Lymphoma Clinical Trial
Official title:
A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and
treat anemia in patients who are receiving chemotherapy. It is not yet known whether
darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with
that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for
cancer.
OBJECTIVES:
Primary
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with
non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and
type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12
weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed
at 1 and 3 weeks .
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this
study within 6 months.
;
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