomes

Primary

Measure	Time frame	Description
Rate of complete molecular response (CMR) after treatment with dasatinib	by 18 months	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.

Secondary

Measure	Time frame
Major Molecular Response(MMR)	by 3,6,12,18,24,36 months
Complete Cytogenetic Response(CCyR)	by 6,12 months
complete molecular response (CMR)	by 3,6,12,24, 36 months
Progression free survival	at 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	by 36 months
Expansions rate of large granular lymphocyte	by 12 months

Countries

Japan

Contacts

Primary ContactTakashi Kumagai, M.D, Ph.D

kumamed1_2001@yahoo.co.jp81-428-22-3191

Backup ContactHisashi Sakamaki, M.D, Ph.D

sakamaki-h@cick.jp81-3-3823-2101

Outcome results