60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| 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 | NCT05323617 (ClinicalTrials.gov) | May 15, 2023 | 5/4/2022 | Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy | Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Adult Severe Aplastic Anemia Participants Who Are Either Previously Untreated With IST or Refractory to IST | Severe Aplastic Anemia (SAA) | Drug: Romiplostim;Drug: Antithymocyte Globulin;Drug: Cyclosporine A | Amgen | NULL | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 2 | NULL |
| 2 | NCT05600426 (ClinicalTrials.gov) | January 25, 2023 | 20/10/2022 | A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | Severe Aplastic Anemia | Drug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoetic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: Methotrexate;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST) | Boston Children's Hospital | Center for International Blood and Marrow Transplant Research;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);North American Pediatric Aplastic Anemia Consortium;Pediatric Transplantation and Cellular Therapy Consortium;Blood and Marrow Transplant Clinical Trials Network | Recruiting | 0 Years | 25 Years | All | 234 | Phase 3 | United States |
| 3 | ChiCTR2200056659 | 2023-01-16 | 2022-02-10 | Allopurinol in the treatment of cyclosporine-induced hyperuricemia in children with aplastic anemia:a randomized controlled study | Allopurinol in the treatment of cyclosporine-induced hyperuricemia in children with aplastic anemia:a randomized controlled study | hyperuricemia | Allopurinol group:Receive allopurinol tablets;Placebo group:Receive placebo; | The Seventh Affiliated Hospital, Sun Yat-sen University | NULL | Pending | 1 | 18 | Both | Allopurinol group:20;Placebo group:20; | Phase 4 | China |
| 4 | NCT05660785 (ClinicalTrials.gov) | December 1, 2022 | 23/11/2022 | Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia | The Efficacy and Safety of Herombopag Combined With Cyclosporine for Patients With Non Severe Aplastic Anemia | Non Severe Aplastic Anemia;Untreated | Drug: Herombopag | Institute of Hematology & Blood Diseases Hospital | Jiangsu Hengrui Pharmaceuticals Co.,Ltd | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | China |
| 5 | NCT05399732 (ClinicalTrials.gov) | July 2022 | 24/5/2022 | Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia | A Randomized, Case Controlled Clinical Trial Evaluating the Efficiency and Safety of Luspatercept Plus Ciclosporin Versus Ciclosporin in Newly Diagnosed Transfusion Independent Non-severe Aplastic Anemia (NSAA). | Aplastic Anemia | Drug: Luspatercept | Bing Han | NULL | Not yet recruiting | 18 Years | 80 Years | All | 90 | Phase 2 | China |
| 6 | NCT05049668 (ClinicalTrials.gov) | October 2021 | 13/9/2021 | RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial | Long-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients | Severe Aplastic Anemia | Drug: ATGAM plus CsA with or without Eltrombopag | European Society for Blood and Marrow Transplantation | NULL | Enrolling by invitation | N/A | N/A | All | 197 | France | |
| 7 | ChiCTR2100050948 | 2021-09-10 | 2021-09-08 | Comparison of clinical efficacy and safety of hematopoietic stem cell transplantation and immunosuppression in the treatment of hepatitis-related aplastic anemia: a single-center cohort study | Comparison of clinical efficacy and safety of hematopoietic stem cell transplantation and immunosuppressive therapy in patients with hepatitis-related aplastic anemia | Hepatitis-associated Aplastic Anemia | ematopoietic stem cell transplantation group:Nil;ATG combined with cyclosporine group :Nil; | Zhejiang Provincial Hospital of Traditional Chinese Medicine | NULL | Recruiting | 1 | 50 | Both | ematopoietic stem cell transplantation group:30;ATG combined with cyclosporine group :30; | China | |
| 8 | ChiCTR2100043229 | 2021-02-22 | 2021-02-09 | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | Aplastic anemia | Durgs Group:Elrombopag combined with Cyclosporine; | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 85 | Both | Durgs Group:61; | Phase 2 | China |
| 9 | ChiCTR2000041485 | 2021-01-01 | 2020-12-27 | Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study | Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study | transfusion independent aplastic anemia | experimental group:Cyclosporine combined with danazol;control group:Cyclosporine; | Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College | NULL | Recruiting | Both | experimental group:152;control group:76; | Phase 4 | China | ||
