Reblozyl (luspatercept-aamt) / BMS, Merck (MSD) |
NCT05462548: The Safety and Efficiency of Luspatercept in Chinese Adults With Transfusion Dependent β-thalassemia: a Real-world Study |
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| Recruiting | 4 | 20 | RoW | Luspatercept Injectable Product, luspatercept | Sun Yat-sen University | Thalassemia Major, Transfusion-dependent Anemia | 02/23 | 04/23 | | |
ChiCTR2300070683: Prospective, single arm, multicenter clinical study on the efficacy and safety of luspatercept combined with recombinant human erythropoietin in the treatment of low-risk myelodysplastic syndromes with anemia |
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| Not yet recruiting | 4 | 52 | | Treatment | The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University, Self-raised | Myelodysplastic syndromes | | | | |
NCT06424639: Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA |
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| Not yet recruiting | 4 | 58 | RoW | Luspatercept, cyclosporine | Peking Union Medical College Hospital | Aplastic Anemia | 05/25 | 12/25 | | |
| Not yet recruiting | 4 | 95 | | N/A | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Bristol-Myers Squibb (China) Investent Co., Ltd., Bristol-Myers Squibb (China) Investment Co., Ltd. | thalassemia | | | | |
NCT06006949: Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory MDS-RS |
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| Not yet recruiting | 4 | 62 | RoW | Roxadustat, Luspatercept | Peking Union Medical College Hospital | Myelodysplastic Syndromes | 08/24 | 08/25 | | |
ChiCTR2300076920: Luspatercept for the treatment of anaemia with mild to moderate beta-thalassemia in China |
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| Not yet recruiting | 4 | 70 | | Luspatercept 1.0mg/kg, injection every 21 days | West China Hospital, Sichuan University; West China Hospital Sichuan University, Beijing Life Oasis Public Welfare Service Center | Beta thalassemia | | | | |
NCT05891249: A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India |
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| Recruiting | 4 | 60 | RoW | Luspatercept, ACE-536, REBLOZYL, BMS-986346, ROJUZDA | Bristol-Myers Squibb | Anemia | 02/26 | 04/26 | | |
2020-004899-18: Determination of the effectiveness and safeness of the drug luspatercept in patients who suffering from a low risk type of cancer when blood-forming cells in the bone marrow become abnormal and having characterized by decreased red blood cells below normal. |
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| Not yet recruiting | 3 | 70 | Europe | ACE-536, Lyophilisate for solution for injection, Reblozyl® 25 mg, Reblozyl® 75 mg | GWT-TUD GmbH, Celgene International II Sàrl. | Lower-risk myelodysplastic syndrome with ring-sideroblastic phenotype (MDS-RS), Patients whose suffering from low risk blood cancer characterized by decreased red blood cells below normal., Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
COMMANDS, NCT03682536 / 2017-003190-34: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve |
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| Active, not recruiting | 3 | 363 | Europe, Canada, Japan, US, RoW | Luspatercept, ACE-536, Epoetin alfa, EPREX®, ERYPO®, PROCRIT® | Celgene, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Myelodysplastic Syndromes | 03/23 | 09/27 | | |
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| Recruiting | 3 | 70 | Europe | Luspatercept, Reblozyl | GWT-TUD GmbH, Celgene | Myelodysplastic Syndromes | 12/24 | 06/25 | | |
INDEPENDENCE, NCT04717414 / 2020-000607-36: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions |
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| Active, not recruiting | 3 | 309 | Europe, Canada, Japan, US, RoW | ACE-536, Luspatercept, BMS-986346, Placebo | Celgene, Celgene Corporation | Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Anemia | 05/25 | 02/29 | | |
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| Recruiting | 3 | 100 | Europe, US, RoW | Luspatercept, BMS-986346, ACE-536, REBLOZYL | Bristol-Myers Squibb | Myelodysplastic Syndromes | 01/26 | 12/27 | | |
ChiCTR2400082173: Clinical study of low-dose decitabine with granulocyte stimulating factor combined with Luspatercept to prevent relapse after high-risk acute myeloid leukemia transplantation |
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| Not yet recruiting | 3 | 102 | | Luspatercept: From 60 days after transplantation, Luspatercept started at 1.0 mg / kg, up-regulated Luspatercept according to the instructions, Q3W, one month before decitabine + G-CSF; After 1 month, G-CSF 5ug / Kgd 0-5, decitabine 10mg * d1-5. Cycle every 2 months, 6 to 8 cycles. | Xinqiao Hospital of Army Medical University; Xinqiao Hospital of Army Medical University, National key research and development program "stem cell research and organ repair" key project (2022YFA1103304) | Acute myeloid leukemia | | | | |
ELEMENT-MDS, NCT05949684: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions |
