26. HTLV-1-associated myelopathy
26 clinical trials,   46 drugs   (DrugBank: 27 drugs),   37 drug target genes,   123 drug target pathways

Searched query = "HTLV-1-associated myelopathy", "Tropical spastic paraparesis", "HTLV-1", "HTLV-I-associated myelopathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
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1NCT04301076
(ClinicalTrials.gov)
June 15, 20206/3/2020Testing 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 InfectionDrug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll30Phase 1United States
2NCT02655471
(ClinicalTrials.gov)
July 1, 201716/11/2015Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 InfectionEffect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot StudyHTLV-I Infections;Tropical Spastic ParaparesisDrug: Raltegravir and ZidovudineUniversidad Peruana Cayetano HerediaMerck Sharp & Dohme Corp.Completed18 YearsN/AAll10Early Phase 1Peru
3JPRN-JMA-IIA00324
29/06/201723/01/2018A 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., LtdNULLCompleted>=20 YEARSNo LimitBOTH52Phase 3Japan
4JPRN-JapicCTI-173608
01/6/201706/06/2017A 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
Kyowa Hakko Kirin Co., Ltd.NULLcomplete20BOTH52Phase 3NULL
5NCT03191526
(ClinicalTrials.gov)
May 22, 201713/6/2017A 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 MyelopathyDrug: KW-0761 0.3 mg/kg IV;Drug: Placebo (saline)Kyowa Kirin Co., Ltd.NULLActive, not recruiting20 YearsN/AAll66Phase 3Japan
No.TrialIDDate_
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6NCT03075553
(ClinicalTrials.gov)
May 17, 20171/3/2017Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell LymphomaPhase 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 SpecifiedOther: Laboratory Biomarker Analysis;Biological: NivolumabMayo ClinicNational Cancer Institute (NCI)Terminated18 YearsN/AAll12Phase 2United States
7NCT02631746
(ClinicalTrials.gov)
February 21, 201715/12/2015Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/LymphomaPhase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/LymphomaAcute 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/LymphomaOther: Laboratory Biomarker Analysis;Biological: Nivolumab;Other: Pharmacogenomic StudyNational Cancer Institute (NCI)NULLCompleted18 YearsN/AAll3Phase 2United States
8JPRN-UMIN000024085
2016/09/1620/09/2016Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) 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 HospitalNULLRecruiting18years-oldNot applicableMale and Female40Phase 2;Phase 3Japan
9JPRN-UMIN000024086
2016/09/1620/09/2016Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor) 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 HospitalNULLRecruiting18years-oldNot applicableMale and Female5Phase 2bJapan
10JPRN-UMIN000023798
2016/08/3131/08/2016Phase IIb clinical trial of steroid therapy in patients with HAM 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 HospitalNULLRecruiting18years-oldNot applicableMale and Female8Phase 2;Phase 3Japan
No.TrialIDDate_
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11NCT02961712
(ClinicalTrials.gov)
July 20163/11/2016Immunotherapy 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 MyelopathyHAMBiological: NK cells;Biological: amniotic epithelial cellsThe Second Affiliated Hospital of Fujian Medical UniversityShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruiting18 Years75 YearsAll15Phase 1China
12JPRN-UMIN000016683
2015/03/1305/03/2015Novel 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. Adult T-cell leukemia/lymphomaTax-targeting DC vaccine
KW-0761 (Mogamulizumab)
Japan Agency for Medical Research and DevelopmentNational Hospital Organization Kyushu Cancer CenterComplete: follow-up continuing20years-old75years-oldMale and Female9Phase 1Japan
13JPRN-UMIN000015587
2014/11/0403/11/2014Clinical trial with NaPPS for HTLV-1-associated myelopathy (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, LtdNULLComplete: follow-up complete20years-oldNot applicableMale and Female12Phase 2Japan
14NCT01867320
(ClinicalTrials.gov)
September 5, 201321/5/2013Raltegravir for HAM/TSPPilot Study of Raltegravir, an Integrase Inhibitor, in Human T-Cell Lymphotrophic Virus-1(HTLV-1) Associated Myelopathy, Tropical Spastic Paraparesis (HAM/TSP)HTLV-I InfectionDrug: RaltegravirNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 YearsN/AAll19Early Phase 1United States
15NCT01640002
