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
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
- Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
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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