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

Primary Purpose

Myelodysplastic Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Decitabine Injection
Sponsored by
Cttq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm Ⅰ

Arm Ⅱ

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2013
Last Updated
December 11, 2013
Sponsor
Cttq
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1. Study Identification

Unique Protocol Identification Number
NCT02013102
Brief Title
A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome
Acronym
DREAM
Official Title
A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cttq

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm Ⅰ
Arm Type
Experimental
Arm Description
Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks.
Arm Title
Arm Ⅱ
Arm Type
Experimental
Arm Description
Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Decitabine Injection
Other Intervention Name(s)
qingweike
Intervention Description
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.
Primary Outcome Measure Information:
Title
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Description
The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Hui, MD
Phone
0086-022-60362636
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao Zonghong, MD
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIU HUI, MD
First Name & Middle Initial & Last Name & Degree
Shao Zonghong, MD

12. IPD Sharing Statement

Learn more about this trial

A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

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