Copiktra (duvelisib) / Secura Bio, Yakult Honsha |
ChiCTR2300074621: Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposome Combined With Duvelisib in Patients With Relapsed/Refractory PTCL and NK/T |
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| Not yet recruiting | 4 | 72 | | Mitoxantrone hydrochloride liposome and Duvelisib; Mitoxantrone hydrochloride liposome and Duvelisib | Shandong Cancer Hospital; Shandong Cancer Hospital, CSPC Ouyi Pharmaceutical Co., Ltd. | lymphoma | | | | |
| Recruiting | 4 | 20 | | Duvelisib and Chidamide in combination with CHOP regimen | The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University, Self-funded | Angioimmunoblastic T cell lymphoma | | | | |
2013-002405-61: Study to assess the safety and efficacy of the study drug IPI-145/Duvelisib in Leukaemia patients compared with Ofatumumab |
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| | 3 | 80 | Europe | Duvelisib, ARZERRA, Duvelisib, Ofatumumab, Ofatumumab | Infinity Pharmaceuticals, Inc, Infinity Pharmaceuticals, Inc | Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | | | | |
2013-003639-31: Study to assess the safety of the study drug IPI-145/Duvelisib or ofatumumab in leukemia patients |
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| | 3 | 36 | Europe | Duvelisib, ARZERRA, Duvelisib, L01XC10, OFATUMUMAB, OFATUMUMAB | Infinity Pharmaceuticals, Inc, Infinity Pharmaceuticals, Inc | Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma | | | | |
TERZO, NCT06522737: A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype |
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| Not yet recruiting | 3 | 124 | NA | Duvelisib, Gemcitabine, Bendamustine | SecuraBio | Lymphoma | 02/28 | 12/28 | | |
| Completed | 2 | 129 | Europe, Canada, US, RoW | Duvelisib, Copiktra, IPI-145 | SecuraBio | Indolent Non-Hodgkin Lymphoma | 11/20 | 11/20 | | |
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ChiCTR2000032427: Clinical study of Duvelisib in subjects with relapsed and refractory follicular lymphoma |
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| Not yet recruiting | 2 | 57 | | Duvelisib | Ruijin Hospital, Shanghai Jiaotong University School of Medicine; CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. | relapsed and refractory follicular lymphoma | | | | |
| Completed | 2 | 103 | Europe, US, RoW | Duvelisib, Copiktra, VS-0145, IPI-145 | SecuraBio | Indolent Non-Hodgkin Lymphoma | 07/23 | 07/23 | | |
| Completed | 2 | 103 | Europe, US | Duvelisib | SecuraBio | Peripheral T-cell Lymphoma | 12/23 | 12/23 | | |
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NCT05057247: Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC |
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| Active, not recruiting | 2 | 26 | US | Duvelisib, VS-0145, Docetaxel, Taxotere | Glenn J. Hanna, Secura Bio, Inc. | Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent Squamous Cell Carcinoma of the Head and Neck, Metastatic Head and Neck Cancer, Advanced Head and Neck Cancer, Advanced Head and Neck Squamous Cell Carcinoma | 10/23 | 01/25 | | |
NCT05976997: Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL) |
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| Recruiting | 2 | 36 | RoW | Duvelisib, Chidamide | Liling Zhang, CSPC Ouyi Pharmaceutical Co., Ltd. | Newly Diagnosed Peripheral T-cell Lymphoma | 12/23 | 12/24 | | |
NCT03961672: Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
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| Active, not recruiting | 2 | 15 | US | Duvelisib, 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI-145 | City of Hope Medical Center, National Cancer Institute (NCI) | Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma | 07/23 | 12/24 | | |
A051902, NCT04803201: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma |
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| Recruiting | 2 | 170 | US | Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Etoposide, Duvelisib, Oral azacitidine | Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI) | Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Follicular T-Cell Lymphoma, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype, Peripheral T-Cell Lymphoma, Not Otherwise Specified | 06/25 | 01/26 | | |
NCT04331119: Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas |
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| Active, not recruiting | 2 | 17 | US | Duvelisib, Copiktra, Peripheral blood draw | Washington University School of Medicine, SecuraBio | T-Cell Lymphoma | 07/26 | 07/26 | | |
NCT02158091: A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL |
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| Active, not recruiting | 1/2 | 32 | US | IPI-145, Fludarabine, Fludara, Cyclophosphamide, Cytoxan®, Neosar®, Rituximab, Rituxan | Dana-Farber Cancer Institute, Secura Bio, Inc. | Chronic Lymphocytic Leukemia | 10/17 | 07/25 | | |
NCT03534323: Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS |
