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NCT00414310 · ClinicalTrials.gov registry record · Phase 2
Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
A Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 1
- Study location
NCT00414310: Completed Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00414310 is a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 153 participants, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00414310, a Phase 2 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.
Primary Outcome
Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with \< 5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/ L, and a platelet count \> 100 x 10\^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets \<100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Clinical Benefit: In MDS/CMML, as per Internatio
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Valproic Acid
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2006-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT00414310 record still lists
NCT00414310 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (26% lower).
The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.
NCT00414310 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00414310 about?
NCT00414310 is a clinical study titled "Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)". The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.
What is the current status of trial NCT00414310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2006-12. Estimated completion is 2015-05.
What conditions does trial NCT00414310 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00414310?
The interventions under investigation include: Decitabine (DRUG), Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT00414310?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00414310 being conducted?
This trial has 1 study location across 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 NCT00414310's enrollment target sits among peer trials
153 22nd of 134 higher than 113 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.
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