肿瘤细胞治疗研究
英文原题：Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
这是一项 II 期注册临床试验，评估细胞治疗用于淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 83 例。试验地点：美国 · 迈阿密、芝加哥、波士顿、巴斯金里奇（共 10 个中心）。登记号：NCT02974647。
不限性别 · ≥ 18 Years
纳入标准： * 在入组机构经病理学确诊的T细胞或NK细胞淋巴瘤。对于CTCL，IB期或更晚期的患者符合入组条件。 * 至少接受过1次系统治疗后复发或难治的疾病，但T-PLL、LGL或伴有JAK2融合的T细胞淋巴增殖性疾病除外。 * 未接受过治疗的患者经与P.I.讨论后可允许入组。 * 年龄 ≥ 18 * ECOG ≤ 2 * 存在可测量病灶，定义为： * 系统性淋巴瘤采用Lugano分类或 * 血液或骨髓中可通过流式细胞术或形态学定量的异常和/或恶性淋巴细胞或 * CTCL患者mSWAT > 0或Sezary细胞计数 ≥ 1000 cells/μL * 既往针对T细胞淋巴瘤的系统性抗肿瘤治疗必须在治疗前至少2周停用。 * 允许使用旨在控制淋巴瘤相关症状的糖皮质激素，但须在ruxolitiib开始使用时已减量至20mg或以下 * 允许CTCL患者使用外用类固醇 * 既往恶性肿瘤的辅助治疗和维持治疗相关指南见第6.2节受试者排除标准 * 患者必须满足以下实验室检查标准： * ANC ≥ 1.0/mm^3 或 ANC >/= 0.5/mm^3（如患者因淋巴瘤导致基线中性粒细胞减少），血小板 ≥ 100 x 10^9/L 或 ≥ 50 x 10^9/L（如与淋巴瘤相关），Hgb ≥ 8g/dL * LGL 或 T-PLL 患者无需满足最低 ANC 或血红蛋白值即可入组 * 总胆红素 ≤ 1.5 x 正常值上限（ULN），或；如有记录显示淋巴瘤肝脏受累则 ≤ 3 x ULN，或有 Gilbert 综合征病史则 ≤ 5 x ULN；AST 和 ALT ≤ 3 x ULN；如因淋巴瘤受累则 ≤ 5 x ULN * 肌酐清除率 ≥ 30 mL/min；只要基线血小板 ≥ 150 x 10^9/L，肌酐清除率为 15-29 mL/min 也可接受 * 乙肝核心抗体或表面抗原阳性的患者，乙肝 PCR 必须为阴性，且需使用恩替卡韦或同等药物进行预防性治疗。 * HIV 感染者可以入组，前提是正在接受抗逆转录病毒治疗且无活动性感染。 排除标准： * 任何会妨碍受试者签署知情同意书的严重疾病、实验室检查异常或精神疾病。 * 未控制的合并疾病，包括但不限于：持续或活动性感染、未控制的糖尿病、有临床意义的肺炎、有症状的充血性心力衰竭、不稳定型心绞痛、心律失常，或会限制对研究要求依从性的精神疾病/社会状况。 * ECOG 体能状态 >2 * 既往接受过 ruxolitinib 治疗 * 正在接受针对其他原发恶性肿瘤的全身治疗（T细胞淋巴瘤除外） * 患有一种以上淋巴瘤的患者，经与MSK主要研究者讨论后可入组 * 为降低其他恶性肿瘤（T细胞淋巴瘤除外）复发风险而进行的辅助或维持治疗，经与MSK主要研究者讨论后是允许的 * 有生育能力的女性† 血清ß人绒毛膜促性腺激素（ß-HCG）妊娠试验必须为阴性。 * 有生育能力的女性是指性成熟女性，其：未接受过子宫切除术或双侧卵巢切除术；或尚未自然绝经至少连续24个月（即在前连续24个月内的任何时间有过月经）。
Inclusion Criteria: * Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible. * Relapse or refractory disease after at least 1 systemic therapy except for T-PLL, LGL, or T-cell Lymphoproliferative diseases with JAK2 fusion. * Untreated patients may be allowed after discussion with P.I. * Age ≥ 18 * ECOG ≤ 2 * Measurable disease defined by: * Lugano Classification for systemic lymphoma or * Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or * mSWAT \> 0 or Sezary count ≥ 1000 cells/μL for CTCL * Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 2 weeks prior to treatment. * Glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20mg or less by the time of ruxolitiib initiation * Topical steroids for CTCL are permitted * See section 6.2 Subject Exclusion Criteria for guideline regarding adjuvant and maintenance therapy for prior malignancy * Patients must meet the following lab criteria: * ANC ≥ 1.0/mm\^3 or ANC \>/= 0.5/mm\^3 (if patient has baseline neutropenia due to lymphoma), platelets ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L (if related to lymphoma), Hgb ≥ 8g/dL * Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin value for eligibility * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or; ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; AST and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement * Creatinine clearance ≥ 30 mL/min; creatinine clearance of 15-29 mL/min will be allowed as long as baseline platelets are ≥ 150 x 10\^9/L * For patients with positive hepatitis B core antibody or surface antigen, hepatitis B PCR must be negative and prophylaxis with entecavir or equivalent is required. * Patients with HIV are allowed provided that they are on anti-retroviral treatment with no active infections. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * ECOG performance status \>2 * Prior therapy with ruxolitinib * Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma) * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal Investigator * Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test. * A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：disease control rate · defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold. · 2 years
患者将接受ruxolitinib 20mg BID口服治疗，以28天为一个周期。ruxolitinib应每12小时口服一次，每天服药时间大致相同（±2小时）。治疗可持续进行，直至疾病进展、出现不可耐受的毒性、主治医生建议终止治疗或研究终止。
患者将接受ruxolitinib 20mg BID口服治疗，以28天为一个周期。ruxolitinib应每12小时口服一次，每天服药时间大致相同（±2小时）。治疗可持续进行，直至疾病进展、出现不可耐受的毒性、主治医生建议终止治疗或研究终止。
患者将接受ruxolitinib 20mg BID口服治疗，以28天为一个周期。ruxolitinib应每12小时口服一次，每天服药时间大致相同（±2小时）。治疗可持续进行，直至疾病进展、出现不可耐受的毒性、主治医生建议终止治疗或研究终止。
患者将接受ruxolitinib 20mg BID口服治疗，以28天为一个周期。治疗可持续进行，直至疾病进展、出现不可耐受的毒性、主治医生建议终止治疗或研究终止。
本研究的目的是检验名为 ruxolitinib 的研究药物可能产生的任何有益和不良作用。Ruxolitinib 通过阻断一种称为 JAK 的蛋白质发挥作用。JAK 与另一种称为 STAT 的蛋白质协同工作，对许多 T 或 NK 细胞淋巴瘤的存活非常重要。通过阻断 JAK，ruxolitinib 可能使 T 或 NK 细胞淋巴瘤缩小。
The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.
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