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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

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

epoetin alfa

+ quality-of-life assessment

BiológicoProcedimiento
Quiénes están siendo reclutados

Trastornos de las Proteínas Sanguíneas+24

+ Enfermedades Cardiovasculares

+ Enfermedad Crónica

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Cuidados de Apoyo

Fase 3
Intervencional
Inicio del estudio: diciembre de 1997
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 3 de julio de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

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.

NCT00003341
Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 3 de julio de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 275 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Cuidados de Apoyo

Estos estudios exploran maneras de mejorar el confort y la calidad de vida diaria de las personas que viven con una condición. Pueden centrarse en aliviar síntomas, reducir efectos secundarios del tratamiento o apoyar el bienestar general.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

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

Trastornos de las Proteínas SanguíneasEnfermedades CardiovascularesEnfermedad CrónicaEnfermedades HematológicasEnfermedades hemáticas y linfáticasTrastornos HemorrágicosEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosLeucemia LinfocíticaEnfermedades LinfáticasTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoParaproteinemiasProcesos PatológicosCondiciones Patológicas, Signos y SíntomasEnfermedades VascularesLeucemia de células BAnemiaEnfermedad de HodgkinLeucemiaLinfomaLinfoma FolicularLinfoma no HodgkinMacroglobulinemia de WaldenströmMieloma MúltipleLeucemia linfocítica crónica de células B

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 Maps

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United States

Comprehensive Cancer Centers of the Desert

Palm Springs, United States
Completado18 Centros de Estudio