EUCTR2017-001939-38-BE进行中（未招募）1 期
A prospective phase II study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with classical Hodgkin Lymphoma and coexisting medical conditions
YSARC0 个研究点目标入组 64 人开始时间: 2018年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
- •- Having a first diagnosis of classical Hodgkin lymphoma
- •- Age 61 years or older
- •- Unfit for polychemotherapy
- •- No previous treatment for Hodgkin lymphoma
- •- Ann Arbor stages: I-IV
- •- Baseline 18-FDG PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion
- •- A minimum life expectancy of 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •- Contra-indication to Nivolumab and /or vinblastin
- •- Subjects with active interstitial pneumonitis
- •- Subjects with active infectious disease
- •- Subjects with active, known or suspected autoimmune disease
- •- Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator’s decision)
- •- Any of the following abnormal laboratory values :
- •a. Calculated creatinine clearance < 30 mL/min (MDRD formula)
- •b. AST or ALT > 2.5 times the upper limit of normal (ULN)
- •c. Serum total bilirubin > 30µmol/L
- •d. Neutrophils<1G/L or Platelets<50G/L, (unless related to bone infiltration by lymphoma)
- •- Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :
- •a. Their disease was T1-T2a, N0, M0, with a Gleason score = 7, and a prostate specific antigen (PSA) = 10 ng/mL prior to initial therapy,
- •b. They had definitive curative therapy (ie, prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1,
- •c. At a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
- •- Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
- •- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •- Adult person under legal protection
- •- Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
- •- Documented infection with HIV
- •- Subjects with known active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known HCV RNA)
- •or subjects with known Active hepatitis B :
- •a. HBsAg positive
- •b. HBsAg negative, Ac anti-HBs positive and/or Ac anti-HBc positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for VHB DNA is negative)
- •- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.
研究者
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