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| Active, not recruiting | 1/2 | 67 | US | Duvelisib, IPI-145, Venetoclax, Venclexta | Dana-Farber Cancer Institute, Secura Bio, Inc. | Chronic Lymphocytic Leukemia, Richter Syndrome | 12/24 | 07/26 | | |
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NCT05508659: A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors |
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| Not yet recruiting | 1/2 | 128 | NA | Duvelisib, COPIKTRA, SG001, Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Advanced Solid Tumors | 09/24 | 03/25 | | |
| Recruiting | 1/2 | 264 | RoW | CHOP+selinexor+5-Azacitidine, CHOP+duvelisib+5-Azacitidine, CHOP+chidamide+tislelizumab, standard CHOP | Ruijin Hospital, The First Affiliated Hospital of Nanchang University, Peking University Third Hospital, Wuhan TongJi Hospital, West China Hospital, Nanfang Hospital, Southern Medical University, Anhui Provincial Cancer Hospital, The First Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhengzhou University, Beijing Tongren Hospital, Peking University People's Hospital, Sun Yat-sen University, The First Affiliated Hospital of Anhui Medical University, The First Hospital of Jilin University | Peripheral T Cell Lymphoma | 07/26 | 07/28 | | |
NCT04688658: Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma |
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| Active, not recruiting | 1/2 | 13 | US | Nivolumab, Opdivo, AG013736, Duvelisib, Copiktra | John Kirkwood, Secura Bio, Inc., Bristol-Myers Squibb | Unresectable Melanoma | 02/24 | 12/28 | | |
NCT03892044: Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma |
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| Completed | 1 | 7 | US | Duvelisib, 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, INK-1197, IPI-145, Nivolumab, BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo | David Bond, MD | Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Richter Syndrome, Small Lymphocytic Lymphoma, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma | 02/24 | 02/24 | | |
NCT02783625: Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas |
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| Active, not recruiting | 1 | 114 | US | Romidepsin, Bortezomib, duvelisib, IPI-145 | Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, Stanford University | Lymphoma, Relapsed/Refractory T-cell Lymphomas | 05/25 | 05/25 | | |
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NCT04890236: Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study |
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| Recruiting | 1 | 20 | US | Duvelisib, 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI-145, Tisagenlecleucel, CART-19, CART19, CTL019, CTL019 T-cells, Kymriah, Tisagenlecleucel-T | Emory University, National Cancer Institute (NCI), Secura Bio, Inc., Novartis | Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma | 08/24 | 08/25 | | |
NCT04652960: Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome |
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| Recruiting | 1 | 38 | US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Duvelisib, 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI 145, IPI-145, IPI145, Nivolumab, ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Punch Biopsy, BIOPSY, PUNCH, Punch Biopsy of Skin | National Cancer Institute (NCI) | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8 | 05/25 | 05/25 | | |
NCT05044039: Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy |
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| Recruiting | 1 | 43 | US | Duvelisib | Washington University School of Medicine, SecuraBio, The Foundation for Barnes-Jewish Hospital, National Cancer Institute (NCI) | Non-hodgkin Lymphoma, Acute Lymphocytic Leukemia | 12/25 | 05/30 | | |
NCT05010005: A Study of Ruxolitinib and Duvelisib in People With Lymphoma |
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| Active, not recruiting | 1 | 49 | US | Ruxolitinib, Duvelisib | Memorial Sloan Kettering Cancer Center | T-cell Lymphomas, NK-Cell Lymphomas, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocyte Leukemia | 08/25 | 08/25 | | |
NCT05065866: Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy |
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| Active, not recruiting | 1 | 14 | US | BMS-986345, Oral Azacitidine, Duvelisib, Copiktra | H. Lee Moffitt Cancer Center and Research Institute, Secura Bio, Inc. | Non Hodgkin Lymphoma, Hodgkin Lymphoma, Myeloma, Lymphocytic Leukemia | 01/24 | 01/25 | | |
ChiCTR2300074093: Prospective, single arm, single center study of Duvaliser combined with Cedarbamide in the treatment of newly treated peripheral T-cell lymphoma (PTCL) |
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| Not yet recruiting | N/A | 36 | | duvelisib+Chidamide | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, CSPC OUYI PHARMACEUTICAL CO., LTD. | peripheral T-cell lymphoma (PTCL) | | | | |
