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
Epoetin alfa is a medication that helps the body make more red blood cells. Researchers want
to find out if it will be effective in reducing the need for blood transfusions in patients
who have AML or high-risk MDS and are receiving chemotherapy.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of 2 treatment groups. Participants in one group will be
given epoetin alfa along with blood transfusions, if the doctor thinks it is necessary.
Participants in the other group will not receive epoetin alfa. Instead they will only have
blood transfusions, which is the standard of care.
No matter what group you are in, you will receive transfusions if your hemoglobin (an
element of red blood cells that carries oxygen) drops below a certain level or if the doctor
thinks it is necessary. You will be asked to keep a diary listing the dates of all
transfusions you receive.
The study doctor will monitor your hemoglobin levels by checking your standard blood tests
done by your treating doctor. If your hemoglobin rises above a certain level, treatment
with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.
If you are assigned to receive epoetin alfa, you will receive it once a week by subcutaneous
(just under the skin) injection during your regularly scheduled chemotherapy. You will
receive treatment with epoetin alfa for up to 12 weeks.
If you experience any intolerable side effects or the disease gets worse, you will be taken
off this study.
Participants in both groups will continue to receive chemotherapy during this study as
regularly scheduled. During chemotherapy (as part of your standard of care), you will have
around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests.
This is an investigational study. Epoetin alfa is FDA approved and commercially available.
Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of transfusions (trn) required during the 12 weeks of treatment.
Jorge E. Cortes, M.D.
M.D. Anderson Cancer Center
United States: Institutional Review Board
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|