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NCT01165996 · ClinicalTrials.gov registry record · Phase 1
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01165996: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT01165996 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165996, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.
Primary Outcome
Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease ca
Interventions
- GENETIC microarray analysis
- DRUG decitabine
- OTHER flow cytometry
- OTHER DNA methylation analysis
- OTHER cytogenetic analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01165996 record still lists
NCT01165996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which microarray analysis is the first listed.
NCT01165996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01165996 about?
NCT01165996 is a clinical study titled "Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome". RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.
What is the current status of trial NCT01165996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01165996?
The interventions under investigation include: microarray analysis (GENETIC), decitabine (DRUG), flow cytometry (OTHER), DNA methylation analysis (OTHER), cytogenetic analysis (OTHER).
Who is sponsoring clinical trial NCT01165996?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01165996's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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