A Phase 2 interventional study of Darbepoetin alfa and R-CHOP in Diffuse Large B-cell Lymphoma, sponsored by Kosin University Gospel Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Kosin University Gospel Hospital · Phase 2, Interventional, and Supportive care
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 53 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Hemoglobin level will be checked at every cycle's day 0 or 1(1cycle is 21days) after starting Darbepoietin alfa. It will be applied to chemotherapy until increment of hemoglobin 12.0 g/dL.
Drug: Darbepoetin alfa · Drug: R-CHOP
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
Also known as: Nesp
R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
Also known as: Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone
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
No study locations are listed for this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Kosin University Gospel Hospital