| 10 | NCT04328727 (ClinicalTrials.gov) | November 4, 2020 | 9/3/2020 | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia | A Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS) | Severe Aplastic Anemia (SAA) | Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA) | Novartis Pharmaceuticals | NULL | Active, not recruiting | 6 Years | N/A | All | 36 | Phase 2 | China;Japan;Korea, Republic of;Taiwan |
| 11 | NCT05088174 (ClinicalTrials.gov) | September 3, 2020 | 12/10/2021 | A Trial of Hetrombopag in Healthy Subjects | A Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy Subjects | Sever Aplastic Anaemia | Drug: Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 65 Years | All | 26 | Phase 1 | China |
| 12 | NCT04304820 (ClinicalTrials.gov) | May 7, 2020 | 10/3/2020 | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Severe Aplastic Anemia | Drug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-Globulin | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 3 Years | N/A | All | 39 | Phase 2 | United States |
| 13 | NCT04095936 (ClinicalTrials.gov) | December 3, 2019 | 18/9/2019 | Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia | A Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive Therapy | Aplastic Anemia | Drug: Romiplostim | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 24 | Phase 2/Phase 3 | Japan |
| 14 | JPRN-JapicCTI-194962 | 03/12/2019 | 18/09/2019 | A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia | A Phase 2/3 Study of AMG531 Combined with Ciclosporin A in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy | Aplastic Anemia | Intervention name : AMG531 INN of the intervention : romiplostim Dosage And administration of the intervention : SC-administered Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd | NULL | complete | 20 | BOTH | 24 | Phase 2-3 | Japan, Asia except Japan | |
| 15 | JPRN-jRCTs071190032 | 26/11/2019 | 21/10/2019 | W-JHS AA02 | Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 | aplastic anemia | 1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased. 2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6. 3. The dose of steroid is as follows: Day 1 - day 5: methylprednisolone 2 mg/kg/day Day 6: Methylprednisolone 1 mg/kg/day Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day Discontinuation after day 21 4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study). | Ishiyama Ken | NULL | Recruiting | >= 18age old | < 80age old | Both | 60 | Phase 2 | Japan |
| 16 | NCT03896971 (ClinicalTrials.gov) | November 15, 2019 | 21/3/2019 | Combination of Thrombopoietin Mimetic and Immunosuppressive Therapy in Aplastic Anaemia | Treatment With Thrombopoietin Mimetic Plus Immunosuppressive Therapy in Egyptian Patients With Aplastic Anaemia | Aplastic Anemia | Drug: Combination of thrombopoietin mimetic and cyclosporin A | Safaa AA Khaled | Assiut University | Completed | 16 Years | 65 Years | All | 66 | Phase 4 | Egypt |
| 17 | EUCTR2016-002814-29-IT (EUCTR) | 14/06/2019 | 24/05/2021 | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral ] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE Product Name: Eltrombopag Product Code: [ETB115] INN or Proposed INN: 00319301 Other descriptive name: Eltrombopag Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India | ||
| 18 | NCT03218657 (ClinicalTrials.gov) | January 1, 2018 | 16/6/2017 | Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole | A Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole Hydrochloride | Aplastic Anemia | Drug: levamisole hydrochloride;Drug: Androgens;Drug: Cyclosporins | Shengyun Lin | NULL | Recruiting | 18 Years | 70 Years | All | 248 | N/A | China |
| 19 | NCT03243656 (ClinicalTrials.gov) | December 20, 2017 | 2/8/2017 | Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia | Randomized Clinical Trial of the Use of & Cyclosporine in Children With Sever Idiopathic Aplastic Anemia | Eltrombopag | Drug: Eltrombopag | Assiut University | NULL | Completed | 1 Year | 18 Years | All | 20 | Phase 4 | Egypt |
