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
epoetin alfa
+ quality-of-life assessment
Trastornos de las Proteínas Sanguíneas+24
+ Enfermedades Cardiovasculares
+ Enfermedad Crónica
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de diciembre de 1997
Fecha en la que se inscribió al primer participante.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. Patients receive epoetin alfa treatment for up to 15 or 16 weeks. Qualify of life questionnaires are completed every 3 or 4 weeks until week 30 or 32. Patients are followed through week 36. PROJECTED ACCRUAL: A total of 275 patients (at least 130 per treatment arm) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 275 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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: Age: 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 Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension Other: 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 Surgery: Not specified Other: At least 30 days since prior nonchemotherapy experimental agents
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 18 ubicaciones
Alta Bates Comprehensive Cancer Center
Berkeley, United StatesAbrir Alta Bates Comprehensive Cancer Center en Google MapsUSC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesComprehensive Cancer Centers of the Desert
Palm Springs, United States