A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

NCT02013102 | Unknown Phase 4 DMC

• 1 other identifier: DREAM-201
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm Ⅰ

EXPERIMENTAL

Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks.

Drug: Decitabine Injection

Arm Ⅱ

EXPERIMENTAL

Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.

Drug: Decitabine Injection

Interventions

Decitabine Injection DRUG

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.

Also known as: qingweike

Arm Ⅰ; Arm Ⅱ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cttq: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Shao Zonghong, MD

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Hui, MD

CONTACT

0086-022-60362636

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

CN (1)