26. HTLV-1関連脊髄症 HTLV-1-associated myelopathy Clinical trials / Disease details
臨床試験数 : 29 / 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
| 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 | NCT05240612 (ClinicalTrials.gov) | May 2, 2022 | 13/2/2022 | A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM) | A Clinical Pharmacological Study of MT-3921 in Subjects With Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM) | HTLV-1-Associated Myelopathy (HAM) | Biological: MT-3921;Biological: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Recruiting | 20 Years | N/A | All | 15 | Phase 1 | Japan |
| 2 | NCT04799288 (ClinicalTrials.gov) | September 24, 2021 | 13/3/2021 | Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis | Phase I/II Study of Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis | HAM/TSP | Drug: Teriflunomide | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | United States |
| 3 | NCT04301076 (ClinicalTrials.gov) | June 15, 2020 | 6/3/2020 | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (EPOCH) for Adult T-Cell Leukemia-Lymphoma (ATL) | A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) | Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 Infection | Drug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine Sulfate | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
| 4 | NCT04004819 (ClinicalTrials.gov) | August 15, 2019 | 27/6/2019 | Rituximab for HTLV-1-associated Myelopathy | Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy | HTLV-1-associated Myelopathy | Drug: Rituximab | First Affiliated Hospital of Fujian Medical University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 2 | China |
| 5 | NCT02655471 (ClinicalTrials.gov) | July 1, 2017 | 16/11/2015 | Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection | Effect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot Study | HTLV-I Infections;Tropical Spastic Paraparesis | Drug: Raltegravir and Zidovudine | Universidad Peruana Cayetano Heredia | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 10 | Early Phase 1 | Peru |
| 6 | JPRN-JMA-IIA00324 | 29/06/2017 | 23/01/2018 | A Phase 3 Study of KW-0761 (Mogamulizumab) in Subjects with HTLV-1 Associated Myelopathy (HAM) | A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | HTLV-1 associated Myelopathy (HAM) | Intervention type:DRUG. Intervention1:KW-0761, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. Control intervention1:Placebo, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. | Kyowa Kirin Co., Ltd | NULL | Completed | >=20 YEARS | No Limit | BOTH | 52 | Phase 3 | Japan |
| 7 | JPRN-JapicCTI-173608 | 15/6/2017 | 06/06/2017 | A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | HTLV-1 associated Myelopathy (HAM) | Intervention name : KW-0761 INN of the intervention : Mogamulizumab Dosage And administration of the intervention : 0.3 mg/kg, IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | 20 | BOTH | 52 | Phase 3 | Japan | |
| 8 | NCT03191526 (ClinicalTrials.gov) | May 22, 2017 | 13/6/2017 | A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM) | A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM) | HTLV-1 Associated Myelopathy | Drug: KW-0761 0.3 mg/kg IV;Drug: Placebo (saline) | Kyowa Kirin Co., Ltd. | NULL | Terminated | 20 Years | N/A | All | 66 | Phase 3 | Japan |
| 9 | NCT03075553 (ClinicalTrials.gov) | May 17, 2017 | 1/3/2017 | Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma | Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL) | Blastic Plasmacytoid Dendritic Cell Neoplasm;Hepatosplenic T-Cell Lymphoma;HTLV-1 Infection;NK-Cell Lymphoma, Unclassifiable;Primary Systemic Anaplastic Large Cell Lymphoma, ALK-Negative;Recurrent Adult T-Cell Leukemia/Lymphoma;Recurrent Anaplastic Large Cell Lymphoma;Recurrent Angioimmunoblastic T-cell Lymphoma;Recurrent Enteropathy-Associated T-Cell Lymphoma;Recurrent Mycosis Fungoides;Refractory Adult T-Cell Leukemia/Lymphoma;Refractory Anaplastic Large Cell Lymphoma;Refractory Angioimmunoblastic T-cell Lymphoma;Refractory Enteropathy-Associated T-Cell Lymphoma;Refractory Mycosis Fungoides;Refractory Nasal Type Extranodal NK/T-Cell Lymphoma;Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified | Other: Laboratory Biomarker Analysis;Biological: Nivolumab | Mayo Clinic | National Cancer Institute (NCI) | Terminated | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 10 | NCT02631746 (ClinicalTrials.gov) | February 21, 2017 | 15/12/2015 | Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma | Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma | Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 Infection;Lymphomatous Adult T-Cell Leukemia/Lymphoma;Smoldering Adult T-Cell Leukemia/Lymphoma | Other: Laboratory Biomarker Analysis;Biological: Nivolumab;Other: Pharmacogenomic Study | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | United States |
