Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

NCT00067808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2012-08-07

Study results available
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Summary

The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.

Conditions

Interventions

DRUG

Decitabine

10 mg/m\^2 by vein over 1 hour daily for 10 days

DRUG

Decitabine

20 mg/m2 by vein (IV) over 1 hour daily x 5 days

DRUG

Decitabine

20 mg/m2 subcutaneous (SQ) daily x 5 days

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hagop M Kantarjian, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT00067808 on ClinicalTrials.gov