A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Acute Myelogenous Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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|
- Median Number of Participant Transfusions Required During 12 Weeks of Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Number of Participants With Complete Remission [ Time Frame: Baseline, weekly or until disease progression ] [ Designated as safety issue: No ]International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.
|Study Start Date:||March 2008|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Procrit Arm
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
No Intervention: No Procrit: Standard Arm
Participants do not receive Procrit before receiving blood transfusions.
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 the University of Texas (UT) MD Anderson Cancer Center.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656448
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jorge E. Cortes, M.D.||M.D. Anderson Cancer Center|