| 11 | JPRN-UMIN000024086 | 2016/09/16 | 20/09/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor) | Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor) - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Drugs which possibly affect assessment in the study (e.g. methylprednisolone, prednisolone and other agents targeted to HAM) will be forbidden or limited until Week 48 and periodic evaluation and tests will be performed. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 5 | Phase 2 | Japan |
| 12 | JPRN-UMIN000024085 | 2016/09/16 | 20/09/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) | Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Prednisolone is orally administered at a maximum dose of 0.5mg/kg/day and then tapered to a maintenance dose of 5mg/day. Indistinguishable placebo is orally administered for 24 weeks, and then 5mg/day of prednisolone for the next 24 weeks. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 40 | Phase 2,3 | Japan |
| 13 | JPRN-UMIN000023798 | 2016/08/31 | 31/08/2016 | Phase IIb clinical trial of steroid therapy in patients with HAM | Phase IIb clinical trial of steroid therapy in patients with HAM - HAMLET-P | HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP) | Following to administrate Methylprednisolone 1000mg/day intravenously slowly for consecutive three days, Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease. Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease. | St. Marianna University School of Medicine Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 8 | Phase 2,3 | Japan |
| 14 | NCT02961712 (ClinicalTrials.gov) | July 2016 | 3/11/2016 | Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM) | Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy | HAM | Biological: NK cells;Biological: amniotic epithelial cells | The Second Affiliated Hospital of Fujian Medical University | Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | Recruiting | 18 Years | 75 Years | All | 15 | Phase 1 | China |
| 15 | JPRN-UMIN000016683 | 2015/03/13 | 05/03/2015 | Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study. | Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study. - Phase Ia/Ib study of Tax-targeting DC vaccine combined with anti-CCR4 Ab for ATL | Adult T-cell leukemia/lymphoma | Tax-targeting DC vaccine KW-0761 (Mogamulizumab) | Japan Agency for Medical Research and Development | National Hospital Organization Kyushu Cancer Center | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 9 | Phase 1 | Japan |
| 16 | JPRN-UMIN000015587 | 2014/11/04 | 03/11/2014 | Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients | Clinical trial with NaPPS for HTLV-1-associated myelopathy (HAM) patients - Clinical trial with NaPPS for HAM patients | HTLV-1-associated myelopathy (HAM) | period of intervention: 12 weeks 0-4 weeks: Normal saline solution by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 50 mg by subcutaneous injection period of intervention: 12 weeks 0-4 weeks: Normal saline solution by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 100 mg by subcutaneous injection period of intervention: 12 weeks 0-4 weeks: NaPPS 100mg/week by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 50 mg by subcutaneous injection period of intervention: 12 weeks 0-4 weeks: NaPPS 100mg/week by subcutaneous injection 4-12 weeks: NaPPS(Pentosan Polysulfate sodium) 100 100 mg by subcutaneous injection | ReqMed Company, Ltd | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 12 | Phase 2 | Japan |
| 17 | NCT01867320 (ClinicalTrials.gov) | September 5, 2013 | 21/5/2013 | Raltegravir for HAM/TSP | Pilot Study of Raltegravir, an Integrase Inhibitor, in Human T-Cell Lymphotrophic Virus-1(HTLV-1) Associated Myelopathy, Tropical Spastic Paraparesis (HAM/TSP) | HTLV-I Infection | Drug: Raltegravir | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | N/A | All | 19 | Early Phase 1 | United States |
| 18 | NCT01640002 (ClinicalTrials.gov) | May 2012 | 11/7/2012 | A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder | A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder | Overactive Bladder Associated With HTLV-1 | Drug: Propantheline Bromide;Drug: Placebo | Hospital Universitário Professor Edgard Santos | NULL | Recruiting | 18 Years | N/A | Both | 42 | Phase 1 | Brazil |
