A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome (DREAM)

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.

Study Overview

• Status: Unknown
• Conditions: Myelodysplastic Syndrome
• Intervention / Treatment: Drug: Decitabine Injection

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: LIU HUI, MD
      • Principal Investigator: Shao Zonghong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm Ⅰ; Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks.	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.; Other Names: qingweike
EXPERIMENTAL: Arm Ⅱ; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.	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.; Other Names: qingweike

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cttq
• Investigators: Principal Investigator: Shao Zonghong, MD, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (ESTIMATE): December 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: DREAM-201