NCT05923502: (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL) |
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| Not yet recruiting | N/A | 200 | NA | Duvelisib, Copiktra | Ruijin Hospital | Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome, Marginal Zone Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma | 11/27 | 11/27 | | |
Zilretta (triamcinolone acetonide ER) / Pacira |
NCT05492851: Trial Comparing Three Single Dose Injections for Knee Osteoarthritis |
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| Terminated | 4 | 6 | US | Zilretta, Synvisc-One 48 MG in 6 ML Prefilled Syringe, Monovisc 88 MG Per 4 ML Prefilled Syringe | Ohio State University | Osteoarthritis, Knee | 01/23 | 01/23 | | |
| Enrolling by invitation | 4 | 150 | US | Zilretta Injectable Product or Placebo, triamcinolone acetonide | The Cleveland Clinic, Arthritis Foundation | Osteoarthritis, Knee, Meniscus Tear, Meniscus; Degeneration, Synovitis | 03/25 | 05/25 | | |
NCT06478186: Knee Osteoarthritis Treatment with Zilretta Vs. Kenalog in the Context of Type II Diabetes |
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| Recruiting | 4 | 120 | US | triamcinolone acetonide extended-release injectable suspension; TCA-ER, Triamcinolone Acetonide- Immediate Release;TCA-IR | University of Kansas Medical Center | Osteoarthritis, Knee, Diabetes Mellitus, Type 2 | 07/26 | 07/26 | | |
NCT04094298: Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease |
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| Recruiting | 3 | 65 | US | FX006 Injection, No other interventions | Northwell Health | Rotator Cuff Tears, Rotator Cuff Tendinitis, Rotator Cuff Impingement, Injections, Glucocorticoids | 12/24 | 12/24 | | |
NCT06269705: ZILRETTA in Subjects With Shoulder Osteoarthritis |
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| Recruiting | 3 | 250 | US | ZILRETTA, TCA-IR, Placebo, Normal Saline | Pacira Pharmaceuticals, Inc | Glenohumeral Osteoarthritis | 08/25 | 08/25 | | |
NCT04182672: Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis |
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| Completed | 2 | 22 | US | FX006 | The University of Texas Health Science Center, Houston, Pacira Pharmaceuticals | Trochanteric Bursitis | 12/22 | 12/22 | | |
NCT04885972: Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis |
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| Active, not recruiting | 2 | 124 | US | Resiniferatoxin, RTX, Zilretta, triamcinolone acetonide, Placebo | Sorrento Therapeutics, Inc. | Osteoarthritis, Knee, Knee Osteoarthritis, Knee Pain Chronic | 09/23 | 11/23 | | |
NCT06237153: Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis |
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| Recruiting | 2 | 30 | US | Triamcinolone Acetonide extended release suspension | Marie Badalamente | Carpometacarpal (CMC) Osteoarthritis | 12/25 | 12/25 | | |
NCT04831255: ZILRETTA™ for Treatment of Idiopathic Adhesive Capsulitis |
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| Recruiting | 1 | 50 | US | triamcinolone acetonide extended-release injectable suspension, ZILRETTA | University of Virginia | Adhesive Capsulitis, Frozen Shoulder, Adhesive Capsulitis of Shoulder | 07/23 | 12/23 | | |
batoclimab (IMVT-1401) / Roivant |
2021-000249-42: Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with gMG Studio di fase 3 per valutare l’efficacia e la sicurezza di Batoclimab come terapia di induzione e di mantenimento in partecipanti adulti affetti da miastenia grave generalizzata (gMG). |
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| Ongoing | 3 | 240 | Europe | Batoclimab, [IMVT-1401], Solution for injection in pre-filled syringe | Immunovant Sciences GmbH, Immunovant Sciences GmbH | Generalized Myasthenia Gravis (gMG) Miastenia grave generalizzata (gMG), Generalized Myasthenia Gravis (gMG) Miastenia grave generalizzata (gMG), Diseases [C] - Nervous System Diseases [C10] | | | | |
MG, NCT05039190: Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized Patients |
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| Completed | 3 | 132 | RoW | HBM9161 Injection (680mg), Placebo | Harbour BioMed (Guangzhou) Co. Ltd. | Myasthenia Gravis | 01/23 | 01/23 | | |
2022-002787-68: Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease Studio di fase 3 per testare Batoclimab in partecipanti affetti da oftalmopatia tiroidea (TED) attiva |
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| Not yet recruiting | 3 | 100 | Europe | Batoclimab, [IMVT-1401], Solution for injection in pre-filled syringe | Immunovant Sciences GmbH, Immunovant Sciences, GmbH, Immunovant Sciences GmbH | Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED) attiva, Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED) attiva, Diseases [C] - Eye Diseases [C11] | | | | |
NCT05332210: Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis |
