Leukemia, Myelogenous, Chronic, BCR-ABL PositiveD-FirstNCT01464411
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
An observational study of Leukemia, Myelogenous, Chronic, BCR-ABL Positive and Myelogenous Leukemia, Chronic, Chronic Phase, run by Kanto CML Study Group at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 months and older
- Conditions the study is for
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kanto CML Study Group
Tokyo
Hisashi Sakamaki, M.D, Ph.D, 81-3-3823-2101, sakamaki-h@cick.jp
Takashi Kumagai, M.D, Ph.D, 81-428-22-3191, kumamed1_2001@yahoo.co.jp
About this study
Official title: Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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.
- Conditions
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase
- Keywords
- chronic myelogenous leukemia, chronic phase, Phase II, dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: by 18 months
Secondary outcomes (6)
complete molecular response (CMR)
Measured: by 3,6,12,24, 36 months
Major Molecular Response(MMR)
Measured: by 3,6,12,18,24,36 months
Complete Cytogenetic Response(CCyR)
Measured: by 6,12 months
Expansions rate of large granular lymphocyte
Measured: by 12 months
Progression free survival
Measured: at 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: by 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myelogenous, Chronic, BCR-ABL PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanto CML Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takashi Kumagai, Kanto CML Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464411
- Sponsor's protocol ID
- KCSG-03
- Acronym
- D-First
- Status last verified
- Nov 2011
- First submitted
- 18 Sep 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26103598Iriyama 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.
PubMed 25530131
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
- ClinicalTrials.gov ID
- NCT01464411
- Acronym / sponsor ID
- D-First / KCSG-03
- Conditions
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase
- Keywords
- chronic myelogenous leukemia, chronic phase, Phase II, dasatinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kanto CML Study GroupUniversity, hospital or other
- Study start
- Jul 2011
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of complete molecular response (CMR) after treatment with dasatinib
Time frame: 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.
6 secondary outcomes
complete molecular response (CMR)
Time frame: by 3,6,12,24, 36 months
Major Molecular Response(MMR)
Time frame: by 3,6,12,18,24,36 months
Complete Cytogenetic Response(CCyR)
Time frame: by 6,12 months
Expansions rate of large granular lymphocyte
Time frame: by 12 months
Progression free survival
Time frame: at 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: by 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
- Derived from this study: PubMed 26103598Iriyama 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.
- Derived from this study: PubMed 25530131Iriyama 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myelogenous, Chronic, BCR-ABL Positive and Myelogenous Leukemia, Chronic, Chronic Phase, run by Kanto CML Study Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takashi Kumagai, M.D, Ph.D (81-428-22-3191, kumamed1_2001@yahoo.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete molecular response (CMR) after treatment with dasatinib (time frame: by 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2011.