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NCT00619099 · ClinicalTrials.gov registry record · Phase 2
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
A Phase 2 study of Myelodysplastic Syndrome, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 4
- Study locations
NCT00619099: Completed Phase 2 study of Myelodysplastic Syndrome, sponsored by Eisai.
NCT00619099 is a Phase 2 study of Myelodysplastic Syndrome that has completed, run by Eisai. The registered enrollment target is 67 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (68% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619099, a Phase 2 study of Myelodysplastic Syndrome, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
Primary Outcome
Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement. Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.
Conditions Studied
Interventions
- DRUG decitabine
Study Locations (4)
Ohio
- Gabrail Cancer Center - Canton
Rhode Island
- Landmark Medical Center - Woonsocket
Tennessee
- Sarah Cannon Research - Nashville
Texas
- M. D. Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00619099 record still lists
NCT00619099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which decitabine is the first listed.
NCT00619099 reports a single indexed study location in Ohio, Rhode Island, Tennessee.
Frequently Asked Questions
What is clinical trial NCT00619099 about?
NCT00619099 is a clinical study titled "A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)". The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
What is the current status of trial NCT00619099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2008-05.
What conditions does trial NCT00619099 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00619099?
The interventions under investigation include: decitabine (DRUG).
Who is sponsoring clinical trial NCT00619099?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00619099 being conducted?
This trial has 4 study locations across Ohio, Rhode Island, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00619099's enrollment target sits among peer trials
67 52nd of 134 higher than 83 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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