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Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

NCT01417767 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-09-09

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).

Conditions

Interventions

DRUG

CHG regimen

cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L.

DRUG

5-aza-deoxycytidine

Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2.

Sponsors & Collaborators

  • Xiao Li

    lead OTHER

Principal Investigators

  • Xiao Li, Doctor · Shanghai 6th People's Hospital

  • Lingyun Wu, Doctor · Shanghai 6th People's Hospital

  • Chunkang Chang, Doctor · Shanghai 6th People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01417767 on ClinicalTrials.gov