| 20 | JPRN-UMIN000030453 | 2017/12/20 | 18/12/2017 | Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia | Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia - Aplastic anemia 01 study in West Japan Hematology Study Group (W-JHS AA01 study) | aplastic anemia | 1.Start CsA (Neoral or generic drugs emulsified in the same way as Neoral) at a dose of 3.5 mg/kg, bid (before breakfast and before dinner). 2.Measure the blood concentration of cyclosporine at 2 hours (C2) after taking the drug and determine the minimum dose of cyclosporine that produces C2 >600 ng/mL. Continue the dose of cyclosporine for 8 weeks. 3.Continue the treatment for further 44 weeks (a total of 52 weeks) when patients meet the response criteria of HI-E or HI-P at the end of the 8 week treatment. Treatments after the 52 weeks are not specified. When patients do not meet the IWG response criteria 2006 at the end of 8 weeks, the treatment is terminated and treatments after 9 weeks are not specified. | Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu | NULL | Complete: follow-up continuing | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan |
| 21 | EUCTR2016-002814-29-HU (EUCTR) | 07/09/2017 | 05/07/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 22 | EUCTR2016-002814-29-NL (EUCTR) | 21/07/2017 | 29/03/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months. | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 23 | ChiCTR-IOR-17011653 | 2017-07-01 | 2017-06-14 | A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochloride | A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochloride | Aplastic anemia | SA group:none;LSA group:levamisole hydrochloride; | The First affiliated Hospital of Zhejiang Chinese Medical University | NULL | Pending | 18 | 70 | Both | SA group:124;LSA group:124; | China | |
| 24 | EUCTR2016-002814-29-ES (EUCTR) | 21/03/2017 | 16/12/2016 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of | ||
| 25 | NCT03413306 (ClinicalTrials.gov) | December 10, 2016 | 22/12/2017 | Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA | A Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic Anemia | Acquired Aplastic Anemia | Drug: Eltrombopag;Drug: IST (ATG + CsA) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | 2 Years | 18 Years | All | 100 | Phase 3 | Russian Federation |
| 26 | ChiCTR-IOR-16008738 | 2016-08-01 | 2016-06-28 | A single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemia | A single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemia | aplastic anemia | A:Cyclosporin;B:Cyclosporin and Stanozolol; | The First Affiliated Hospital of Zhengzhou University | NULL | Recruiting | 18 | 65 | Both | A:100;B:100; | China | |
| 27 | NCT02845596 (ClinicalTrials.gov) | August 2016 | 9/5/2016 | Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia | Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoietic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: methotrexate;Drug: fludarabine;Drug: cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST) | Michael Pulsipher, MD | NULL | Active, not recruiting | N/A | 25 Years | All | 40 | N/A | United States |
| 28 | EUCTR2014-000363-40-NL (EUCTR) | 07/01/2016 | 01/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Spain;Netherlands | ||
| 29 | NCT02745717 (ClinicalTrials.gov) | January 2016 | 7/4/2016 | The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia | The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Thymoglobulin;Procedure: Cord blood;Drug: Cyclosporine Oral Product | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Ruijin Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Shanghai Tongji Hospital, Tongji University School of Medicine;Zhejiang Provincial Hospital of TCM | Completed | N/A | 60 Years | All | 60 | Phase 4 | China |
| 30 | EUCTR2014-000363-40-ES (EUCTR) | 26/10/2015 | 07/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Spain | |||
| 31 | NCT02462252 (ClinicalTrials.gov) | October 2015 | 25/5/2015 | Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome | A Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS) | Aplastic Anemia;Hypoplastic Myelodysplastic Syndrome | Drug: BL-8040;Drug: horse anti-thymocyte globulin (hATG);Drug: Methylprednisolone;Drug: Cyclosporine | BioLineRx, Ltd. | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 32 | ChiCTR1900028153 | 2015-07-01 | 2019-12-13 | A Multi-centre Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic Anemia | A Multi-centrer Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic Anemia | Aplstic Anemia | Experimental group:Pai-Neng-Da Capsule + Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D);Control group:Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D); | Jinhua people's Hospital | NULL | Completed | Both | Experimental group:50;Control group:50; | Phase 2-3 | NULL | ||
