MedDataX Logo

A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

NCT ID: NCT02013102

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm Ⅰ

Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks.

Group Type EXPERIMENTAL

Decitabine Injection

Intervention Type DRUG

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.

Arm Ⅱ

Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.

Group Type EXPERIMENTAL

Decitabine Injection

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decitabine Injection

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

qingweike

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cttq

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shao Zonghong, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liu Hui, MD

Role: CONTACT

Phone: 0086-022-60362636

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

LIU HUI, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DREAM-201

Identifier Type: -

Identifier Source: org_study_id