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| Recruiting | 3 | 144 | RoW | HBM9161 Injection (680mg) | Harbour BioMed (Guangzhou) Co. Ltd. | Myasthenia Gravis | 09/23 | 12/23 | | |
ChiCTR2100050903: Multicenter, randomized, double-blind, placebo-controlled, phase 2/3 operational seamless, group sequential design study of the efficacy and safety of HBM9161 subcutaneous injection in patients with generalized myasthenia gravis |
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| Not yet recruiting | 3 | 144 | | HBM9161 ;Placebo | Huashan Hospital Affiliated to Fudan University; Harbour BioMed (Suzhou) Co., Ltd., self-funded | Myasthenia Gravis | | | | |
NCT05403541: Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis |
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| Active, not recruiting | 3 | 240 | Europe, Canada, Japan, US, RoW | Batoclimab 680 mg SC weekly, IMVT-1401, Batoclimab 340 mg SC weekly, Matching Placebo SC, Batoclimab 340 mg SC bi-weekly | Immunovant Sciences GmbH | Generalized Myasthenia Gravis | 03/25 | 04/25 | | |
ChiCTR2200059452: A long-term open-label extension study to evaluate the safety of HBM9161 (HL161) subcutaneous injection in patients with generalized myasthenia gravis |
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| Not yet recruiting | 3 | 144 | | HBM9161 680 mg was administered once a week (QW) ;HBM9161 340mg was administered 6 times per cycle for two cycles | Huashan Hospital Affiliated to Fudan University; Harbour BioMed (Suzhou) Co., Ltd., self-funded | Myasthenia gravis | | | | |
NCT05517421: Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease |
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| Recruiting | 3 | 100 | Europe, Canada, Japan, US, RoW | Batoclimab, IMVT-1401, Placebo | Immunovant Sciences GmbH | Thyroid Eye Disease | 12/24 | 01/25 | | |
| Recruiting | 3 | 100 | Europe, US, RoW | Batoclimab, IMVT-1401, Placebo | Immunovant Sciences GmbH, Immunovant Sciences GmbH | Thyroid Eye Disease | 12/24 | 01/25 | | |
| Recruiting | 3 | 180 | Europe, US, RoW | Observational cohort study, Batoclimab, IMVT-1401 | Immunovant Sciences GmbH, Immunovant Sciences GmbH | Thyroid Eye Disease | 05/25 | 06/25 | | |
NCT04428255: A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP |
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| Recruiting | 2/3 | 36 | RoW | HBM9161 Dose A, HBM9161 Dose B, Placebo | Harbour BioMed (Guangzhou) Co. Ltd. | Primary Immune Thrombocytopenic Purpura | 07/21 | 03/23 | | |
NCT05015127: A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease |
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| Recruiting | 2/3 | 36 | RoW | HBM9161 680 mg qw by q2w from week 13, Placebo, HBM9161 680 mg qw by q2w from week 7 | Harbour BioMed (Guangzhou) Co. Ltd. | Thyroid Ophthalmopathy | 10/22 | 12/22 | | |
| Not yet recruiting | 2 | 30 | | HBM9161 dose 1 ;HBM9161 dose 2 ;Placebo | Huashan Hospital Affiliated to Fudan University; Harbour BioMed (Suzhou) Co., Ltd, Harbour BioMed (Guangzhou) Co., Ltd | Myasthenia Gravis | | | | |
ChiCTR2100050401: A randomized, double-blind, placebo-controlled, phase 2/3 operational seamless design clinical study to evaluate the efficacy and safety of subcutaneous injection of HBM9161 in Chinese patients with active, moderate-to-severe thyroid eye disease (TED) |
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| Not yet recruiting | 2 | 30 | | HBM9161 Once a week ;HBM9161 1 time / week + 2 times / week ;Placebo | Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Harbour BioMed(Suzhou) Co., Ltd., Harbour BioMed(Suzhou) Co., Ltd. | Thyroid Eye Disease (TED) | | | | |
2022-002894-27: Graves' disease is an immune system disorder that results in the overproduction of thyroid hormones. |
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| Not yet recruiting | 2 | 45 | Europe | batoclimab, IMVT-1401, Solution for injection in pre-filled syringe | Immunovant Sciences GmbH, Immunovant Sciences GmbH | Graves, disease, An immune system disorder that results in the overproduction of thyroid hormones (hyperthyroidism)., Diseases [C] - Immune System Diseases [C20] | | | | |
NCT05907668: A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease |
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| Recruiting | 2 | 45 | Europe | IMVT-1401 (batoclimab), IMVT-1401 | Immunovant Sciences GmbH | Graves Disease | 11/24 | 05/25 | | |
| Recruiting | 2 | 277 | Europe, Canada, US, RoW | Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly, IMVT-1401, Batoclimab 340 mg SC weekly, Placebo | Immunovant Sciences GmbH, Immunovant Sciences, GmbH | Chronic Inflammatory Demyelinating Polyneuropathy | 01/26 | 01/27 | | |
ChiCTR2000029151: Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of HBM9161 weekly subcutaneous administration in patients with neuromyelitis optica spectrum disorders (NMOSD) in China. |
