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An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome

NCT01751867 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2016-04-05

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.

Conditions

Interventions

DRUG

Decitabine at 15 mg/m2

Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.

DRUG

Decitabine at 20 mg/m2

Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-05-31
Completion
2013-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751867 on ClinicalTrials.gov