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NCT00384956 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes

A Phase 2 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target
1
Study location

NCT00384956: Completed Phase 2 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.

NCT00384956 is a Phase 2 study of Myelodysplastic Syndromes that has completed, run by Washington University School of Medicine. The registered enrollment target is 25 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00384956, a Phase 2 study of Myelodysplastic Syndromes, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.

Primary Outcome

Defined according to the modified International Working Group (IWG) (2006) response criteria for myelodysplasia: CR=bone marrow with \<5% myeloblasts and 0% peripheral blasts, hemoglobin ≥11g/dL, platelets ≥ 100 x 10\^9/L, and neutrophils ≥1.0 x 10\^9/L. Residual dysplasia was allowed. PR= All of the CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥50% over pretreatment but still \>5%.

Conditions Studied

Interventions

  • DRUG Azacitidine

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2006-08
Est. Completion 2010-03
Phase Phase 2

What the finished NCT00384956 record still lists

NCT00384956 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 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Azacitidine is the first listed.

NCT00384956 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT00384956 about?

NCT00384956 is a clinical study titled "A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes". The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.

What is the current status of trial NCT00384956?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2006-08. Estimated completion is 2010-03.

What conditions does trial NCT00384956 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes.

What interventions are being tested in trial NCT00384956?

The interventions under investigation include: Azacitidine (DRUG).

Who is sponsoring clinical trial NCT00384956?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00384956 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Myelodysplastic Syndromes

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 NCT00384956's enrollment target sits among peer trials

25 129th of 173 higher than 43 of 173 other Myelodysplastic Syndromes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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Source: ClinicalTrials.gov NCT00384956, the US trial registry maintained by the National Library of Medicine. NCT00384956 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.