A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy
Epoetin alfa is a medication that helps the body make more red blood cells.
Before treatment you will have a complete physical exam. You will have around 1 tablespoon
of blood drawn for blood tests (these tests are in addition to the routine blood tests you
will have as part of your standard of care). Women who are able to have children must have
a negative blood pregnancy test.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
Patients in the first group will be given epoetin alfa once a week at the time chemotherapy
is started. Patients in the other group will not receive epoetin alfa, but will undergo the
same laboratory exams and quality of life evaluations as the group of patients who were
given epoetin alfa.
Patients in both groups will receive transfusions if their hemoglobin drops below a certain
level or it the doctor feels it is necessary. These transfusions are considered to be
standard of care. You will be asked to keep a diary listing the dates of all transfusions
If you are assigned to receive epoetin alfa, you will be given epoetin alfa once a week
during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa
for up to 6 courses of chemotherapy (usually around 5 months, but may be longer). Epoetin
alfa will be given to you as an injection under the skin. Once a week, you will have around
1 tablespoon of blood drawn to check the level of hemoglobin in your blood. If your
hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily
stopped until your hemoglobin level decreases.
Patients in both groups will continue to receive chemotherapy during this study as
scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2
weeks for routine blood tests (as part of your standard of care for treatment of cancer).
If you agree to the optional procedures, you will continue receiving epoetin alfa even if
your hemoglobin levels show that you are not responding to epoetin alfa treatment. However,
if you do not choose to take part in the optional procedures and you are not responding to
epoetin alfa treatment, you will be taken off the study.
If you experience any intolerable side effects that are a result of epoetin alfa or your
disease gets worse, you will be taken off the study.
This is an investigational study. Epoetin alfa is FDA approved and commercially available.
Around 164 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean Number of RBC Units Transfused During Initial 5 Months of Treatment
Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.
5 weeks to 5 Months
Jorge Cortes, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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