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| Recruiting | 1 | 18 | | HBM9161 | The Third Affiliated Hospital, Sun Yat-Sen Unvierity; Harbour BioMed (Guangzhou) Co., Ltd, Harbour BioMed (Guangzhou) Co., Ltd | Neuromyelitis optica spectrum disorders | | | | |
Anpingxi (ripertamab) / Sinocelltech |
NCT06405100: Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD |
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| Not yet recruiting | 3 | 81 | NA | Supportive care+Prednisone, Control group, Supportive care+Tacrolimus+Ripertamab, Test group 1, Supportive care+Ripertamab, Test group 2 | Air Force Military Medical University, China, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Air Force Military Medical University, Shaanxi Provincial People's Hospital, Shaanxi Provincial Hospital of Chinese Medicine | Minimal Change Disease | 04/26 | 04/27 | | |
ChiCTR2400087275: Efficacy and Safety of Ripertamab With or Without Other Drugs in B-cell Non-Hodgkin's Lymphomas |
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| Recruiting | N/A | 400 | | none | Institute of Hematology and Oncology, Harbin The First Hospital; Institute of Hematology and Oncology, Harbin The First Hospital, self-raised | Lymphomas | | | | |
ruserontinib (SKLB-1028) / CSPC Pharma |
ALIVE, NCT04716114: A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated |
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| Recruiting | 3 | 315 | RoW | SKLB1028, Salvage Chemotherapy, cytarabine, azacytidine, fludarabine, homoharringtonine, aclarubicin | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Acute Myeloid Leukemia (AML) | 12/25 | 12/25 | | |
ChiCTR2000041448: A Phase 3, Open-Label, Multicenter, Randomized Study of SKLB1028 versus Salvage Chemotherapy in Patients with FLT3-mutated Acute Myeloid Leukemia Refractory to or Relapsed after First-line Treatment |
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| Recruiting | 3 | 261 | | SKLB1028 ;Control group | West China Hospital of Sichuan University; West China Hospital of Sichuan University, Completely self-financing | Acute myeloid leukemia | | | | |
ChiCTR1900025190: Phase IIa Clinical Study for SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients |
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| Recruiting | 2 | 30 | | Oral sklb1028 capsule 150mg bid ;Oral sklb1028 capsule 200mg bid ;Oral sklb1028 capsule 300mg QD | CSPC ZhongQi Pharmaceutical Technology Co., Ltd; CSPC ZhongQi Pharmaceutical Technology Co., Ltd, Completely self-financing | Acute myeloid leukemia | | | | |
NCT05445154: SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) |
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| Recruiting | 1/2 | 58 | RoW | SKLB1028 Dose Escalation | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Newly Diagnosed Acute Myeloid Leukemia (AML) | 10/24 | 12/26 | | |
NCT05069870: A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects |
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| Active, not recruiting | 1 | 42 | RoW | SKLB1028, Itraconazole, Gemfibrozil, Rifampicin | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Healthy Subjects | 11/21 | 11/21 | | |
NCT05072522: A Study of SKLB1028 in Patients With Advanced Solid Tumor |
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| Not yet recruiting | 1 | 98 | RoW | SKLB1028 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Advanced Solid Tumors | 10/23 | 10/23 | | |
Duoenda (mitoxantrone liposomal) / CSPC Pharma |
ChiCTR2200060047: A Prospective, Single-center, Exploratory Study of Low-Dose Cytarabine, Mitoxantrone Liposome Combined with Granulocyte Colony Stimulating Factor in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia |
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| Recruiting | 4 | 12 | | Cytarabin+ Mitoxantrone Liposome+Granulocyte Colony Stimulating Factor | The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University, CSPC OUYI PHARMACEUTICAL CO., LTD. | Relapsed or Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2200060080: Dose-escalation clinical study of mitoxantrone hydrochloride liposome injection combined with cladribine, cytarabine and granulocyte colony-stimulating factor in the treatment of relapsed or refractory acute myeloid leukemia |
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| Recruiting | 4 | 18 | | Cladribine+Cytarabine+Granulocyte colony-stimulating factor+Mitoxantrone liposome | The Second Affiliated Hospital of the Army Medical University of the PLA; The Second Affiliated Hospital of the Army Medical University of the PLA, NA | Relapsed or Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2300073448: Clinical study of mitoxantrone hydrochloride liposome injection combined with rituximab and bendamustine (RMB) in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a single-arm, single-center, prospective phase Ib |
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| Not yet recruiting | 4 | 12 | | Different doses of mitoxantrone hydrochloride liposome injection and fixed doses of rituximab, bendamustine | Chongqing University Cancer Hospital; Chongqing University Cancer Hospital, none | Relapsed and refractory diffuse large B-cell lymphoma | | | | |
