Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Lenalidomide in Kaposi Disease Associated With HIV Infection (ANRS 154/LENAKAP)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
研究概览
简要总结
Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.
详细描述
Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.
The observation period is 48 weeks. The main criteria is evaluated at 24 weeks Inclusion period: 72 weeks from the setting-up meeting.Lenalidomide will be stopped in the case of progression and the patients will be considered as drop-out from the trial, but will be taken into account in the final analysis.
Two-steps procedure: 14 evaluable patients in the first step; if one response to treatment is observed, other patients are included up to 25 evaluable patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non childbearing (negative serum Human Chorionic Gonadotropin-hCG) non breastfeeding women who practice adequate birth control, maintained 4 weeks after stopping lenalidomide
- •Age over 18 years and below 75 years
- •Able and willing to give written informed consent
- •Serologic documentation of HIV infection by approved tests, undetectable HIV viral load (below 50 copies/mL) independently of CD4 cell counts
- •Biopsy proven symptomatic Kaposi sarcoma with at least 4 measurable cutaneous lesions
- •Treatment by cART for at least 12 months, without wash out the last 6 months with undetectable HIV-RNA (below 50 copies/mL)
- •History of treatment failure or relapse with 1 or more chemotherapy
- •Progressive disease with need to new specific therapy
- •Wash-out over 4 weeks if previous specific Kaposi sarcoma chemotherapy (8 weeks if Interferon -IFN therapy)
- •Karnofsky performance status over 70%
- •Social security (State Medical Assistance is not a social security scheme)
- •Agree to abstain from donating blood
- •Agree not to donate semen
- •Agree not to share study drug with another person
排除标准
- •Childbearing or breastfeeding (positive betaHCG serum)
- •Kaposi sarcoma with only visceral locations
- •Kaposi sarcoma with cardiac and/or bronchopulmonary localisations
- •2 viral loads over 50 copies/mL under Highly active antiretroviral therapy (HAART), during the last 6 months
- •Opportunistic infections, uncontrolled infections
- •Cardiac disease
- •Castleman disease or lymphoma
- •Other cancers or previous or current haematological malignancies
- •Polyneuritis, grade over 2
- •Association with neurotoxic drugs such as isoniazid, d4T
- •Neutrophil polynuclear count below 1000/mm3 or platelets below 75000/mm3
- •Life expectation under 2 months
- •Creatinine clearance below or equal 50 mL/min (Cockcroft-Gault formula)
- •Serum Glutamopyruvate Transferase (SGPT) or Serum Glutamooxaloacetate Transferase (SGOT) over or equal 3
- •Concomitant treatment with antineoplastic drugs
- •Known allergy or hypersensitivity to aspirin, to lenalidomide
- •Contraindication to anticoagulant drugs
- •Safeguard justice
研究组 & 干预措施
Lenalidomide
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
时间窗: Clinical benefit at week 24
For all patients clinical tumour evaluation : complete clinical examination, tumour scoring according to the Aids Clinical Trials Group (ACTG) and The Physician's Global Assessment (PGA) and laboratory assessment. Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants. Such patients will be treated under the physician's responsability.
次要结局
- To estimate the time to the response and the duration of the response(From Week 0 to Week 48)
- To evaluate the efficacy using ACTG criteria(From Week 0 to Week 48)
- To evaluate the survival and the survival with no progression(From Week 0 to Week 48)
- To describe the evolution of virologic and immunological parameters(From Week 0 to Week 48)
- To estimate the safety of lenalidomide(From Week 0 to Week 48)
- To evaluate the efficacy of treatment at 48 weeks(Week 48)