(ClinicalTrials.gov)
May 201211/7/2012A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive BladderA Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive BladderOveractive Bladder Associated With HTLV-1Drug: Propantheline Bromide;Drug: PlaceboHospital Universitário Professor Edgard SantosNULLRecruiting18 YearsN/ABoth42Phase 1Brazil
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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16NCT01620736
(ClinicalTrials.gov)
January 201225/1/2012Trial to Assess Effect of Raltegravir on HTLV-1 Proviral LoadPhase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral LoadHuman T-cell Leukemia Virus Type 1 InfectionDrug: RaltegravirWashington University School of MedicineMerck Sharp & Dohme Corp.Withdrawn18 YearsN/AAll0Phase 2United States
17NCT01343355
(ClinicalTrials.gov)
January 201125/4/2011Efficacy 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 MyelopathyDrug: TamibaroteneSt. Marianna University School of MedicineNULLActive, not recruiting30 Years75 YearsBoth15Phase 2;Phase 3Japan
18NCT01274533
(ClinicalTrials.gov)
December 201010/1/2011Lenalidomide in HTLV-1 Adult T-Cell LeukemiaA Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/LymphomaAdult T Cell Leukemia/LymphomaDrug: LenalidomideColumbia UniversityCelgene CorporationCompleted18 YearsN/AAll4Phase 2United States
19NCT01000285
(ClinicalTrials.gov)
September 201019/10/2009EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia LymphomaPhase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia LymphomaLeukemia-Lymphoma, Adult T-CellDrug: Bortezomib;Drug: Etoposide;Drug: Vincristine;Drug: Doxorubicin;Drug: Prednisone;Drug: Cyclophosphamide;Drug: RaltegravirWashington University School of MedicineNULLCompleted18 YearsN/AAll18Phase 1;Phase 2United States
20NCT01472263
(ClinicalTrials.gov)
September 200911/11/2011Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) DiseasesEffectiveness 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;PentoxifyllineDrug: Pentoxifylline;Drug: PlaceboHospital Universitário Professor Edgard SantosNULLCompleted18 Years80 YearsBoth48Phase 3Brazil
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
21NCT00681980
(ClinicalTrials.gov)
February 200819/5/2008Use 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, BrazilParaparesis Spastic TropicalDrug: Valproic acid;Drug: costicosteroids;Drug: valproid acid plus corticosteroidsUniversity of Sao PauloNULLCompleted18 Years70 YearsBoth60Phase 3Brazil
22NCT00773292
(ClinicalTrials.gov)
August 200615/10/2008Ciclosporin in HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)The HAM Ciclosporin Study : an Observational Trial of Therapy in Early or Progressing HAM/TSPHTLV I Associated MyelopathyDrug: ciclosporinImperial College LondonMedical Research Council;Selly Oak Hospital, Birmingham, UK;St Mary Hospital, Imperial College Healthcare NHS Trust, London, UKCompleted16 Years75 YearsBoth7Phase 2;Phase 3United Kingdom
23NCT00076843
(ClinicalTrials.gov)
February 3, 200412/7/2006Hu Mik-Beta-1 to Treat HTLV-1-Associated Myelopathy/Tropical Spastic ParaparesisPhase 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 ActionHTLV-1Drug: Hu MiK-Beta-1National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 YearsN/AAll9Phase 1United States
24NCT00041327
(ClinicalTrials.gov)
October 20028/7/2002Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/LymphomaPhase 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 LymphomaLymphomaBiological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudineAIDS Malignancy ConsortiumNational Cancer Institute (NCI)Completed18 Years120 YearsBoth19Phase 2United States
25NCT00272480
(ClinicalTrials.gov)
November 8, 19994/1/2006Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised TrialZidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised TrialHTLV-I-associated MyelopathyDrug: Zidovudine/lamivudine;Drug: PlacebosImperial College LondonNULLCompleted16 Years75 YearsAll16Phase 2;Phase 3United Kingdom
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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26NCT00001785
(ClinicalTrials.gov)
September 19983/11/1999Recombinant 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-1aHTLV-I Infection;Spinal Cord Disease;Tropical Spastic ParaparesisDrug: Recombinant human interferon beta-1aNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth12Phase 2United States