A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
NCT00656448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2018-05-30
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.
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- Leukemia
Interventions
- DRUG
-
Procrit
40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
Sponsors & Collaborators
-
Centocor, Inc.
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Jorge E. Cortes, M.D. · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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