Clinical trial NCT01464411: Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
Official title: Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelogenous Leukemia, Chronic, Chronic Phase
Keywords: chronic myelogenous leukemia
chronic phase
Phase II
dasatinib
Lead sponsor: Kanto CML Study Group
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of complete molecular response (CMR) after treatment with dasatinib
timeFrame: by 18 months
Secondary outcomes:
measure: complete molecular response (CMR)
timeFrame: by 3,6,12,24, 36 months
measure: Major Molecular Response(MMR)
timeFrame: by 3,6,12,18,24,36 months
measure: Complete Cytogenetic Response(CCyR)
timeFrame: by 6,12 months
measure: Expansions rate of large granular lymphocyte
timeFrame: by 12 months
measure: Progression free survival
timeFrame: at 36 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: by 36 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kanto CML Study Group
Study officials:
References:
citation: 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.
citation: 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.