Chronic Myeloid LeukemiaPhase 2NCT00866736
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
A Phase 2 study testing dasatinib in people with Chronic Myeloid Leukemia, run by Kanto CML Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 2
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed Written Informed Consent
- Subjects with chronic phase chronic myeloid leukemia (CML)
- Subjects resistant/intolerant to imatinib
- Subjects presenting:
- ECOG performance status (PS) score 0-2
- Adequate hepatic function
- Adequate renal function
- Adequate lung function
Who cannot join
- Concurrent malignancy other than CML
- Women who are pregnant or breastfeeding
- Concurrent pleural effusion
- Uncontrolled or significant cardiovascular disease
- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
- Prior therapy with dasatinib
- Subjects with T315I and/or F317L BCR-ABL point mutations
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
About this study
Official title: A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- dasatinib
- Keywords
- chronic myeloid leukemia, dasatinib, chronic phase myeloid leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
Also called BMS-354825
100mg QD
| Study group | Role | What they receive |
|---|---|---|
| dasatinib | Experimental | Not described Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
Measured: at 12 months
Secondary outcomes (5)
safety after treatment with dasatinib
Measured: 2 year
rate of Complete Cytogenetic Response(CCyR)
Measured: 2 year
rate of Complete Hematologic Response (CHR)
Measured: 2 year
efficacy on patients with BCR-ABL point mutations
Measured: 2 year
progression free survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanto CML Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Investigators
- Hisashi Sakamaki, MD.PhD, Principal investigator, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866736
- Sponsor's protocol ID
- KCSG-01
- Status last verified
- Dec 2010
- First submitted
- 18 Mar 2009
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204. doi: 10.3960/jslrt.54.197.
PubMed 25501110
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00866736
- Acronym / sponsor ID
- KCSG-01
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- chronic myeloid leukemia, dasatinib, chronic phase myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kanto CML Study GroupUniversity, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Mar 2009 (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 the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dasatinib | Experimental | Drug: dasatinib |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Written Informed Consent
- Subjects with chronic phase chronic myeloid leukemia (CML)
- Subjects resistant/intolerant to imatinib
- Subjects presenting:
Key exclusion criteria (7 listed)
- Concurrent malignancy other than CML
- Women who are pregnant or breastfeeding
- Concurrent pleural effusion
- Uncontrolled or significant cardiovascular disease
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dasatinibAlso: BMS-354825100mg QD | Drug | dasatinib |
Primary outcome
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
Time frame: at 12 months
5 secondary outcomes
safety after treatment with dasatinib
Time frame: 2 year
rate of Complete Cytogenetic Response(CCyR)
Time frame: 2 year
rate of Complete Hematologic Response (CHR)
Time frame: 2 year
efficacy on patients with BCR-ABL point mutations
Time frame: 2 year
progression free survival
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Derived from this study: PubMed 25501110Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204. doi: 10.3960/jslrt.54.197.
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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.
Hisashi Sakamaki, MD.PhD principal investigator
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dasatinib in people with Chronic Myeloid Leukemia, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 15 Sep 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects (time frame: at 12 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 NCT00866736, which also lists 1 linked publication.
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 15 Sep 2015.