CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
Procritdrug
Likely dose
Procrit 40,000 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00656448
NCT00656448Phase 3Completed
CompareCT.gov

Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive Induction/Consolidation Chemotherapy

M.D. Anderson Cancer Center·interventional·Posted Apr 11, 2008·Updated May 30, 2018

In Brief

A Phase 3 clinical trial evaluating Procrit for Acute Myelogenous Leukemia and 2 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia
CountriesUnited States
CollaboratorsCentocor, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2008
Enrollment StartMar 1, 2008
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.2 years ago

Interventions

Procritdrug

40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.