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NCT00656617 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT00656617: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00656617 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656617, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS. Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.
Primary Outcome
Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2008-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT00656617 record still lists
NCT00656617 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT00656617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656617 about?
NCT00656617 is a clinical study titled "Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)". The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS. Once the highest safe dose is found, researchers will then try to learn if this combination treatment can he...
What is the current status of trial NCT00656617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2008-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00656617?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00656617?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656617's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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