ChiCTR2200063308: A Prospective, Single-center and Exploratory Study of Hartaxidine and Cytarabine Combined with Mitoxantrone Liposome in The Treatment of Relapsed and Refractory Acute Myeloid Leukemia |
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| Not yet recruiting | 4 | 65 | | hartaxidine and cytarabine combined with mitoxantrone liposome | Tianjin Medical University General Hospital; Tianjin Medical University General Hospital, Beijing Cancer Prevention&Treatment Society | Relapsed or Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2200060085: Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection Combined with Cytarabine and Etoposide in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia |
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| Recruiting | 4 | 18 | | Mitoxantrone Liposome + Cytarabine + Etoposide | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, CSPC OUYI PHARMACEUTICAL CO., LTD. | Relapsed or Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2300067964: Clinical study on pharmacokinetics of Mitoxantrone hydrochloride liposome injection combined with cytarabine in children with newly diagnosed acute myeloid leukemia |
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| Not yet recruiting | 4 | 8 | | Mitoxantrone liposome combined with cytarabine ± etoposide | Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, CSPC Ouyi Pharmaceutical Co., Ltd. | Children with newly diagnosed acute myeloid leukemia | | | | |
ChiCTR2200067172: Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Acute Myeloid Leukemia: a Multicenter, Non-Interference, Two-Way Cohort Real World Study |
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| Not yet recruiting | 4 | 200 | | mitoxantrone hydrochloride liposome | Institute of Hematology&Oncology, Harbin First Hospital; Institute of Hematology&Oncology, Harbin First Hospi, CSPC Ouyi Pharmaceutical Co., Ltd. | Acute Myeloid Leukemia | | | | |
ChiCTR2200062067: Efficacy and safety of Liposomal Mitoxantrone Hydrochloride in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Multicenter, Non- Interventional and Ambispective Cohort Real-World Study |
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| Not yet recruiting | 4 | 500 | | none | Harbin Institute of Hematology and Oncology/ Beijing Cancer Hospital/ Cancer Prevention and Treatment Center of Sun Yat-Sen University ; Harbin Institute of Hematology and Oncology, CSPC OUYI PHARMACEUTICAL CO., LTD. | Peripheral T-cell Lymphoma | | | | |
ChiCTR2300070019: Prospective, multicenter and exploratory study of mitoxantrone hydrochloride liposome injection combined with cytarabine in the treatment of primary secondary acute myeloid leukemia in the elderly patients |
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| Not yet recruiting | 4 | 60 | | mitoxantrone hydrochloride liposome + cytarabine | Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, CSPC Ouyi Pharmaceutical Co., Ltd. | Acute Myeloid Leukemia | | | | |
ChiCTR2400087424: To observe the outcome of mitoxantrone liposome combined with VPD/KPD regimen (bortezomib/Carfilzomib, pomadomide, dexamethasone) in the treatment of multiple myeloma with plasmacytoma: a multicenter real-world clinical study |
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| Recruiting | 4 | 70 | | | Beijing Chaoyang Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University, Fully self-raised | multiple myeloma with plasmacytoma | | | | |
ChiCTR2300075418: Clinical study of Mitoxantrone liposome, Azacitidine and Chidamide in the treatment of angioimmunoblastic T-cell lymphoma (AITL) |
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| Recruiting | 4 | 45 | | Mitoxantrone liposome, Azacitidine and Chidamide | Shanxi Cancer Hospital/Cancer Hospital of the Chinese Academy of Medical Sciences, Shanxi Hospital; Shanxi Cancer Hospita, Corporate Sponsorship | Angioimmunoblastic T-cell lymphoma | | | | |
ChiCTR2400086291: A prospective, multi-center clinical study of mitoxantrone hydrochloride liposome injection combined with cladribine, cytarabine and granulocyte colony-stimulating factor in the treatment of relapsed and refractory acute myeloid leukemia |
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| Not yet recruiting | 4 | 50 | | Cladribine+Cytarabine+Granulocyte colony-stimulating factor+Mitoxantrone liposome | The Second Affiliated Hospital of the Army Medical University of the PLA; The Second Affiliated Hospital of the Army Medical University of the PLA | Relapsed or Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2400086528: A prospective, single-center, exploratory study of mitoxantrone hydrochloride liposome injection combined with standard-dose cytarabine and venetoclax in the treatment of relapsed/refractory acute myeloid leukemia |
