EUCTR2009-011020-65-ES
进行中（未招募）
不适用
n estudio en fase III sobre lenalidomida como mantenimiento tras citorreducción con gemcitabina o doxorrubicina liposómica +/- radioterapia en pacientes con linfoma cutáneo de células T avanzado no tratado previamente con quimioterapia intravenosa.(A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy.)
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 105 人2010年2月8日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- infoma cutáneo de células T: Micosis fungoide, estadio IIb a IV o síndrome de Sézary(Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome)
- 发起方
- European Organisation for Research and Treatment of Cancer
- 入组人数
- 105
- 状态
- 进行中（未招募）
- 最后更新
- 12年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •?Micosis fungoide, (estado IIB\-IV), o síndrome de Sézary.
- •La respuesta parcial o completa a una terapia citorreductora específica con gemcitabina o doxorrubicina liposómica no más de 6 semanas antes de la aleatorización. Es aceptable para los pacientes que entran en el estudio que han recibido radioterapia local para el control de los síntomas durante el período de terapia citorreductora.
- •Aptos para recibir quimioterapia (funcionamiento de los órganos adecuados, como se refleja en el aclaramiento de creatinina, pruebas de función hepática y hematopoyética índices).
- •Hoja informativa para el paciente
- •WHO Estado de rendimiento 0\-2\.
- •(\-Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome.
- •\-Partial or complete response to a specific debulking regimen consisting of either gemcitabine or liposomal doxorubicin no more than 6 weeks prior to randomization. It is acceptable for patients entering the study to have received local radiotherapy for symptom control during the debulking period.
- •\- Fit for chemotherapy (adequate organ function, as reflected by creatinine clearance, liver function tests and hematopoietic indices).
- •\- Patient informed consent.
- •\- WHO Performance status 0\-2\.)
排除标准
- •\- Enfermedad tratados previamente con quimioterapia intravenosa (gemcitabina o Caelyx se permite) utilizada en el régimen de terapia citorreductora.
- •\- Enfermedades no apropriada para la piel\-dirigida terapia (por local institution normas)
- •\- Contraindicaciones para el tratamiento con lenalidomida
- •(\- Disease previously treated by intravenous chemotherapy (gemcitabine or caelyx
- •are allowed) used in the debulking regimen.
- •\- Disease not appropriate for skin\-directed therapy (per local institution standards)
- •\- Contraindications to lenalidomide treatment)
结局指标
主要结局
未指定
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A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 14.1 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndrome System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2009-011020-65-GBEuropean Organisation for Research and Treatment of Cancer30