NCT00003341已完成3 期
The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 18
研究概览
简要总结
RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best time for giving epoetin alfa during chemotherapy is not yet known.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are receiving chemotherapy.
详细描述
OBJECTIVES:
- Determine the hematologic response and transfusion requirements of patients with malignant lymphoma, chronic lymphocytic leukemia, or multiple myeloma with chemotherapy related moderate anemia treated with epoetin alfa.
- Determine the effect of moderate anemia on quality of life of these patients treated with this regimen.
- Correlate changes in quality of life with changes in anemia associated with treatment with epoetin alfa in these patients.
- Determine the effect of changing quality of life on health care resource utilization among these patients treated with epoetin alfa.
OUTLINE: This is a randomized, open label, multicenter study.
Patients are evaluated for anemia during their prescribed chemotherapy regimens at either 3 or 4 week intervals beginning week 3 or 4. Patients with hemoglobin levels of 10.0-12.0 g/dL are randomized to 1 of 2 treatment arms. Patients with hemoglobin levels greater than 12.0 g/dL are not randomized until their hemoglobin levels decrease to 12.0 g/dL or below.
- Arm I: Patients immediately receive epoetin alfa subcutaneously each week.
- Arm II: Patients are observed for 6-8 weeks and then hemoglobin levels are reevaluated. Patients whose hemoglobin levels decrease below 9.0 g/dL receive epoetin alfa subcutaneously each week. Patients whose hemoglobin levels are at least 9.0 g/dL are observed for another 3-4 weeks and then hemoglobin levels are reevaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia, or multiple myeloma
- •Low grade, intermediate grade, or high grade (diffuse large cell immunoblastic only) NHL OR
- •Histologically confirmed Hodgkin's disease with prior chemotherapy
- •Evaluable lesion
- •Must be scheduled for at least 1 myelosuppressive cytotoxic regimen (experimental chemotherapy regimens allowed) for at least 4-6 months
- •No anemia predominantly due to factors other than cancer or chemotherapy (i.e.,iron or folate deficiencies, hemolysis, or gastrointestinal bleeding) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Transferrin saturation at least 20%
- •Ferritin at least 50 ng/mL OR
- •Adequate iron stores in bone marrow
- •If transferrin saturation is less than 20% or ferritin is less than 50 ng/mL, investigator may utilize bone marrow evaluation results to determine whether iron stores are adequate
- •Hemoglobin at least 10.0 g/dL
- •Not specified
- •Not specified
- •Cardiovascular:
- •No uncontrolled hypertension
- •HIV negative
- •No active, unresolved infection
- •No hypersensitivity to mammalian cell derived products
- •Must be able to read and understand English at a 6th grade level consistent with comprehending the quality of life questionnaires
- •No other malignancy within past 5 years, except basal cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent epoetin alfa independent of protocol
- •No concurrent interferons and interleukins (occasional short term use may be permitted on a case by case basis)
- •No prior peripheral blood stem cell transplantation
- •Chemotherapy:
- •See Disease Characteristics
- •At least 2 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy
- •Not specified
- •At least 30 days since prior nonchemotherapy experimental agents
排除标准
- 未提供
研究者
研究点 (18)
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