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| Not yet recruiting | 4 | 20 | | Mitoxantrone hydrochloride liposome+standard-dose cytarabine+venetoclax | The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University, CSPC OUYI PHARMACEUTICAL CO., LTD. | Relapsed/Refractory Acute Myeloid Leukemia | | | | |
ChiCTR2400080919: An exploratory clinical study of mitoxantrone hydrochloride liposome injection and cytarabine combined with etoposide in the treatment of newly diagnosed de novo acute myeloid leukemia |
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| Not yet recruiting | 4 | 55 | | Mitoxantrone hydrochloride liposome injection and Cytarabine combined with Etoposide | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, CSPC Pharmaceutical (Shijiazhuang) Co., Ltd | Acute myeloid leukemia | | | | |
| Recruiting | 4 | 15 | | Azacitidine and Chidamide in combination with Mitoxantrone Hydrochloride Liposome | The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University, Self-funded | Angioimmunoblastic T cell lymphoma | | | | |
ChiCTR2400091259: A prospective, single-center, single-arm study of mitoxantrone hydrochloride liposome injection combined with venetoclax and azacitidine in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia |
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| Not yet recruiting | 4 | 40 | | mitoxantrone hydrochloride liposome+venetoclax+azacitidine | General Hospital of Chinese People's Liberation Army Northern Theater Command; General Hospital of Chinese People's Liberation Army Northern Theater Command, self-financed | Acute Myeloid Leukemia | | | | |
ChiCTR2400084237: A prospective, multi-center, randomized controlled clinical study of mitoxantrone liposome-based three-drug combination regimen for the treatment of relapsed and refractory acute myeloid leukemia |
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| Not yet recruiting | 4 | 100 | | Liposomal mitoxantrone combined with venetoclax and azacitidine; venetoclax combined with azacitidine. | Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology; Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology, Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology | acute myeloid leukemia | | | | |
NCT06345365: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) |
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| Recruiting | 3 | 154 | RoW | mitoxantrone liposome, Ara-Cytarabine and azacitidine, Daunorubicin,Ara-Cytarabine, azacitidine | Zhongnan Hospital, Ruijin Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Zhengzhou University, Jingzhou Central Hospital, Yichang Central People's Hospital, Taihe Hospital, The Central Hospital of Xiaogan, Xianning Central Hospital, The First People's Hospital of Jingzhou | Acute Myeloid Leukaemia | 12/26 | 12/28 | | |
NCT05717764: Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Treatment |
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| Not yet recruiting | 3 | 500 | NA | Mitoxantrone hydrochloride liposome injection, Capecitabine | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Recurrent Metastatic Nasopharyngeal Carcinoma | 09/26 | 09/27 | | |
NCT04668690: Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL |
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| Not yet recruiting | 3 | 190 | RoW | Mitoxantrone Hydrochloride Liposome Injection, HE071, Liposomal Mitoxantrone Hydrochloride Injection, Chidamide | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Peripheral T Cell Lymphoma | 12/27 | 12/28 | | |
NCT05739630: M-PTCy vs BuCy in Haploidentical HSCT for Acute Leukemia |
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| Recruiting | 2/3 | 60 | RoW | mitoxantrone liposome, Fludarabine,Cytarabine,busulfan,Cyclophosphamide,MMF,Tacrolimus Capsules, ATG, MECCNU,Hu,Cytarabine,busulfan,Cyclophosphamide,MTX,CsA | The First Affiliated Hospital of Soochow University | Acute Leukemia | 01/24 | 01/25 | | |
NCT04927481: A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer |
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| Terminated | 2 | 28 | RoW | Mitoxantrone Hydrochloride Liposome Injection | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Breast Cancer | 01/23 | 01/23 | | |
ChiCTR2000032830: A Study of PLM60 in Subjects With Relapsed Small-Cell Lung Cancer After Platinum-Based First-Line Chemotherapy |
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| Not yet recruiting | 2 | 81 | | 20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle ;15 mg/m2, 3 weeks/cycle, administered on day 1 of each cycle | West China Hospital of Sichuan University; Level of the institution:, CSPC Zhongqi Pharmaceutical Technology Co., Ltd. | Small cell lung cancer | | | | |
NCT05495100: A Single-arm, Multicenter, Prospective Clinical Study of Mitoxantrone Liposome Combined With Chidamide and Azacitidine in the Treatment of Relapsed and Refractory Peripheral T-cell Lymphoma |