| 33 | ITMCTR1900002832 | 2015-07-01 | 2019-12-13 | A Multi-centre Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic Anemia | A Multi-centrer Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic Anemia | Aplstic Anemia | Control group:Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D);Experimental group:Pai-Neng-Da Capsule + Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D); | Jinhua people's Hospital | NULL | Completed | Both | Control group:50;Experimental group:50; | NULL | |||
| 34 | NCT02099747 (ClinicalTrials.gov) | July 2015 | 6/3/2014 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients. | Severe Aplastic Anemia | Drug: hATG;Drug: CsA;Drug: Eltrombopag | European Group for Blood and Marrow Transplantation | Novartis;Pfizer | Active, not recruiting | 15 Years | N/A | All | 202 | Phase 3 | France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany |
| 35 | NCT02773225 (ClinicalTrials.gov) | January 27, 2015 | 29/2/2016 | Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA) | Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter Study | Anemia, Aplastic | Drug: Eltrombopag;Drug: Placebo (for Eltrombopag) | B. Höchsmann | NULL | Recruiting | 18 Years | N/A | All | 116 | Phase 2/Phase 3 | Germany |
| 36 | EUCTR2014-000174-19-DE (EUCTR) | 27/01/2015 | 01/09/2014 | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA | Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade 75 mg Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag Other descriptive name: ELTROMBOPAG OLAMINE | Universitätsklinikum Ulm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;Germany;Switzerland | ||
| 37 | NCT02203396 (ClinicalTrials.gov) | August 2014 | 27/7/2014 | A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia | A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia | Aplastic Anemia | Drug: rabbit ATG, Cyclosporine, Levamisole | Yizhou Zheng | NULL | Recruiting | 6 Years | 70 Years | Both | 40 | Phase 2 | China |
| 38 | NCT02028416 (ClinicalTrials.gov) | September 2013 | 2/1/2014 | Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia | Protocol for Comparison of Two Different Regimens of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia | Aplastic Anemia | Drug: ATG-fresenius | National Institute of Blood Disease Center, Pakistan | NULL | Recruiting | 2 Years | 65 Years | Both | 60 | N/A | Pakistan |
| 39 | NCT01760096 (ClinicalTrials.gov) | January 2013 | 1/1/2013 | Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013) | Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013) | Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, Hemolytic | Drug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: Glucocorticoids | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 50 | Phase 2 | China |
| 40 | NCT01659606 (ClinicalTrials.gov) | July 2012 | 6/8/2012 | Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita | Radiation- and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita / Telomere Disease | Dyskeratosis Congenita;Hoyeraal Hreidarsson Syndrome;Revesz Syndrome;Aplastic Anemia | Biological: alemtuzumab;Drug: Fludarabine;Drug: Cyclosporins;Drug: Mycophenolate mofetil;Drug: Tacrolimus | Boston Children's Hospital | Dana-Farber Cancer Institute;Children's Hospital Medical Center, Cincinnati;Children's Hospital Los Angeles;Fred Hutch/University of Washington/Seattle Children's Cancer Consortium;Baylor College of Medicine;Children's Hospital of Philadelphia;University of Wisconsin, Madison;Karolinska University Hospital;Hackensack Meridian Health;Duke University;Oslo University Hospital;Children's Mercy Hospital Kansas City;Mayo Clinic;University of Chicago;Massachusetts General Hospital | Active, not recruiting | 30 Days | 65 Years | All | 40 | Phase 2 | United States;Norway;Sweden |
| 41 | NCT01642979 (ClinicalTrials.gov) | July 2012 | 14/7/2012 | Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria | Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, Hemolytic | Drug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: Glucocorticoids | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 120 | Phase 2 | China |
| 42 | NCT01624805 (ClinicalTrials.gov) | June 25, 2012 | 19/6/2012 | Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome | Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS) | Aplastic Anemia;de Novo Myelodysplastic Syndrome;Myelodysplastic Syndrome;Previously Treated Myelodysplastic Syndrome | Biological: Anti-Thymocyte Globulin;Drug: Cyclosporine;Biological: Filgrastim;Drug: Methylprednisolone;Biological: Pegfilgrastim | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | Recruiting | N/A | N/A | All | 100 | Phase 2 | United States |
