Myelodysplastic SyndromePhase 4DREAMNCT02013102
A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome
A Phase 4 study testing Decitabine Injection in people with Myelodysplastic Syndrome, run by Cttq at 1 site in China.
Trial summary
The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Decitabine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Age≥18;
- The diagnosis of MDS patients comply WHO2008 standards;
- IPSS score≥0.5;
- WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
- ECOG PS score: 0-2;
- Expected survival≥3 months;
- Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;
- Subjects signed informed consent form in line with GCP requirements.
Who cannot join
- Can not marrow biopsy;
- Previously diagnosed AML;
- Received azacitidine or decitabine treatment any time before;
- Being diagnosed with other malignancies in the prior 12 months;
- Pregnant or lactating women;
- Failure to control systemic fungal, bacterial or viral infection;
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- Known or suspected allergy to decitabine;
- Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;
- Have a history of neurological or psychiatric disorders, including epilepsy or dementia;
- CTCAE 3 or 4 degree peripheral neuropathy;
- According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;
- Using other experimental drugs or participating in other clinical trials in the prior one months.
Trial locations and contacts
1 site in 1 country.
Liu Hui, MD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
LIU HUI, MD
Shao Zonghong, MD
About this study
Official title: A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome
The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Read the detailed description
Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Decitabine Injection
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine InjectionDrug
Also called qingweike
Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm Ⅰ | Experimental | Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks. Receives: Drug: Decitabine Injection |
| Arm Ⅱ | Experimental | Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. Receives: Drug: Decitabine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cttq
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shao Zonghong, MD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013102
- Sponsor's protocol ID
- DREAM-201
- Acronym
- DREAM
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02013102
- Acronym / sponsor ID
- DREAM / DREAM-201
- Conditions
- Myelodysplastic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CttqIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Dec 2013 (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 of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Detailed description
Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Ⅰ | Experimental | Drug: Decitabine InjectionDecitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks. |
| Arm Ⅱ | Experimental | Drug: Decitabine InjectionDecitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age≥18;
- The diagnosis of MDS patients comply WHO2008 standards;
- IPSS score≥0.5;
- WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
- ECOG PS score: 0-2;
Key exclusion criteria (12 listed)
- Can not marrow biopsy;
- Previously diagnosed AML;
- Received azacitidine or decitabine treatment any time before;
- Being diagnosed with other malignancies in the prior 12 months;
- Pregnant or lactating women;
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 |
|---|---|---|
| Decitabine InjectionAlso: qingweikeDecitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. | Drug | Arm Ⅰ, Arm Ⅱ |
Primary outcome
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Time frame: 2-4 months
The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Liu Hui, MD contact
Shao Zonghong, MD principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Decitabine Injection in people with Myelodysplastic Syndrome, run by Cttq at 1 site in China.
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 12 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 17 Dec 2013. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liu Hui, MD (0086-022-60362636), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome. (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2013.