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招募患者：普拉曲沙治疗复发或难治性外周T细胞淋巴瘤的有效性和安全性的临床研究

2015-09-09 MedSci MedSci原创

普拉曲沙淋巴瘤
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1.  试验药物简介 Pralatrexate注射剂（商品名Folotyn, 普拉曲沙）2009年被FDA批准用于单药治疗复发/难治性T细胞淋巴瘤。   2.  试验目的 确认普拉曲沙治疗中国人群中复发或难治性复发/难治性T细胞淋巴瘤的有效性和安全性。   3.  试验设计 试验分类： 药代动力学/药效动力学试验 试验分期： III

1.  试验药物简介
Pralatrexate注射剂（商品名Folotyn, 普拉曲沙）2009年被FDA批准用于单药治疗复发/难治性T细胞淋巴瘤。
 
2.  试验目的
确认普拉曲沙治疗中国人群中复发或难治性复发/难治性T细胞淋巴瘤的有效性和安全性。
 
3.  试验设计
试验分类： 药代动力学/药效动力学试验
试验分期： III期
设计类型： 单臂试验
随机化：  非随机化
盲法： 开放
试验范围： 国内试验
入组人数：   68
 
4.  入选标准
   1 根据世界卫生组织（WHO）疾病分类，受试者具有经组织学或细胞学确认的PTCL：外周T细胞淋巴瘤，非特指型（NOS）血管免疫细胞性T细胞淋巴瘤 ;间变性大细胞淋巴瘤，ALK阳性;间变性大细胞淋巴瘤，ALK阴性;结外NK/T细胞淋巴瘤，鼻型 ;肠病相关性T细胞淋巴瘤;肝脾T细胞淋巴瘤;皮下脂膜炎样T细胞淋巴瘤;成人T细胞淋巴瘤或白血病（人T细胞白血病病毒[HTLV]1阳性）侵袭性NK细胞白血病 转化的蕈状霉菌病
2 受试者必须在至少一次既往系统治疗后发生有证据的疾病进展（PD）
3 受试者接受过的试验性药物或生物制剂不可作为既往的唯一治疗。受试者必须在接受最后一次治疗后发生明确的PD。受试者应在初次诊断或复发时至少接受过一次活检，以确诊PTCL。受试者必须从既往治疗的毒性反应中恢复。
4 受试者应具有可在2个垂直方向明确测量的增大淋巴结或结外肿块病灶，病灶在研究入组前14天之内进行的计算机断层扫描检查显示最大直径大于1.5c
5 美国东部肿瘤协作组（ECOG）体能评分小于等于 2分
6 年龄大于等于18岁
7 预计的寿命预期大于等于3个月
8 合适的血液学、肝脏和肾脏功能，定义为： 绝对中性粒细胞计数（ANC）≥1000/uL（或1×109/L），血小板计数≥100,000/uL（或100×109/L）（筛选时以及在第1周期第1天之前3天之内）；总胆红素≤1.5mg/dL，天门冬氨酸氨基转移酶（AST）和丙氨酸氨基转移酶（ALT）≤2.5×正常上限（ULN）（如果肝脏有淋巴瘤侵犯证据，AST/ALT<5×ULN）；肌酐≤1.5mg/dL（或132.6μmol/L），或计算肌酐清除率≥50mL/min
9 具有生育潜力的女性必须同意从研究治疗开始起直到给予最后一剂普拉曲沙后至少30天期间采用医学上可接受的避孕措施，并且在研究治疗首日之前14天之内的血清妊娠检查结果必须为阴性。绝经至少1年（最后一次月经以来> 12个月）或接受过绝育术的受试者无需这项检查
10   未接受过绝育手术的男性必须同意从研究治疗开始起直到给予最后一剂普拉曲沙后至少90天期间采用医学上可接受的避孕措施
11   受试者签署书面知情同意（IC）
 
