- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00968331
Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.
After this induction phase, the CR, PR and SD will continue Lenalidomide with the same schedule for other 8 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Bologna, Italia, 40138
- Institute Of Hematology "Seràgnoli"
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form.
- Be = 65 years of age at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with histological confirmation of DLBCL.
- Stage of disease at study entry may include stage II-III-IV according to Ann Arbor Classification
- Patients must have failed at least one prior treatments
- ECOG performance status of equal or less than 2 at study entry
- nLaboratory test results within these ranges:
- Absolute neutrophil count equal or major than 1.0 x 109/L
- Platelet count equal or major than 50 x 109/L
- Serum creatinine equal or less than 2.0 mg/dL
- Total bilirubin equal or less than 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) equal or less than 2 x ULN or equal or less 5 x ULN if hepatic metastases are present
- Hemoglobin equal or major than 8 g/dl
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study:
- for at least 28days before starting study drug
- while participating in the study
- for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom,diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
- Disease free of prior malignancies for equal or major 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: REVLIMID plus RITUXIMAB
Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles. |
Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.
Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To assess the antitumour activity of Lenalidomide plus Rituximab (REVLIRIT) as salvage treatment in elderly patients with relapsed or refractory DLBCL, in terms of Overall Response Rate (CR and PR)
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To assess the overall feasibility of the REVLIRIT regimen in terms of response To assess the duration of response, TTP and PFS, safety and tolerability of the REVLIRIT regimen in terms of AE and SAE frequency and severity
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Linfoma de células B
- Linfoma de células B grandes, difuso
- Efectos fisiológicos de las drogas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Factores inmunológicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Lenalidomida
- Rituximab
Otros números de identificación del estudio
- REVLIRIT01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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