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| Recruiting | 3 | 360 | Europe, Canada, Japan, US, RoW | Luspatercept, BMS-986346, ACE-536, Reblozyl®, Epoetin Alfa, Epogen®, PROCRIT®, BINOCRIT | Bristol-Myers Squibb | Myelodysplastic Syndromes | 06/27 | 03/30 | | |
| Recruiting | 3 | 665 | Europe, Canada, Japan, US, RoW | Luspatercept, ACE-536 | Celgene | Myelodysplastic Syndromes (MDS), Beta-thalassemia, Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis | 05/28 | 05/28 | | |
NCT03900715: An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion |
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| Completed | 2 | 21 | Japan | Luspatercept | Celgene | Myelodysplastic Syndromes | 07/22 | 03/23 | | |
2021-004928-15: Phase 2 Study of Luspatercept in Adults with Alpha (α)-thalassemia |
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| Ongoing | 2 | 177 | Europe | Luspatercept, ACE-536, Lyophilisate for solution for injection, Reblozyl | Celgene Corporation, Celgene Corporation | Alpha (α)-thalassemia, blood condition resulting in the impaired production of hemoglobin, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
2021-001538-20: Study to evaluate the effect of Luspatercept on transfusion independence of red blood cells (lack of transfusions for 8 consecutive weeks within the first 24 weeks) in subjects with MDS with del (5q) with very low risk, low risk, intermediatedel IPSS-R index and and <5% blasts, resistant / refractory / intolerant to Lenalidomide and dependent on red blood cell transfusions. Studio per valutare l’effetto del Luspatercept sull'indipendenza da trasfusione di globuli rossi (mancanza di trasfusioni per 8 settimane consecutive entro le prime 24 settimane) in soggetti con MDS con del(5q) con indice IPSS-R a rischio molto basso, basso e intermedio e <5% di blasti, resistenti/refrattari/intolleranti alla Lenalidomide e dipendenti da trasfusioni di globuli rossi. |
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| Not yet recruiting | 2 | 22 | Europe | Luspatercept, [ACE-536], Powder for solution for injection, Reblozyl | ASSOCIAZIONE QOL-ONE, Celgene BMS | Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and a bone marrow blast count of < 5% , Refractory or intolerant to, or ineligible for, prior ESA treatment and for prior lenalidomide treatment and who require RBC transfusions. Anemia dovuta a MDS con del5q con IPSS-R MDS a rischio molto basso, basso o intermedio e una conta dei blasti del midollo osseo < 5% , refrattari o intolleranti o non idonei ad un precedente trattamento con agenti stimolanti eritropoietici (ESA) e ad un precedente trattamento con Lenalidomide e che richiedono trasfusioni di RBC, Anemia Due to Myelodysplastic Syndromes with del5q refractory/resistant/intolerant to Prior Treatments, Who Require Red Blood Cell Transfusion. Anemia dovuta alle Sindromi Mielodisplastiche con del5q refrattarie/resistenti/intolleranti a precedenti Trattamenti e che richiedono Trasfusioni di Globuli Rossi, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
NCT05399732: Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia |
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| Not yet recruiting | 2 | 90 | RoW | Luspatercept, ciclosporin | Bing Han | Aplastic Anemia | 01/23 | 07/24 | | |
2020-005736-30: The study is a Phase 2, open-label, multicenter study to determine the efficacy and safety of Luspatercept (ACE-536) in adults with congenital dyserythropoietic anemia type II (CDA II). Lo studio è uno studio di Fase 2, aperto, multicentrico per determinare l'efficacia e la sicurezza di Luspatercept (ACE-536) in soggetti adulti affetti da Anemia Diseritropoietica Congenita tipo II (CDA II). |
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| Not yet recruiting | 2 | 40 | Europe | Luspatercept, [ACE-536], Lyophilisate for solution for injection, Reblozyl | FOndazione per la Ricerca sulle ANemie ed EMoglobinopatie in ItaliA - For Anemia, FOndazione per la Ricerca sulle ANemie ed EMoglobinopatie in ItaliA - For Anemia, Bristol Myers Squibb | Congenital Dyserythropoietic Anemia type II (CDAII) Anemia Diseritropoietica Congenita tipo II (CDA II), Blood disorder that requires infrequent blood transfusions to treat disease-related anemia. Disturbo del sangue che richiede trasfusioni di sangue non frequenti per il trattamento dell’anemia correlata alla malattia., Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
NCT04477850: A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions |
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| Active, not recruiting | 2 | 30 | Japan, RoW | Luspatercept, ACE-536 | Celgene | Myelodysplastic Syndromes | 09/23 | 02/26 | | |
| Recruiting | 2 | 22 | Europe | Luspatercept Injection [Reblozyl] | Associazione Qol-one, Celgene BMS | Myelodysplastic Syndromes, Del(5Q), Anemia, Transfusion-dependent Anemia | 12/24 | 12/29 | | |
NCT05005182: Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts |
