Myelodysplastic SyndromeNCT01041846
A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndrome, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who signed the subject informed consent form among the patients with myelodysplastic syndrome who were treated with decitabine
Who may be able to join
- Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including chronic myelomonocytic leukemia (CMML) with an International Prognostic Scoring System more than or equal to Interferon-1
- Patients who have never treated with hypomethylating agent (azacitidine and decitabine)
- Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations.
- Women of childbearing potential should conduct an effective method of birth control as defined in protocol, in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
Who cannot join
- Patients diagnosed with acute myelogenous leukemia (bone marrow stem cell counts exceeding 20 %) or other progressive malignant diseases
- Patients with active infection of virus or bacteria
- Patients who used to be treated with azacitidine or decitabine
- Patients who are hypersensitive to excipients of decitabine
- Patients who are pregnant and breast-feeding
About this study
Official title: A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.
Read the detailed description
This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- No intervention
- Keywords
- Myelodysplastic Syndrome, Dacogen, Decitabine, Epigenetic therapy, Hypomethylating agent
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete remission
The complete response includes the evaluations of Bone marrow aspiration and biopsy (less than or equal to 5 percents myeloblast), persistent dysplasia and peripheral blood.
Measured: Up to 61 days
Number of patients with partial remission
The partial response includes all complete remission evaluating parameters with the exception of bone marrow blasts are decreased by more than or equal to 50 percents over pretreatment but still more than 5 percents and cellularity (the state of a tissue or other mass as regards the number of its constituent cells) and morphology (examination of structure)
Measured: Up to 61 days
Number of patients with hematological improvement
Measured: Up to 61 days
Response rate
Response rate is the combination of complete remission, partial remission and hematological improvement and performed according to the response criteria of 'International Working Group 2006' which is standardized criteria for assessing response are essential to ensure comparability among clinical trials for patients with MDS.
Measured: After 4 cycles and end of treatment
Secondary outcomes (5)
Cytogenetic response rate
Measured: Up to 61 days
Overall survival rate
Overall survival will be evaluated from the registration day to death.
Measured: Up to 61 days
Time to acute myeloid leukemia evolution
The time of progression from myelodysplastic syndromes to acute myeloid leukemia.
Measured: Up to 61 days
Number of patients with progression-free survival status
Hospitalization or undergoes surgical procedure due to disease progression.
Measured: Up to 61 days
Number of patients with adverse event
Measured: Up to 61 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionJul 2010
- Study completionJul 2010
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 Myelodysplastic SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041846
- Sponsor's protocol ID
- CR015895
- Other IDs
- DECKOR5002
- Status last verified
- Jul 2013
- First submitted
- 17 Dec 2009
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27.
PubMed 31375393Lee JH, Jang JH, Park J, Park S, Joo YD, Kim YK, Kim HG, Choi CW, Kim SH, Park SK, Park E, Min YH. A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome. Haematologica. 2011 Oct;96(10):1441-7. doi: 10.3324/haematol.2011.046078. Epub 2011 Jun 9.
PubMed 21659363
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01041846
- Acronym / sponsor ID
- CR015895
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic Syndrome, Dacogen, Decitabine, Epigenetic therapy, Hypomethylating agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Jan 2010 (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 effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.
Detailed description
This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine | – | Drug: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who signed the subject informed consent form among the patients with myelodysplastic syndrome who were treated with decitabine
Key inclusion criteria (4 listed)
- Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including chronic myelomonocytic leukemia (CMML) with an International Prognostic Scoring System more than or equal to Interferon-1
- Patients who have never treated with hypomethylating agent (azacitidine and decitabine)
- Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations.
- Women of childbearing potential should conduct an effective method of birth control as defined in protocol, in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
Key exclusion criteria (5 listed)
- Patients diagnosed with acute myelogenous leukemia (bone marrow stem cell counts exceeding 20 %) or other progressive malignant diseases
- Patients with active infection of virus or bacteria
- Patients who used to be treated with azacitidine or decitabine
- Patients who are hypersensitive to excipients of decitabine
- Patients who are pregnant and breast-feeding
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 |
|---|---|---|
| No interventionThis is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed. | Drug | Decitabine |
Primary outcome
Number of patients with complete remission
Time frame: Up to 61 days
The complete response includes the evaluations of Bone marrow aspiration and biopsy (less than or equal to 5 percents myeloblast), persistent dysplasia and peripheral blood.
Number of patients with partial remission
Time frame: Up to 61 days
The partial response includes all complete remission evaluating parameters with the exception of bone marrow blasts are decreased by more than or equal to 50 percents over pretreatment but still more than 5 percents and cellularity (the state of a tissue or other mass as regards the number of its constituent cells) and morphology (examination of structure)
Number of patients with hematological improvement
Time frame: Up to 61 days
Response rate
Time frame: After 4 cycles and end of treatment
Response rate is the combination of complete remission, partial remission and hematological improvement and performed according to the response criteria of 'International Working Group 2006' which is standardized criteria for assessing response are essential to ensure comparability among clinical trials for patients with MDS.
5 secondary outcomes
Cytogenetic response rate
Time frame: Up to 61 days
Overall survival rate
Time frame: Up to 61 days
Time to acute myeloid leukemia evolution
Time frame: Up to 61 days
Number of patients with progression-free survival status
Time frame: Up to 61 days
Number of patients with adverse event
Time frame: Up to 61 days
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 29 Jul 2013.
- Derived from this study: PubMed 31375393Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27.
- Derived from this study: PubMed 21659363Lee JH, Jang JH, Park J, Park S, Joo YD, Kim YK, Kim HG, Choi CW, Kim SH, Park SK, Park E, Min YH. A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome. Haematologica. 2011 Oct;96(10):1441-7. doi: 10.3324/haematol.2011.046078. Epub 2011 Jun 9.
- A Prospective, Multicenter, Observational Study of Dacogen Treatment in Patients with Myelodysplastic SyndromeLink provided by the sponsor.
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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.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Janssen Korea, Ltd., Korea.
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 4 inclusion and 5 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of patients with complete remission (time frame: Up to 61 days). The study lists 4 primary outcomes in all. 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 NCT01041846, 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 29 Jul 2013.