16. クロウ・深瀬症候群 Crow-Fukase syndrome Clinical trials / Disease details

臨床試験数 : 13 / 薬物数 : 18 - (DrugBank : 8) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 81

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05263817 (ClinicalTrials.gov)	October 8, 2021	1/12/2021	A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis	A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis	POEMS Syndrome;Amyloidosis;Autoimmune Hemolytic Anemia;Vasculitis	Biological: CD19/BCMA CAR T-cells	Zhejiang University	Yake Biotechnology Ltd.	Recruiting	N/A	N/A	All	75	Early Phase 1	China
2	NCT04396496 (ClinicalTrials.gov)	September 22, 2020	15/5/2020	Treatment of POEMS Syndrome With Daratumumab	A Phase II Trial for the Treatment of POEMS Syndrome With Daratumumab	POEMS Syndrome	Drug: Daratumumab Injection	University of Arkansas	Janssen Scientific Affairs, LLC	Recruiting	18 Years	N/A	All	10	Phase 2	United States
3	NCT02921893 (ClinicalTrials.gov)	October 31, 2016	26/9/2016	Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome	Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome	Plasmacytoma;POEMS Syndrome	Drug: Dexamethasone;Drug: Ixazomib Citrate;Drug: Lenalidomide;Other: Questionnaire Administration	Mayo Clinic	National Cancer Institute (NCI)	Recruiting	18 Years	N/A	All	34	Phase 2	United States
4	JPRN-jRCTs031180421	15/08/2016	25/03/2019	LDCY-POEMS study	Phase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for POEMS syndrome	POEMS syndrome POEMS syndrome	Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)	Sakaida Emiko	NULL	Recruiting	>= 20age old	<= 70age old	Both	14	Phase 2	Japan
5	JPRN-UMIN000018660	2015/08/17	17/08/2015	Japanese POEMS syndrome with thalidmaide trial for compassionate use	Japanese POEMS syndrome with thalidmaide trial for compassionate use - Japanese POEMS syndrome with thalidmaide trial for compassionate use (JPOST15)	Crow-Fukase(POEMS) syndrome	FPF300 (thalidomide)100-300mg/day,at bedtime +Dexamethasone 20mg/day (day1-4) Duration:until the approval of thalidomide for POEMT syndrome	Chiba University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	20	Not selected	Japan
6	JPRN-UMIN000018385	2015/07/01	22/07/2015	Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF		POEMS syndrome	This study is composed of the following two steps of therapy. 1)PBSC mobilization using low dose cyclophosphamide and G-CSF 2)autologous peripheral stem cell transplantation after high dose chemotherapy	Chiba University HospitalDepartment of Hematology	NULL	Pending	20years-old	70years-old	Male and Female	14	Phase 2	Japan
7	NCT02193698 (ClinicalTrials.gov)	July 2014	16/7/2014	Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial	Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome	POEMS Syndrome	Drug: Lenalidomide +Dexamethasone	Chiba University	NULL	Completed	20 Years	N/A	Both	5	Phase 2	Japan
8	NCT01816620 (ClinicalTrials.gov)	March 2014	14/3/2013	Study to Evaluate Lenalidomide Plus Dexamethasone in Patients With Newly Diagnosed POEMS Syndrome	An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome	POEMS Syndrome	Drug: Lenalidomide , Dexamethasone	Peking Union Medical College Hospital	Celgene Corporation	Completed	18 Years	N/A	All	41	Phase 2	China
9	NCT01639898 (ClinicalTrials.gov)	July 2012	5/7/2012	POEMS Syndrome Treatment With Lenalidomide	Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.	POEMS Syndrome	Drug: Lenalidomide and dexamethasone	University Hospital, Limoges	Ministry of Health, France;Celgene Corporation	Completed	18 Years	N/A	All	51	Phase 2	France
10	JPRN-JMA-IIA00084	22/03/2012	19/03/2012	Japanese POEMS Syndrome with Thalidomide Trial	Japanese POEMS Syndrome with Thalidomide Trial	Crow-Fukase (POEMS) syndrome	Intervention type:DRUG. Intervention1:FPF 300 (thalidomide), Dose form:CAPSULE, Route of administration:ORAL.	J-POST Clinical Trial Office	Hokkaido University, Hokkaido Medical Center, Tohoku University, Chiba University, Saitama Medical University, Niigata University, Shinshu University, Nagoya University, Kinki University, Kobe City Medical Center General Hospital, Yamaguchi University, Kyushu University, Kagoshima University	Completed	>=20 YEARS	No Limit	BOTH	24	Phase 3	Japan
11	JPRN-JMA-IIA00046	13/09/2010	06/09/2010	Japanese POEMS Syndrome with Thalidomide Trial	Thalidomide Treatment for Crow-Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Extension Phase to Evaluate the Long-term Safety	Crow-Fukase (POEMS)syndrome	Intervention type:DRUG. Intervention1:FPF 300 (thalidomide), Dose form:CAPSULE, Route of administration:ORAL. Control intervention1:FPF300 (placebo), Dose form:CAPSULE, Route of administration:ORAL.	J-POST Clinical Trial Office	Hokkaido University, Hokkaido Medical Center, Tohoku University, Chiba University, Saitama Medical University, Niigata University, Shinshu University, Nagoya University, Kinki University, Kobe City Medical Center General Hospital, Yamaguchi University, Kyushu University, Kagoshima University	Completed	>=20 YEARS	No Limit	BOTH	24	Phase 2-3	Japan
12	EUCTR2008-003202-33-IT (EUCTR)	15/09/2009	17/11/2009	Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002	Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002	POEMS SYNDROME MedDRA version: 9.1;Level: SOC;Classification code 10029205	Trade Name: REVLIMID *21CPS 25MG INN or Proposed INN: Lenalidomide	ISTITUTO CLINICO HUMANITAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
13	NCT00971685 (ClinicalTrials.gov)	July 2009	3/9/2009	The Treatment of Lenalidomide in Patients With POEMS Syndrome	Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome	POEMS Syndrome	Drug: Lenalidomide and dexamethasone	Istituto Clinico Humanitas	NULL	Recruiting	18 Years	N/A	Both	16	Phase 2	Italy

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