| 43 | NCT01193283 (ClinicalTrials.gov) | August 2010 | 31/8/2010 | Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia | Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia | Aplastic Anemia;Neutropenia;Pancytopenia;Severe Aplastic Anemia | Drug: Cyclophosphamide;Drug: Cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | N/A | All | 22 | Phase 1/Phase 2 | United States |
| 44 | EUCTR2007-000902-55-DE (EUCTR) | 17/12/2009 | 29/09/2009 | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party | Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 12.0;Level: LLT;Classification code 10002969;Term: Aplastic anemia | Trade Name: Thymoglobulin Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) | EBMT (European Group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 45 | NCT00987480 (ClinicalTrials.gov) | September 25, 2009 | 30/9/2009 | Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine | A Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine | Aplastic Anemia;Leukemia;Myelodysplastic Syndrome | Drug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS device | Memorial Sloan Kettering Cancer Center | Boston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research Center | Completed | N/A | N/A | All | 45 | Phase 2 | United States |
| 46 | NCT00944749 (ClinicalTrials.gov) | July 2009 | 22/7/2009 | Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment | Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment | Anemia, Aplastic;Anemia, Hypoplastic | Drug: h-ATG (ATGAM );Drug: Cyclosporine (Gengraf ) | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | 82 Years | All | 23 | Phase 2 | United States |
| 47 | EUCTR2009-012746-23-IT (EUCTR) | 12/05/2009 | 24/06/2009 | pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND | pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND | acquired aplastic anemia MedDRA version: 9.1;Level: SOC;Classification code 10005329 | Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML INN or Proposed INN: Etanercept | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 48 | NCT00471848 (ClinicalTrials.gov) | August 2008 | 9/5/2007 | Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia and Comparison With Matched Historical Patients Treated With Horse ATG and Ciclosporin | Aplastic Anemia | Drug: rabbit antithymocyte globulin | European Group for Blood and Marrow Transplantation | Genzyme, a Sanofi Company | Active, not recruiting | 16 Years | N/A | Both | 35 | Phase 2 | France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom |
| 49 | EUCTR2007-000902-55-FR (EUCTR) | 23/04/2008 | 04/10/2007 | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 9.1;Level: LLT;Classification code 10002274;Term: Anemia aplastic | Trade Name: Thymoglobuline Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) Other descriptive name: GLYCINE Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: Mannitol Trade Name: Neoral Product Name: Ciclosporine INN or Proposed INN: Cyclosporin A Other descriptive name: Ciclosporine | EBMT (European group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 50 | NCT01530555 (ClinicalTrials.gov) | April 2008 | 24/1/2012 | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Acquired Aplastic Anaemia | Drug: Rabbit ATG, Thymoglobuline (Genzyme) | King Faisal Specialist Hospital & Research Center | NULL | Completed | 16 Years | 80 Years | Both | 35 | Phase 2 | NULL |
| 51 | EUCTR2007-000902-55-GB (EUCTR) | 19/09/2007 | 26/06/2007 | Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 14.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: Thymoglobuline Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) INN or Proposed INN: GLYCINE INN or Proposed INN: Sodium chloride INN or Proposed INN: Mannitol | EBMT (European group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Germany;United Kingdom | ||
| 52 | EUCTR2006-006577-25-SE (EUCTR) | 25/07/2007 | 11/06/2007 | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders MedDRA version: 9.1;Level: LLT;Classification code 10018799;Term: GVHD | Trade Name: Rapamune Product Name: Rapamune INN or Proposed INN: SIROLIMUS Other descriptive name: Rapamycin Trade Name: Prograf Product Name: Prograf INN or Proposed INN: TACROLIMUS Other descriptive name: FK-506 Trade Name: Sandimmun Neoral Product Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Other descriptive name: CsA Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Finland;Sweden | |||
