51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04380831 (ClinicalTrials.gov) | February 24, 2022 | 30/4/2020 | TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body Irradiation | City of Hope Medical Center | National Cancer Institute (NCI) | Recruiting | 18 Years | 65 Years | All | 15 | Early Phase 1 | United States |
| 2 | EUCTR2019-004718-32-NL (EUCTR) | 09/10/2020 | 09/10/2020 | Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants? | Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial | Diffuse cutaneous systemic sclerosis according to the ACR/EULAR criteria;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Mycophenolate mofetil | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 3 | NCT01413100 (ClinicalTrials.gov) | September 15, 2011 | 8/8/2011 | Scleroderma Treatment With Autologous Transplant (STAT) Study | A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis | Systemic Scleroderma | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Active, not recruiting | N/A | 70 Years | All | 21 | Phase 2 | United States;Canada |
| 4 | JPRN-UMIN000031940 | 2010/09/07 | 28/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis | Systemic sclerosis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 5 | NCT01047072 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 6 | EUCTR2006-004598-83-GB (EUCTR) | 22/10/2008 | 24/10/2008 | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | Severe systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Neupogen Product Name: Filgrastim INN or Proposed INN: FILGRASTIM Trade Name: Thymoglobuline Product Name: Thymoglobuline Product Code: rbATG INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS Trade Name: Solu-Medrone Product Name: Methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA | EBMT (European group for Blood and Marrow Transplantation) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 7 | NCT00622895 (ClinicalTrials.gov) | September 1, 2006 | 22/2/2008 | Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma;Severe Systemic Sclerosis | Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy | Fred Hutchinson Cancer Research Center | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | N/A | 70 Years | All | 3 | Phase 1/Phase 2 | United States |
| 8 | NCT00282425 (ClinicalTrials.gov) | May 2005 | 24/1/2006 | Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Scleroderma | Biological: Hematopoietic stem cell transplantation | Richard Burt, MD | NULL | Terminated | 18 Years | 55 Years | Both | 8 | Phase 1 | United States |