EUCTR2011-002810-35-IT进行中（未招募）不适用
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2012年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients must have histologically confirmed classical Hodgkin lymphoma (HL).
- •-Patients must have failed an autologous stem cell transplant or be ineligible for high-dose therapy due to chemorefractory disease (as defined as <50% response to standard salvage chemotherapy), age or comorbidity.
- •-Patients must have at least one target PET-avid bidimensionally measurable lesion,
- •-Age >18 years
- •-Life expectancy of greater than 3 months
- •-ECOG performance status <2
- •-Patients must have adequate organ and marrow function as defined below:
- •-absolute neutrophil count >1,000/?L
- •-platelets >75,000/?L
- •-total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's); however dose reduction is recommended for Bendamustine. in patients with 30 – 70 % tumour involvement of the liver and moderately diminished liver function (serum bilirubin 1.2 – 3.0 mg/dl).
- •-AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal
- •-creatinine within normal institutional limits OR creatinine clearance >50 mL/min/1.73 m2
- •-Patients must have echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50%
- •-If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for ~ 5 years at the time of enrolment
- •-Patients must accept contraception measures until 4 weeks after the completion of chemotherapy, and up to 6 months for male patients.
- •-Women of child-bearing must have a medically supervised negative pregnancy test even if had been using effective contraception.
- •-Patients agree not to share study medication with another person and to return all unused study drug to the investigator
- •-Patients or their guardians must be capable to understand and must be willing to sign a written informed consent document
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •?Treatment with chemotherapy or external radiotherapy within 6 weeks, or monoclonal antibodies within 8 weeks or radio-immunoconiugates in the previous 12 weeks prior to entering the study
- •?Treatment with any other investigational agent
- •?Parenchymal brain or leptomeningeal HL involvement
- •?History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study
- •?Known HIV positivity or active infectious hepatitis, type A, B, or C
- •?Clinically significant cardiac disease (NYHA Class III or IV)
- •?Abnormal QTcF interval prolonged (> 459 msec)
- •- Known pregnancy or breastfeeding.
- •- Jaundice
- •?Yellow fever vaccination
- •?Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude safe administration of lenalidomide and bendamustine
- •?Corticoid treatment different from low dose prednisone or methylprednisone (up to 16 mg), used for B symptoms control.
- •?Controindications for receiving prophylaxis against deep vein thrombosis
- •?Thromboembolic disease grade 3-4 in the last 6 months
- •?More than one month between staging procedures and the start of the treatment
- •?Major surgical procedures less than 30 days before the start of treatment
研究者
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