Erythropoietin for Management of Anemia Caused by Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02890602|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Darbepoetin alfa Drug: R-CHOP||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma|
|Study Start Date :||September 1, 2012|
|Actual Primary Completion Date :||November 28, 2017|
|Actual Study Completion Date :||December 7, 2017|
Experimental: Darbepoietin alfa
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
Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
Other Name: Nesp
R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
Other Name: Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone
- Hematopoietic response [ Time Frame: hemoglobin level of day 21 after Darbepoietin alfa administration ]Hemoglobin level 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 ]