A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02013102

Acronym

DREAM

Enrollment

240

Registered

2013-12-17

Start date

2013-03-31

Completion date

2015-12-31

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Brief summary

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.

Interventions

DRUGDecitabine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.	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.

Countries

China

Contacts

Primary ContactLiu Hui, MD

0086-022-60362636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026