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NCT00398047 · ClinicalTrials.gov registry record · Phase 2

Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT00398047: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT00398047 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00398047, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white blood cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving azacitidine together with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes. PURPOSE: This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.

Primary Outcome

Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.

Interventions

  • DRUG Azacitadine and Hematopoietic Growth Factors

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2006-09
Est. Completion 2009-09
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

Why NCT00398047 stopped before completion

NCT00398047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Azacitadine and Hematopoietic Growth Factors is the first listed.

NCT00398047 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00398047 about?

NCT00398047 is a clinical study titled "Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes". RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white...

What is the current status of trial NCT00398047?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2006-09. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00398047?

The interventions under investigation include: Azacitadine and Hematopoietic Growth Factors (DRUG).

Who is sponsoring clinical trial NCT00398047?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00398047's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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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Source: ClinicalTrials.gov NCT00398047, the US trial registry maintained by the National Library of Medicine. NCT00398047 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.