JPRN-jRCT2033230370招募中3 期
Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel
Gina Bonaccorso0 个研究点目标入组 10 人开始时间: 2023年9月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Male or female adults >= 18 years of age
- •2) Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
- •3) Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
- •4) Deemed medically fit and stable to receive the product per the treating physician's evaluation
- •5) Repeat leukapheresis is not feasible per the treating physician's assessment
- •6) Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
- •7) In the Investigator's opinion, there is no satisfactory alternative therapy available to the patient
排除标准
- •1) History of hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
- •2) Uncontrolled active infection or inflammation per physician assessment
- •3) Primary central nervous system lymphoma
研究者
相似试验
进行中（未招募）
不适用
Estudio abierto de acceso expandido de tratamiento con Lapatinib y Capecitabina en sujetos con cáncer de mama localmente avanzado o metastático con sobreexpresión de ErbB2 - Expanded Access study of Lapatinib and Capecitabine in ErbB2 Positive Breast CancerCáncer de mama localmente avanzado o metastático con sobreexpresión de ErbB2MedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002080-93-ESGlaxo SmithKline Research and Development Limited4,000
进行中（未招募）
不适用
A phase II study for the treatment of patients with splenic marginal lymphoma with the combination of Cyclophosfamide, Vincristine, Liposomal Doxorubicin, Predinisone and RituximabTreatment of patients with newly diagnosed splenic marginal non Hodgkin lymphomaMedDRA version: 9.1Level: LLTClassification code 10062113Term: Splenic marginal zone lymphomaEUCTR2005-000693-45-ITG.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
进行中（未招募）
不适用
Estudio de extensión abierto para pacientes con enfermedad de Alzheimer que hayan completado uno de los dos estudios fase 3 doble ciego con Semagacestat (H6L-MC-LFAN o H6L-MC-LFBC). Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)Alzheimer's DiseaseEnfermedad de Alzheimer (EA)EUCTR2009-014424-29-ESEli Lilly and Company1,500
进行中（未招募）
1 期
Estudio abierto de extensión para los pacientes con lumbalgia crónica severa o dolor crónico severo debido a artrosis de rodilla que han completado alguno de los ensayos clínicos previos de fase IIIb de clorhidrato de tapentadol códigos KF5503/42, KF5503/43, KF5503/44 o KF5503/45.Artrosis de rodilla y lumbalgiaMedDRA version: 12.0Level: LLTClassification code 10024891Term: Low back painMedDRA version: 12.0Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2009-015527-82-ESGrünenthal Pharma S.A.128
招募中
2 期
The study of therapy to diarrhea symptoms by the bile acid sequestrantsJPRN-jRCTs031180044Misawa Noboru50