| 53 | EUCTR2008-001151-22-IT (EUCTR) | 06/06/2007 | 14/06/2011 | ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa | ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa | Aplastic anemia and single-lineage bone marrow failure MedDRA version: 13.1;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 13.1;Level: LLT;Classification code 10047350;Term: Very few granulocyte precursors;Classification code 10002967;Term: Aplastic anaemia;Classification code 10001507;Term: Agranulocytosis;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Italy | |||
| 54 | NCT00895739 (ClinicalTrials.gov) | June 2006 | 7/5/2009 | Alemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow Failure | Alemtuzumab and Low-Dose Cyclosporine-A as Alternative Immunosuppressive Treatment for Severe Aplastic Anemia (SAA) and Single-Lineage Aplastic Patients | Nonmalignant Neoplasm | Biological: alemtuzumab;Drug: cyclosporine | Federico II University | NULL | Recruiting | 18 Years | N/A | Both | 50 | Phase 2 | Italy |
| 55 | NCT00319878 (ClinicalTrials.gov) | May 2006 | 28/4/2006 | Sirolimus and Cyclosporine for Treatment-Resistant Aplastic Anemia | A Phase I/II Trial of Sirolimus (Rapamune) and Cyclosporine in Patients With Refractory Aplastic Anemia | Anemia, Aplastic | Drug: Sirolimus;Drug: Cyclosporine | Office of Rare Diseases (ORD) | Rare Diseases Clinical Research Network | Recruiting | 21 Years | N/A | Both | 52 | Phase 1/Phase 2 | United States |
| 56 | NCT00343785 (ClinicalTrials.gov) | February 2006 | 22/6/2006 | Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant | Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial | Aplastic Anemia | Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: allogeneic bone marrow transplantation;Drug: methotrexate;Genetic: DNA analysis;Other: flow cytometry;Genetic: polymorphism analysis;Other: laboratory biomarker analysis | Fred Hutchinson Cancer Research Center | National Heart, Lung, and Blood Institute (NHLBI) | Completed | N/A | 65 Years | All | 21 | Phase 2 | United States;Canada |
| 57 | NCT00354419 (ClinicalTrials.gov) | February 2006 | 19/7/2006 | Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant | A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood | Aplastic Anemia | Radiation: total-body irradiation;Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: umbilical cord blood transplantation;Drug: mycophenolate mofetil;Procedure: bone marrow aspiration;Genetic: DNA analysis;Biological: filgrastim | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Terminated | N/A | 40 Years | Both | 30 | Phase 1 | United States |
| 58 | NCT00260689 (ClinicalTrials.gov) | November 28, 2005 | 1/12/2005 | Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia | A Randomized Study of Three Immunosuppressive Regimens in Treatment Naive Patients With Severe Aplastic Anemia: Horse ATG/CsA Taper vs Rabbit-ATG/CsA vs Alemtuzumab | Immunosuppresion;Thrombocytopenia;Pancytopenia;Neutropenia | Biological: Anti-thymocyte globulin (rabbit);Biological: Anti-thymocyte globulin (horse);Drug: Cyclosporine;Drug: Alemtuzumab | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | N/A | All | 136 | Phase 2 | United States |
| 59 | NCT00195624 (ClinicalTrials.gov) | September 15, 2005 | 16/9/2005 | Alemtuzumab to Treat Severe Aplastic Anemia | A Pilot Study of Alemtuzumab (Campath) in Patients With Relapsed or Refractory Severe Aplastic Anemia | Severe Aplastic Anemia, Refractory;Severe Aplastic Anemia, Relapse | Biological: Alemtuzumab (Campath );Drug: Cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | 110 Years | All | 47 | Phase 2 | United States |
| 60 | NCT00806598 (ClinicalTrials.gov) | May 2005 | 9/12/2008 | Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome | Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome | Myelodysplastic Syndrome;Aplastic Anemia | Drug: Thymoglobulin;Drug: Cyclosporine;Drug: Methylprednisolone;Drug: G-CSF | M.D. Anderson Cancer Center | Genzyme, a Sanofi Company | Completed | 15 Years | N/A | All | 53 | Phase 2 | United States |
| 61 | NCT01231841 (ClinicalTrials.gov) | March 2005 | 29/10/2010 | Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia | Protocol for Prospective Phase II Study of Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) as a First Line Immunosuppressive (IS) Therapy for Severe Aplastic Anemia (sAA) | Aplastic Anemia | Drug: cyclosporine;Biological: anti-thymocyte globulin | The Cleveland Clinic | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | United States |
