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NCT00003138 · ClinicalTrials.gov registry record · Phase 3
Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes
A Phase 3 study of Myelodysplastic Syndromes and Anemia, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT00003138: Completed Phase 3 study of Myelodysplastic Syndromes and Anemia, sponsored by Eastern Cooperative Oncology Group.
NCT00003138 is a Phase 3 study of Myelodysplastic Syndromes and Anemia that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 118 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003138, a Phase 3 study of Myelodysplastic Syndromes and Anemia, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the production of blood cells. It is not yet known whether erythropoietin with or without filgrastim is more effective than standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of erythropoietin with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome.
Primary Outcome
Whether a patient required transfusion or not at 4 months was recorded.
Conditions Studied
Interventions
- BIOLOGICAL Filgrastim
- BIOLOGICAL Erythropoietin
- PROCEDURE Transfusion
Study Locations (20)
Illinois
- Veterans Affairs Medical Center - Lakeside Chicago - Chicago
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
- CCOP - Illinois Oncology Research Association - Peoria
- CCOP - Carle Cancer Center - Urbana
Michigan
- CCOP - Michigan Cancer Research Consortium - Ann Arbor
- CCOP - Kalamazoo - Kalamazoo
- West Michigan Cancer Center - Kalamazoo
New Jersey
- Veterans Affairs Medical Center - East Orange - East Orange
- CCOP - Northern New Jersey - Hackensack
- Cancer Institute of New Jersey - New Brunswick
Iowa
- CCOP - Cedar Rapids Oncology Project - Cedar Rapids
- CCOP - Iowa Oncology Research Association - Des Moines
Colorado
- CCOP - Colorado Cancer Research Program, Incorporated - Denver
Louisiana
- MBCCOP - LSU Health Sciences Center - New Orleans
Massachusetts
- Tufts - New England Medical Center - Boston
Minnesota
- CCOP - Metro-Minnesota - Saint Louis Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 1998-03-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT00003138 record still lists
NCT00003138 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 3 interventions - of which Filgrastim is the first listed.
NCT00003138 names 20 study sites across 12 states, led by Illinois, Michigan, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00003138 about?
NCT00003138 is a clinical study titled "Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes". RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the production of blood cells. It is not yet known whether erythropoietin with or without filgrastim is more effective than standard blood transfusions in reducing the need for transfusions in patients who have ane...
What is the current status of trial NCT00003138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 1998-03-04. Estimated completion is 2014-05.
What conditions does trial NCT00003138 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Anemia.
What interventions are being tested in trial NCT00003138?
The interventions under investigation include: Filgrastim (BIOLOGICAL), Erythropoietin (BIOLOGICAL), Transfusion (PROCEDURE).
Who is sponsoring clinical trial NCT00003138?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003138 being conducted?
This trial has 20 study locations across Colorado, Illinois, Iowa, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT00003138's enrollment target sits among peer trials
118 48th of 173 higher than 126 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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