A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

Phase 4

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: Decitabine Injection

• Registration Number: NCT02013102
• Lead Sponsor: Cttq

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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Ⅰ	Decitabine Injection	Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks.
Arm Ⅱ	Decitabine Injection	Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China