| 19 | NCT01620736 (ClinicalTrials.gov) | January 2012 | 25/1/2012 | Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load | Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load | Human T-cell Leukemia Virus Type 1 Infection | Drug: Raltegravir | Washington University School of Medicine | Merck Sharp & Dohme Corp. | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 20 | NCT01343355 (ClinicalTrials.gov) | January 2011 | 25/4/2011 | Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) | Open-Label, Exploratory Study of the Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) | HTLV-I-Associated Myelopathy | Drug: Tamibarotene | St. Marianna University School of Medicine | NULL | Active, not recruiting | 30 Years | 75 Years | Both | 15 | Phase 2/Phase 3 | Japan |
| 21 | NCT01274533 (ClinicalTrials.gov) | December 2010 | 10/1/2011 | Lenalidomide in HTLV-1 Adult T-Cell Leukemia | A Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/Lymphoma | Adult T Cell Leukemia/Lymphoma | Drug: Lenalidomide | Columbia University | Celgene Corporation | Completed | 18 Years | N/A | All | 4 | Phase 2 | United States |
| 22 | NCT01000285 (ClinicalTrials.gov) | September 2010 | 19/10/2009 | EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma | Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma | Leukemia-Lymphoma, Adult T-Cell | Drug: Bortezomib;Drug: Etoposide;Drug: Vincristine;Drug: Doxorubicin;Drug: Prednisone;Drug: Cyclophosphamide;Drug: Raltegravir | Washington University School of Medicine | NULL | Completed | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 23 | NCT01472263 (ClinicalTrials.gov) | September 2009 | 11/11/2011 | Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases | Effectiveness of Pentoxifylline in Attenuating Neurological Disease Associated With HTLV-1 and Negative Modulator of Pathological Immune Response. | HTLV-1;Tropical Spastic Paraparesis;Immune System Diseases;Physical Disability;Pentoxifylline | Drug: Pentoxifylline;Drug: Placebo | Hospital Universitário Professor Edgard Santos | NULL | Completed | 18 Years | 80 Years | Both | 48 | Phase 3 | Brazil |
| 24 | NCT00681980 (ClinicalTrials.gov) | February 2008 | 19/5/2008 | Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM) | Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil | Paraparesis Spastic Tropical | Drug: Valproic acid;Drug: costicosteroids;Drug: valproid acid plus corticosteroids | University of Sao Paulo | NULL | Completed | 18 Years | 70 Years | Both | 60 | Phase 3 | Brazil |
| 25 | NCT00773292 (ClinicalTrials.gov) | August 2006 | 15/10/2008 | Ciclosporin in HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) | The HAM Ciclosporin Study : an Observational Trial of Therapy in Early or Progressing HAM/TSP | HTLV I Associated Myelopathy | Drug: ciclosporin | Imperial College London | Medical Research Council;University Hospital Birmingham;Imperial College Healthcare NHS Trust | Completed | 16 Years | 75 Years | All | 7 | Phase 2/Phase 3 | United Kingdom |
| 26 | NCT00076843 (ClinicalTrials.gov) | February 3, 2004 | 12/7/2006 | Hu Mik-Beta-1 to Treat HTLV-1-Associated Myelopathy/Tropical Spastic Paraparesis | Phase I Study of HTLV-I-Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP) Using the Humanized MiK-Beta-1 Monoclonal Antibody Directed Toward the IL-2L-15R-Beta; Subunit (CD122) That Blocks IL-15 Action | HTLV-1 | Drug: Hu MiK-Beta-1 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | N/A | All | 9 | Phase 1 | United States |
| 27 | NCT00041327 (ClinicalTrials.gov) | October 2002 | 8/7/2002 | Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma | Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma | Lymphoma | Biological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudine | AIDS Malignancy Consortium | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | Both | 19 | Phase 2 | United States |
| 28 | NCT00272480 (ClinicalTrials.gov) | November 8, 1999 | 4/1/2006 | Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial | Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial | HTLV-I-associated Myelopathy | Drug: Zidovudine/lamivudine;Drug: Placebos | Imperial College London | NULL | Completed | 16 Years | 75 Years | All | 16 | Phase 2/Phase 3 | United Kingdom |
| 29 | NCT00001785 (ClinicalTrials.gov) | September 1998 | 3/11/1999 | Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM) | Combined Virological and Immunological Evaluation of Treatment of Patients With Early HTLV-1-Associated Myelopathy With Recombinant Human Interferon Beta-1a | HTLV-I Infection;Spinal Cord Disease;Tropical Spastic Paraparesis | Drug: Recombinant human interferon beta-1a | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 12 | Phase 2 | United States |