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NCT00656448 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT00656448: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00656448 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656448, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about the remission rates (rates of recovery) in patients with cancer who have received treatment with epoetin alfa. The safety and effectiveness of this therapy will also be studied.
Primary Outcome
The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.
Interventions
- DRUG Procrit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00656448 record still lists
NCT00656448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Procrit is the first listed.
NCT00656448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656448 about?
NCT00656448 is a clinical study titled "A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS". The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about ...
What is the current status of trial NCT00656448?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2008-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00656448?
The interventions under investigation include: Procrit (DRUG).
Who is sponsoring clinical trial NCT00656448?
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
How this trial's enrollment target compares
Where NCT00656448's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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