Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00382590 · ClinicalTrials.gov registry record · Phase 2
Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00382590: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00382590 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00382590, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age \> or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, or not placed on, studies of new agents. Secondary Objective: 1\. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts predicts response to either therapy or whether the ability of the 5 azacytidine + valproic acid combination to induce demethylation or acetylation parallels response.
Interventions
- DRUG Ara-C
- DRUG Valproic Acid (VPA)
- DRUG 5-Azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382590
The ClinicalTrials.gov registry entry for NCT00382590 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ara-C is the first listed.
NCT00382590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00382590 about?
NCT00382590 is a clinical study titled "Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients". Primary Objective: 1\. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age \> or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, ...
What is the current status of trial NCT00382590?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2005-08. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00382590?
The interventions under investigation include: Ara-C (DRUG), Valproic Acid (VPA) (DRUG), 5-Azacytidine (DRUG).
Who is sponsoring clinical trial NCT00382590?
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.