This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate hematopoietic response of darbepoietin alfa and the quality of life assessment of increasement of hemoglobin.
Darbepoietin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with malignant lymphoma. Darbepoietin will be applied to R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy every 21days ± 2days with fixed 360㎍. It will be applied to chemotherapy until increment of hemoglobin 12.0g/dL. If the hemoglobin level exceeds 12.0g/dL, administration of darbepoietin will be temporarily stopped. And, the questionnaire of the quality of life will be conducted at the baseline, after 2th darbepoietin alfa administration, at study completion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
53
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
Hematopoietic response
Hemoglobin level after Darbepoietin alfa administration
Time frame: hemoglobin level of day 21 after Darbepoietin alfa administration
Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia
Time frame: at baseline, Day 21 after 2th darbepoietin alfa administration, Day 21 after last darbepoietin alfa administration
Adverse events as measured by CTCAE v3.0
Time frame: From the date of first drug administration to the date of the 30th days of last drug administration.
Proportion of patients requiring red blood cell transfusions
Time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
Mean time to response of hemoglobin
Time frame: From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration
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