Phase 2
N=99
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00260065 ↗Enrolled (actual)
99
Serious AEs
65.7%
Results posted
Sep 2009
Primary outcome: Primary: Number of Participants Who Achieved Overall Response — 33 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Decitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Overall Response |
33 | — |
| SECONDARY Best Response and Overall Improvement |
51; 17; 16; 0; 18 | — |
Summary
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
Eligibility Criteria
Inclusion Criteria
- Must sign an Institutional Review Board (IRB) -approved informed consent form.
- Must be 18 years of age or older.
- Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
- If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
- If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Exclusion Criteria
- Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
- Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
- Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
- Must not have an active viral or bacterial infection.
Data sourced from ClinicalTrials.gov (NCT00260065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.