5.  排除标准
1 受试者诊断为:前体T细胞淋巴瘤或白血病;T细胞幼淋巴细胞白血病（T-PLL);T细胞大颗粒淋巴细胞白血病 ;蕈状霉菌病，除外转化的蕈状霉菌病;Sezary综合征;原发性皮肤CD30+T-细胞疾病：淋巴组织样丘疹病和原发皮肤间变性大细胞淋巴瘤
2 同时患有其他恶性肿瘤（不包括非黑色素瘤皮肤癌或宫颈原位癌）。如果有既往恶性肿瘤史，则患者无疾病时间需大于等于5年
3 充血性心力衰竭III/IV级（纽约心脏协会心力衰竭指南）
4 人免疫缺陷病毒（HIV）抗体阳性
5 患有脑转移或中枢神经系统（CNS）疾病或此类疾病史
6 未控制的活动性感染，潜在医学状况包括不稳定心脏疾病或其他会损害受试者接受方案治疗的严重疾病
7 进入研究前2周之内接受过重大手术
8 研究治疗之前4周（亚硝基脲或丝裂霉素C须 6周）之内接受过或者在研究进程期间计划接受任何常规化疗或放疗
9 研究治疗之前7天之内接受过皮质类固醇类，除非受试者在研究治疗之前以固定剂量至少1个月持续接受不超过强的松10mg/天或等效剂量的系统治疗，或者接受局部或吸入性或鼻内给药，并且未观察到有肿瘤的缩小
10 研究治疗之前4周之内使用过或者在研究进程期间计划使用任何试验药物、生物制剂或器械
11 在开始研究治疗前的100天之内接受过抗肿瘤抗体治疗
12 有异体造血干细胞移植史。或者受试者在研究治疗前100天之内有自体造血干细胞移植史
13既往接受过普拉曲沙治疗
14 患者怀孕或处于哺乳期

6. 研究者信息

序号

机构名称

主要研究者

国家

省（州）

城市

1

北京肿瘤医院

朱军

中国

北京

北京

2

北京大学第三医院

克晓燕

中国

北京

北京

3

中国人民解放军307医院

苏航

中国

北京

北京

4

天津肿瘤医院

张会来

中国

天津

天津

5

上海复旦大学附属肿瘤医院

洪小南

中国

上海

上海

6

上海长征医院

侯健

中国

上海

上海

7

江苏省肿瘤医院

冯继锋

中国

江苏

南京

8

浙江大学医学院附属第一医院

金洁

中国

浙江

杭州

9

浙江省肿瘤医院淋巴瘤中心

杨海燕

中国

浙江

杭州

10

中山大学肿瘤防治中心

黄慧强

中国

广东

广州

11

四川大学华西医院

谢莉萍

中国

四川

成都

12

福建医科大学附属协和医院

胡建达

中国

福建

福州

13

吉林大学第一医院

李薇

中国

长春

吉林

14

中国医学科学院肿瘤医院

石远凯

中国

北京

北京

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    2016-07-01 marlenexl

    #细胞淋巴瘤#

    0

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    2015-09-11 xlxchina

    #外周T细胞淋巴瘤#

    0

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    2015-09-11 aliceclz

    #T细胞淋巴瘤#

    0

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    2015-09-11 freve

    #难治性#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1702381, encodeId=d2891e0238102, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Fri Jul 01 01:15:00 CST 2016, time=2016-07-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1312202, encodeId=439113122024d, content=<a href='/topic/show?id=029d42e9060' target=_blank style='color:#2F92EE;'>#外周T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42790, encryptionId=029d42e9060, topicName=外周T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=570f404, createdName=xlxchina, createdTime=Fri Sep 11 13:15:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372612, encodeId=17e113e261231, content=<a href='/topic/show?id=7d2d1802820' target=_blank style='color:#2F92EE;'>#T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18028, encryptionId=7d2d1802820, topicName=T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfa6343, createdName=aliceclz, createdTime=Fri Sep 11 13:15:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528296, encodeId=495e152829620, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Fri Sep 11 13:15:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548486, encodeId=f6dd1548486d2, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Fri Sep 11 13:15:00 CST 2015, time=2015-09-11, status=1, ipAttribution=)]
    2015-09-11 ms1260584454294838

    #招募#

    0