Lymphoma Clinical Trial
Official title:
Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells.
Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet
known whether epoetin alfa or epoetin beta are more effective when given with or without
iron infusion in treating anemia in patients with cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare
how well they work with or without iron infusion in treating anemia in patients with cancer.
OBJECTIVES:
- Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without
parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.
OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy
comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
- Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low
molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV
over 10-30 minutes) on day 1.
In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13
g/dL, whichever comes first.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
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