| 62 | NCT00061360 (ClinicalTrials.gov) | June 26, 2003 | 23/5/2003 | Improving Immunosuppressive Treatment for Patients With Severe Aplastic Anemia | A Randomized Trial of a Novel Immunosuppressive Combination of ATG, CsA and Sirolimus (Rapamune) vs a Slow Taper Cyclosporine Regimen in Subjects With Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: ATG+Rapamune+cyclosporine;Drug: ATG+cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | 110 Years | All | 77 | Phase 2 | United States |
| 63 | NCT00533923 (ClinicalTrials.gov) | December 2002 | 20/9/2007 | Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders | Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders | AML;ALL;CLL;Myelodysplastic Syndrome;Non-Hodgkin's Lymphoma;Hodgkin's Lymphoma;Multiple Myeloma;Aplastic Anemia;Myeloproliferative Disorder | Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF | Beth Israel Deaconess Medical Center | Bayer | Completed | N/A | 65 Years | Both | 25 | Phase 2 | United States |
| 64 | NCT00017654 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia | Graft Versus Host Disease;Aplastic Anemia | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: Allogeneic Bone Marrow Transplantation | Northwestern Memorial Hospital | NULL | Active, not recruiting | 15 Years | 55 Years | Both | 3 | N/A | United States | |
| 65 | NCT01163942 (ClinicalTrials.gov) | March 2001 | 14/7/2010 | Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF) | A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF | Aplastic Anaemia | Drug: G-CSF;Drug: Early retreatment with ATG | European Group for Blood and Marrow Transplantation | CHUGAI sanofi-aventis | Terminated | N/A | N/A | Both | 205 | Phase 3 | Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom |
| 66 | NCT00005935 (ClinicalTrials.gov) | June 2000 | 6/7/2000 | Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia | A Randomized Trial for the Treatment of Relapsing Aplastic Anemia With Mycophenolate Mofetil (MMF) and Cyclosporine (CSA) | Aplastic Anemia | Drug: Mycophenolate mofetil;Drug: Cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 130 | Phase 2 | United States |
| 67 | NCT00001964 (ClinicalTrials.gov) | March 17, 2000 | 18/1/2000 | Combination Therapy of Severe Aplastic Anemia | Treatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF) | Severe Aplastic Anemia | Drug: Cyclosporine A;Drug: ATG;Drug: MMF | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 1 Year | 99 Years | All | 104 | Phase 2 | United States |
| 68 | NCT00636909 (ClinicalTrials.gov) | July 1999 | 10/3/2008 | Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders | Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders | AML;ALL;CML Chronic Phase, Accelerated Phase, or Blast Crisis;CLL;MDS;RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA;APLASTIC ANEMIA;MULTIPLE MYELOMA;MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET) | Drug: Cyclophosphamide;Drug: fludarabine;Drug: cyclosporine;Drug: methotrexate;Biological: G-CSF | Beth Israel Deaconess Medical Center | Amgen | Completed | N/A | 65 Years | All | 25 | Phase 2 | NULL |
| 69 | NCT00001626 (ClinicalTrials.gov) | June 2, 1997 | 3/11/1999 | Comparing Therapies for the Treatment of Severe Aplastic Anemia | A Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic Anemia | Severe Aplastic Anemia (SAA) | Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 15 Years | 110 Years | All | 33 | Phase 2 | United States |
| 70 | NCT00005852 (ClinicalTrials.gov) | June 1996 | 2/6/2000 | Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant | Allogeneic Bone Marrow Transplantation for Marrow Failure States | Chronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes | Biological: anti-thymocyte globulin;Biological: filgrastim;Biological: muromonab-CD3;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: allogeneic bone marrow transplantation | H. Lee Moffitt Cancer Center and Research Institute | National Cancer Institute (NCI) | Terminated | 15 Years | 55 Years | Both | Phase 2 | NULL | |
| 71 | NCT00004323 (ClinicalTrials.gov) | February 1995 | 18/10/1999 | Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia | Aplastic Anemia | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: mesna;Drug: methotrexate;Drug: methylprednisolone | National Center for Research Resources (NCRR) | University of California, Los Angeles | Completed | N/A | 55 Years | Both | 10 | Phase 2 | United States |