A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Hematopoietic response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diffuse large B cell lymphoma treated with R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone) chemotherapy
- •hemoglobin < 10.0 g/dL are shown at least 3 cycles after starting R-CHOP(Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone)
- •Currently receiving or planning to receive at least 4 times of darbepoetin
- •Age > 18 years
- •ECOG(Eastern Cooperative Oncology Group) performance status 0-2
- •Bilirubin < 2 times upper limit of normal
- •ALT(alanine aminotransferase) or AST(aspartate aminotransferase) < 5 times upper limit of normal
- •Creatinine < 2 times upper limit of normal
- •HIV negative
- •Ferritin > 20 mcg/L (i.e., not obviously iron deficient)
- •Can read Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia
- •Agree with informed consent
排除标准
- •Received radiation therapy at least 4 weeks before starting chemotherapy
- •serious pre-existing medical condition (e.g., cardiac failure [New York Heart Association Class III or IV, or left ventricular ejection fraction <50%], active peptic ulceration, uncontrolled diabetes mellitus, or acute diffuse infiltrative pulmonary disease)
- •uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
- •arrhythmia NCI CTCAE grade ≥ 2
- •History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months
- •active systemic infection requiring treatment, a known diagnosis of human HIV, or active hepatitis B (hepatitis B carriers were permitted)Malignancy was treated surgically or with local radiation therapy with curative intent and the patient has been disease free for > 3 years
- •known hypersensitivity to darbepoetin alfa
- •pregnant or nursing and Negative pregnancy test
- •previous diagnosis of another malignancy with radiographic or biochemical evidence of residual disease (except completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or an in-situ malignancy)
- •combined iron deficiency anemia
- •received erythropoietin at least one months before starting darbepoetin
- •considered autologous stem cell transplantation before finish 6 cycles of chemotherapy
- •untreated primary or metastatic CNS(central nervous system) malignancy
研究组 & 干预措施
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.
干预措施: Darbepoetin alfa (Drug)
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.
干预措施: R-CHOP (Drug)
结局指标
主要结局
Hematopoietic response
时间窗: hemoglobin level of day 21 after Darbepoietin alfa administration
Hemoglobin level after Darbepoietin alfa administration
次要结局
- Quality of life as measured by Functional Assessment of Cancer Therapy Scales for anemia(at baseline, Day 21 after 2th darbepoietin alfa administration, Day 21 after last darbepoietin alfa administration)
- Adverse events as measured by CTCAE v3.0(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(From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration)
- Mean time to response of hemoglobin(From the date of first darbepoietin alfa administration to day 21 after last darbepoietin alfa administration)
研究者
Ho Sup Lee
MD, PhD. associate professor, Division of hematology-Oncology
Kosin University Gospel Hospital