初发III/IV期及复发难治侵袭性NK/T细胞淋巴瘤的临床试验

洪飞 · 发表于 2011-6-28 10:25:21

View Original / Current protocol
Registration number	ChiCTR-TNC-10000782
Date of registration in ChiCTR	2010-5-4
Registration Status	Retrospective registration
Public title	吉西他滨、左旋门冬酰胺酶、异环磷酰胺、地塞米松及足叶乙甙（GLIDE）方案治疗初发III/IV期及复发难治侵袭性NK/T细胞淋巴瘤的临床试验
Scientific title	吉西他滨、左旋门冬酰胺酶、异环磷酰胺、地塞米松及足叶乙甙（GLIDE）方案治疗初发III/IV期及复发难治侵袭性NK/T细胞淋巴瘤的临床试验
Secondary ID
Ethics approval status
Objectives of study	评价GLIDE方案治疗初治的III/IV期和复发难治的侵袭性NK/T细胞淋巴瘤的有效性和安全性
Health condition(s) or problem(s) studied	侵袭性NK/T细胞淋巴瘤（结外鼻型NK/T细胞淋巴瘤，侵袭性NK/T细胞白血病）
Study design	Non-control study
Type of study	Interventional
Minimum age	12
Maximum age	无限制
Gender	男女均可
Inclusion criteria	1、经病理组织学及免疫组织化学确诊的I/II期鼻型NK/T淋巴瘤患者。2、ECOG评分0-2分，无化疗禁忌症。3、预计生存期3个月以上。4、患者自愿参加并签署知情同意书。
Exclusion criteria	1、妊娠妇女或正在哺乳期妇女；2、任何无法控制的临床问题（如严重的精神、神经、心血管、呼吸、活动性感染等系统疾病）；3、已知对任何研究用药过敏的患者；
Interventions	治疗组: 吉西他滨 800mg/m^2 D1,8，左旋门冬酰胺酶 6000mg/m^2 D8,10,12,14,16,18,20，异环磷酰胺1g/m^2 D1-3，地塞米松40mg D1-4,D9-12（肠道淋巴瘤第一疗程给与强的松100mg D1-5），足叶乙甙 100mg/m^2 D1-3。总疗程6-8疗程。
Target sample size	总数: 10 治疗组: 10
Primary outcomes	总生存期, 客观有效率, III-IV级毒性反应, 完全缓解率,
Secondary outcomes	无病生存时间, 1年及2年生存率,
Blinding	治疗组: 否
Collecting sample(s) from participants	Blood Urine
Fate of the samples	Destruction after use
Type of enrolment	Phase IV
Anticipated date of the first enrolment	2010-01
Anticipated date of the last enrolment	2012-12
Recruitment status	Recruiting
Study phase	Clinical pre-test
Countries of recruitment [Province(s) and city(s)]	中国四川省四川大学华西医院
Institution(s) or hospital(s)	四川大学华西医院
Organizer institution (leader institution)	四川大学华西医院血液科
Institution responsible for collecting data	四川大学华西医院血液科
Source(s) of Funding	自筹
Project number of funding source	HXXY-NK/T 1.0
Sponsor(s)	四川大学华西医院
Sponsor(s) address	中国成都市国学巷37号
Secondary sponsor(s)
Date of application for trial registration	2010-02-10
Contact person for public queries	季杰
Address of contact person	四川大学华西医院血液科
Phone No. of contact person	+86 13086660487
Postcode of contact person	610041
Fax No. of contact person
Email of contact person	seasonj@gmail.com
URL of contact person
Contact person for scientific queries	季杰
Address of the trial leader	四川大学华西医院血液科
Phone No. of the trial leader	+86 13086660487
Postcode of the trial leader	610041
Fax No. of the trial leader
Email of the trial leader	seasonj@gmail.com