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| Terminated | 2 | 3 | US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Hydroxyurea, Droxia, Hydrea, Hydroxycarbamide, Litalir, Onco-Carbide, Oncocarbide, Oxeron, SQ 1089, SQ-1089, Syrea, WR 83799, Luspatercept, ACE-536, Luspatercept-aamt, Reblozyl, Questionnaire Administration | Mayo Clinic | Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified, Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified | 04/23 | 06/23 | | |
NCT05732961: Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms |
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| Active, not recruiting | 2 | 5 | US | Luspatercept, ACE-536 | H. Lee Moffitt Cancer Center and Research Institute, Bristol-Myers Squibb | Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Anemia | 06/25 | 09/25 | | |
ODYSSEY, NCT06517875: Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis |
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| Not yet recruiting | 2 | 56 | NA | Momelotinib, Ojjaara; CYT387, Luspatercept, REBLOZYL; ACE-536 | GlaxoSmithKline | Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis | 08/26 | 08/26 | | |
NCT05567458: A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia. |
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| Active, not recruiting | 2 | 90 | RoW | Luspatercept, ACE-536, BMS-986346, Placebo | Bristol-Myers Squibb | Beta-thalassemia | 02/25 | 07/25 | | |
NCT05664737 / 2021-004928-15: A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia |
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| Recruiting | 2 | 249 | Europe, Canada, RoW | Luspatercept, BMS-986346, ACE-536, REBLOZYL, Placebo | Bristol-Myers Squibb, Celgene Corporation | Anemia | 07/27 | 08/34 | | |
NCT06113302: A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS) |
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| Recruiting | 2 | 40 | US | Luspatercept, ACE-536 | M.D. Anderson Cancer Center | Myelodysplastic Syndromes | 06/26 | 06/26 | | |
| Recruiting | 2 | 99 | Europe, US, RoW | ACE-536, Luspatercept, BMS-986346 | Celgene, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Beta-Thalassemia | 07/27 | 06/35 | | |
NCT05925504: The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes |
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| Recruiting | 2 | 36 | RoW | Luspatercept | Institute of Hematology & Blood Diseases Hospital, China, Beijing Health Alliance Charitable Foundation | Lower Risk MDS Per IPSS-R | 06/26 | 09/26 | | |
LENNON, NCT05384691: Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions |
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| Recruiting | 2 | 213 | Europe | Luspatercept Injection, LUS | University of Leipzig, Celgene Corporation | Myelodysplastic Syndromes, Anemia | 07/26 | 07/27 | | |
ChiCTR2300075883: A phase 2 study to evaluate the efficacy and safety of luspatercept for the treatment of anemia due to myelodysplastic syndromes with SF3B1 mutation in transfusion-dependent patients failed to hypomethylating agents |
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| Not yet recruiting | 2 | 40 | | Luspatercept by subcutaneously injection per 21 days, at a dose of 1 mg/kg titered to a maximum of 1.75 mg/kg | The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital with Nanjing Medical University, National Natural Science Foundation of China; BMS Investigator Sponsored Research | myelodysplastic syndromes | | | | |
ChiCTR2400087725: Selinexor combined with luspatercept in transfusion-dependent patients with bone marrow fibrosis-associated anemia refractory or intolerant to ruxolitinib: a prospective, multi-center, phase 2 study |
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| Recruiting | 2 | 40 | | Upon enrollment, subjects will receive the selinexor combined with luspatercept regimen: the standard dose of selinexor is 20mg twice weekly, and will be reduced to 20mg once weekly when platelet counts <30×109/L are observed. The starting dose level of luspatercept is 1.33 mg/kg every 3 weeks and can be increased to the maximum dose level of 1.75 mg/kg every 3 weeks if no response or disappearance of response is observed. Until at least 24 calendar weeks after the first dosing, unless the subject experiences an unacceptable toxic reaction, withdraws informed consent, or meets any other criteria for discontinuation of treatment. | The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital with Nanjing, None | bone marrow fibrosis-associated anemia | | | | |
2021-000596-37: A randomized phase I/ II multicenter study evaluating combination of luspatercept in LR-MDS without RS having failed or being ineligible to ESA Étude multicentrique de phase I/II randomisée évaluant luspatercept seul ou en association avec l’ASE (Agent Stimulant l’Erythropoïèse) dans les Syndromes Myélodysplasiques de faible risque non sidéroblastiques en échec ou non éligibles aux Agents Stimulants l’érythropoïèse |
