Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Colección de datos
Trastornos de las Proteínas Sanguíneas+12
+ Enfermedades Cardiovasculares
+ Enfermedades hemáticas y linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab. * Determine the time to treatment failure in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
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: * Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma) * Immunoglobulin (Ig) M, IgG, and IgA paraprotein * Measurable monoclonal paraprotein * Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab) * CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 500/mm\^3 * Platelet count ≥ 25,000/mm\^3 Hepatic * SGOT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN Renal * Creatinine ≤ 2.5 mg/dL (\> 2.5 mg/dL allowed if due to disease) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception during and for 6 months after study participation * No serious comorbid disease * No uncontrolled bacterial, fungal, or viral infection * No other active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior alemtuzumab * More than 3 months since other prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * More than 21 days since prior chemotherapy Endocrine therapy * More than 21 days since prior steroid therapy Radiotherapy * More than 21 days since prior radiotherapy Surgery * Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
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 15 ubicaciones
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesAbrir Jonsson Comprehensive Cancer Center at UCLA en Google MapsRocky Mountain Cancer Centers - Denver Midtown
Denver, United StatesRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesGreenebaum Cancer Center at University of Maryland Medical Center
Baltimore, United States