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| Recruiting | 2 | 45 | RoW | Mitoxantrone liposome、Chidamide、Azacitidine | Second Affiliated Hospital, School of Medicine, Zhejiang University, Ningbo No. 1 Hospital, Jinhua Central Hospital, Huizhou Municipal Central Hospital | Peripheral T Cell Lymphoma | 08/23 | 08/24 | | |
NCT05100329: A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer |
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| Not yet recruiting | 2 | 38 | NA | Mitoxantrone Hydrochloride Liposome injection | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Advanced Pancreatic Cancer | 11/23 | 05/24 | | |
NCT05823701: Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients |
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| Recruiting | 2 | 23 | RoW | Chidamide, Tucidinostat, Azacitidine, AZA, obinutuzumab, Gazyva, Liposomal mitoxantrone, PLM60 | The First Affiliated Hospital of Soochow University | Diffuse Large B-Cell Lymphoma | 12/23 | 12/25 | | |
GMCAII, NCT06221683: Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML |
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| Recruiting | 2 | 500 | RoW | Homoharringtonine, Homoharringtonine injection, Cytarabine, Cytosar, Etoposide, Etoposide injection, Venetoclax, Venclexta, Mitoxantrone hydrochloride liposome, Mitoxantrone hydrochloride liposome injection, Recombinant Human Granulocyte Colony-Stimulating Factor, Recombinant Human Granulocyte Colony-Stimulating Factor Injection, Idarubicin Hydrochloride, Idarubicin hydrochloride injection, Sorafenib, Nexavar, Gilteritinib, Xospata Pill, Avapritinib, AYVAKIT | Children's Hospital of Soochow University | AML, Childhood, Acute Myeloid Leukemia | 12/28 | 12/29 | | |
NCT06244368: GVM±R in Patients With Relapsed or Refractory Aggressive NHL. |
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| Recruiting | 2 | 115 | RoW | GVM±R regimen | Qiu Lugui | Peripheral T Cell Lymphoma, Diffuse Large B-cell Lymphoma | 06/25 | 06/27 | | |
NCT06220097: Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies |
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| Recruiting | 2 | 28 | RoW | Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells | Wuhan Union Hospital, China, CSPC Pharmaceutical Group Limited | B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma Refractory | 08/24 | 12/25 | | |
NCT06434662: Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML |
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| Recruiting | 2 | 34 | RoW | mitoxantrone hydrochloride liposome, Cytarabine, Venetoclax | First Affiliated Hospital of Zhejiang University, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy | 06/25 | 06/26 | | |
NCT05774028: Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal NK/T-cell Lymphoma |
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| Not yet recruiting | 2 | 50 | NA | Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) regimen | The First Affiliated Hospital with Nanjing Medical University | NK-T-Cell Lymphoma, Extranodal | 04/24 | 04/25 | | |
| Recruiting | 2 | 30 | RoW | Mitoxantrone hydrochloride liposome, Venetoclax, Cytarabine,Cytosine arabinoside, Cyclophosphamide | Institute of Hematology & Blood Diseases Hospital, China | Relapse Acute Myeloid Leukemia | 05/27 | 10/27 | | |
NCT06489808: Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL |
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| Recruiting | 2 | 89 | RoW | Linperlisib, Rituximab, Gemcitabine, Oxaliplatin, Ifosfamide, Carboplatin, Etoposide, Dexamethasone, Cisplatin, Ara-C, Vinorelbine, Mitoxantrone hydrochloride liposome | Institute of Hematology & Blood Diseases Hospital, China | Relapsed/Refractory Large B-Cell Lymphoma | 12/26 | 05/27 | | |
NCT06433362: CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma |
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| Recruiting | 2 | 115 | RoW | CMOEP | Tianjin Medical University Cancer Institute and Hospital | Peripheral T Cell Lymphoma | 06/25 | 06/26 | | |
NCT06472713: Clinical Study of Mitoxantrone Hydrochloride Liposome Combined With PD-1 Blockade in Recurrent or Metastatic NPC |
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| Not yet recruiting | 2 | 32 | NA | Mitoxantrone hydrochloride liposome injection, PD-1 blockade | Ming-Yuan Chen | Recurrent or Metastatic Nasopharyngeal Carcinoma | 10/25 | 09/27 | | |
NCT06514313: Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma. |
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| Recruiting | 2 | 110 | RoW | Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine, Temozolomide+Irinotecan+Vincristine | Yizhuo Zhang | Soft Tissue Sarcoma | 08/26 | 12/26 | | |
NCT06621199: Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML |
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| Recruiting | 2 | 42 | RoW | Mitoxantrone hydrochloride liposome, Cytarabine, Venetoclax | First Affiliated Hospital of Zhejiang University, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Acute Myeloid Leukemia | 12/27 | 12/27 | | |