JPRN-jRCT2071210101进行中（未招募）2 期
Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial. - W-JHS NHL02
Akashi Koichi0 个研究点目标入组 20 人开始时间: 2021年12月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients who was histopathologically diagnosed as the following T cell lymphoma (TCL) (including extranodal NK/T-cell lymphoma)
- •/Peripheral T-cell lymphoma, not otherwise specified
- •/Angioimmunoblastic TCL
- •/ALK positive systemic anaplastic large cell lymphoma (ALCL)
- •/ALK negative ALCL
- •/Enteropathy-associated TCL
- •/Hepatosplenic TCL
- •/Subcutaneous panniculitis-like TCL
- •/Extranodal NK/T-cell lymphoma, nasal type
- •(2) Patients with skin lesions less than 10% of body surface area due to PTCL
- •(3) Patients with measurable legion.
- •Meet all following criteria of lesion in patients with peripheral T cell lymphoma.
- •Lymph node as lymphoma lesion or nodal mass of extranodal organ diagnosed by CT imaging.
- •Clearly measurable the size in 2 perpendicular dimensions with a CT section image
- •longer axis >= 1.5cm in CT section image, or if longer axis is <1.5cm, short axis is > 1.0cm.
- •(4) Patients with more than 2 regimens history by systemic anticancer drug (excluding adrenocortical hormone monotherapy, interferon and retinoid).
- •(5) Patients who have pre-treatment history by brentuximab vedotin or the drug is inappropriate about CD30-positive systemic anaplastic large cell lymphoma.
- •(6) Patients who were not provided PD or response (CR or PR) during with systemic antineoplastic treatment, or patients who recurred or aggravated again after systemic antineoplastic treatment.
- •(7) Patients who can provide tumor tissue sample for central pathological diagnosis.
- •(8) ECOG PS 0-1
- •(9) Patients with more than 3 months survival.
- •(10) Patients with sufficient renal function.
- •- Creatinine <=1.5x ULN or creatinine clearance >=40 mL/min (actual value or Cockcroft/Gault calculation)
- •(11) Patients with sufficient hepatic function.
- •- Total bilirubin <=1.5 x ULN
- •- Serum albumin >=3.0 g/dL (confirmed 2 weeks later after the administration of albumin preparation)
- •- AST and ALT <=3 x ULN
- •(12) Patients with sufficient bone marrow function. (confirmed 2 weeks later after the administration of G-CSF and blood transfusion)
- •- Neutrophil >=1.5 x 103/microL (1.5 x 109/L)
- •- Platelets >=7.5 x 104/microL
- •- Hemoglobin >=8.0g/dL
- •(13) Female childbearing patients (including patients without menstruation by medical reasons such as chemical menopause) agree to the double contraception at least seven months after informed consent and at least five months after nivolumab administration completion. In addition, patient who can agree to not nursing after informed consent and at least five months after nivolumab administration completion.
- •(14) Male patients who can agree to the double contraception at least seven months after nivolumab administration start and at least seven months after nivolumab administration completion.
- •(15) Patients providing written informed consent.
排除标准
- •(1) Patients with central nervous system lymphoma, intracerebral infiltration or bone marrow infiltration.
- •(2) Patients with autoimmune disease or history of chronic or recurrent auto immune disease.
- •(3) Patients with or history interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings. Patients with radiation pneumonia are eligible if stabilization by fibrosis is confirmed and its recurrence is not concerned.
- •(4) Patients with diverticulitis or symptomatic gastrointestinal ulcer disease to need treatment.
- •(5) Patients who received auto-HSCT within 90 days before initiation of nivolumab administration.
- •(6) Patients who received anticancer therapy such as chemotherapy and immunotherapy within 28 days before initiation of nivolumab administration.
- •(7) Patients who received mogamulizumab administration within 28 days before initiation of nivolumab administration.
- •(8) Patients who received other investigational new drugs administration within 28 days or within less than 5 times of elimination half-time (either long one) before initiation of nivolumab administration.
- •(9) Patients who received radiotherapy within 28 days before initiation of nivolumab administration (as for the local radiotherapy of symptom reduction purpose within 14 days). But chest radiotherapy shall be within 168 days.
- •(10) Patients who received systemic adrenal cortical hormone more than 10 mg/day doses by prednisolone conversion (except test or temporary use for the purpose of prophylaxis for allergic reaction) or immunosuppressant within 28 days before initiation of nivolumab administration.
- •(11) Patients who received all other investigational new drug (including the administration by clinical study, combination medicine of investigational new drug, new formulation medicine) within 28 days before initiation of nivolumab administration (in the case of antibody preparation within 90 days)
- •(12) Patients who received local or surface anesthesia, or operative treatment associated with general anesthesia within 14 days before initiation of nivolumab administration
- •(13) Patients with active double cancer. However, it is eligible if patients have basal cell cancer completely removed surgically, stage I spinocellular carcinoma, cancer in situ, intramucosal carcinoma or superficial bladder cancer or other cancers has which are not recognized recurrence more than 5years.
- •(14) Patients with anamnesis of transient cerebral ischemic attack, cerebrovascular attack, thrombosis or the thromboembolism (pulmonary artery embolism or deep vein thrombosis) within 180 days before enrollment to this clinical trial
- •(15) Patients with remained influence of side effect of pre-treatment or operative treatmen if principal investigator or sub investigator judge that they influence on the safety evaluation of nivolumab.
- •(16) Patients with the following uncontrollable or severe cardiovascular diseases.
- •a) Myocardial infarction within 180 days before enrollment to this clinical trial
- •b) Uncontrollable angina pectoris within 180 days before enrollment to this clinical trial
- •c) Congestive heart failure of the New York Heart Association (NYHA) classification grade III or IV
- •d) Uncontrollable hypertension in spite of appropriate treatment (eg. SBP>=150mmHg or DBP >= 90mmHg last more than 24 hours)
- •e) Arrhythmia to need treatment
- •(17) Patients with systemic infection need for treatment.
- •(18) Patients with either HIV antibody positive, HTLV-1 antibody positive, HBs antige
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