A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

— DREAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013102
• Other study ID #: DREAM-201
• Status: Recruiting
• Phase: Phase 4
• First received: December 9, 2013
• Last updated: December 11, 2013
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Cttq
• Contact: Liu Hui, MD
• Phone: 0086-022-60362636
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Cttq

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-4 months	Yes