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| Ongoing | 1/2 | 150 | Europe | Eprex, Lyophilisate for solution for injection, Solution for injection, Reblozyl, EPREX | Groupe Francophone des Myélodysplasies, Celgene/BMS | Low risk myelodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating Agent Syndromes Myélodysplasiques de faible risque non sidéroblastiques en échec ou non éligibles aux agents stimulants l’érythropoïèse, Low risk myélodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating Agent Syndromes Myelodysplasiques de faible risque non sidéroblastiques en échec ou non éligibles aux agents stimulants l’érythropoïèse, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
NCT05181735: Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA |
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| Recruiting | 1/2 | 150 | Europe | Luspatercept Injection [Reblozyl], ACE-536, Eprex, Epoietin alfa | Groupe Francophone des Myelodysplasies, Celgene | MDS, Myelodysplastic Syndromes | 05/27 | 11/27 | | |
NCT04539236: Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients |
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| Recruiting | 1/2 | 50 | US | Lenalidomide, Revlimid, Luspatercept, Reblozyl, ActRIIB-IgG, ACE-536, 1373715-00-4 | Mikkael Sekeres, MD, Celgene, Bristol-Myers Squibb | Myelodysplastic Syndromes | 08/29 | 08/29 | | |
NCT06670222: Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS) |
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| Not yet recruiting | 1 | 24 | Europe | Arsenic Trioxide (ATO) | Groupe Francophone des Myelodysplasies | Low-risk Myelodysplastic Syndromes | 03/26 | 03/27 | | |
| Completed | N/A | 1 | Canada | Luspatercept, Reblozyl | University Health Network, Toronto | Adult Granulosa Cell Tumor of the Ovary | 08/22 | 08/22 | | |
| Completed | N/A | 215 | Europe | Luspatercept | Fondazione Italiana Sindromi Mielodisplastiche-ETS, Istituto Clinico Humanitas | Myeloid Dysplasia | 12/22 | 01/23 | | |
AIHA ITP CIN, NCT05931718: Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia |
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| Recruiting | N/A | 200 | Europe | cytokine essays, NGS, Fecal microbiome, Erythropoietin, Luspatercept, Thrombopoietin Receptor Agonist, G-CSF | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia, Autoimmune Neutropenia, Myelodysplastic Syndromes, Cold Agglutinin Disease | 09/30 | 06/35 | | |
NCT06164821: Clinical Observation of Luspatercept in Treatment of Chinese Adult β-thalassaemia Patients With TD β-thalassemia |
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| Recruiting | N/A | 10 | RoW | luspatercept | Hematology department of the 920th hospital | Effect of Drug | 01/24 | 11/24 | | |
| Recruiting | N/A | 90 | RoW | Luspatercept | Bristol-Myers Squibb | β-Thalassemia Major | 10/26 | 12/26 | | |
CA056-1083, NCT06581055: A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes |
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| Withdrawn | N/A | 86 | RoW | Luspatercept, Epoetin Alfa | Bristol-Myers Squibb | Myelodysplastic Syndromes (MDS) | 03/25 | 03/25 | | |
ChiCTR2300078105: Luspatercept in the treatment of anemia with myelofibrosis on the early efficacy and safety |
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| Not yet recruiting | N/A | 25 | | Luspatercept 1.0mg/kg, injection every 21 days, two injections | West China Hospital, Sichuan University; West China Hospital Sichuan University, Beijing Life Oasis Public Welfare Service Center | myelofibrosis | | | | |
ChiCTR2400083226: A dose-exploration clinical study evaluating the combination of Ruxolitinib and luspatercept in the treatment of myelofibrotic anemia in subjects |
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| Recruiting | N/A | 18 | | Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.0mg/kg. The second titration reaches 1.33mg/kg, and the third titration reaches 1.75mg/kg; Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.33mg/kg. The second titration reaches 1.75mg/kg, and the third titration reaches 2.0mg/kg; Ruxolitinib maintains the original therapeutic dose,Luspatercept with a starting dose of 1.5mg/kg. The second titration reaches 2.0mg/kg, and the third titration reaches 2.5mg/kg | West China Hospital of Sichuan University; West China Hospital of Sichuan University, Beijing Life Oasis Public Welfare Service Center | myelofibrosis | | | | |
ChiCTR2400086837: A clinical study evaluating the efficacy and safety of luspatercept combined with androgen in the treatment of anemia caused by very poor, poor or intermediate risk IPSS-R myelodysplastic syndrome (MDS) |
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| Recruiting | N/A | 16 | | Accepting luspatercept combined with androgen | The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University, Guangzhou Life Oasis | very poor, poor or intermediate risk IPSS-R myelodysplastic syndrome | | | | |
NCT06073860: A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia |
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| Recruiting | N/A | 104 | RoW | Luspatercept | Bristol-Myers Squibb | Myelodysplastic Syndrome, Beta Thalassemia | 12/27 | 12/27 | | |
| Recruiting | N/A | 2300 | US | Luspatercept | Celgene | Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute | 03/31 | 03/31 | | |