Sargramostim (DrugBank: Sargramostim)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 2 |
| 28 | 全身性アミロイドーシス | 1 |
| 60 | 再生不良性貧血 | 2 |
| 62 | 発作性夜間ヘモグロビン尿症 | 1 |
| 96 | クローン病 | 7 |
| 229 | 肺胞蛋白症（自己免疫性又は先天性） | 6 |
| 285 | ファンコニ貧血 | 1 |
| 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 | NCT03790670 (ClinicalTrials.gov) | January 30, 2019 | 18/12/2018 | Biomarker Assessments of Leukine During Treatment of Parkinson's Disease | Safety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot Study | Parkinson Disease | Drug: sargramostim | University of Nebraska | NULL | Recruiting | 35 Years | 85 Years | All | 10 | Phase 1 | United States |
| 2 | NCT01882010 (ClinicalTrials.gov) | September 2013 | 13/6/2013 | Leukine (Sargramostim) for Parkinson's Disease | Leukine (Sargramostim) for Parkinson's Disease | Parkinson's Disease | Procedure: blood draw;Procedure: physical exam and UPDRS part III assessment;Procedure: MEG;Drug: sargramostim;Drug: placebo;Behavioral: physical exam and UPDRS part III assessment;Procedure: Motion Analysis | Howard Gendelman, MD | Sanofi;National Institute of Neurological Disorders and Stroke (NINDS);UNeMed;Nebraska Neuroscience Alliance | Completed | 35 Years | 85 Years | Both | 37 | Phase 1 | United States |
| 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 | NCT00007995 (ClinicalTrials.gov) | July 1999 | 6/1/2001 | Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis | Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Herbert Irving Comprehensive Cancer Center | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 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 | NCT00053157 (ClinicalTrials.gov) | June 2002 | 27/1/2003 | Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia | Use Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study | Chronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Neoplasms | Biological: sargramostim | Roswell Park Cancer Institute | National Cancer Institute (NCI) | Completed | 5 Years | 60 Years | Both | 10 | N/A | United States |
| 2 | NCT00053989 (ClinicalTrials.gov) | January 29, 2002 | 5/2/2003 | NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders | Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic Anemia | Biological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantation | Roswell Park Cancer Institute | NULL | Completed | 4 Years | 75 Years | All | 41 | Phase 2 | United States |
| 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 | NCT00012376 (ClinicalTrials.gov) | March 2001 | 3/3/2001 | Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer | Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies | Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Blastic Phase Chronic Myelogenous Leukemia;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Paroxysmal Nocturnal Hemoglobinuria;Previously Treated Myelodysplastic Syndromes;Recurrent Adult Acute Myeloid Leukemia;Refractory Anemia;Refractory Anemia With Ringed Sideroblasts;Relapsing Chronic Myelogenous Leukemia;Thrombocytopenia;Untreated Adult Acute Myeloid Leukemia | Drug: bryostatin 1;Biological: sargramostim;Other: laboratory biomarker analysis;Other: pharmacological study | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | Both | 35 | Phase 1 | United States |
| 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 | NCT00329537 (ClinicalTrials.gov) | June 2006 | 23/5/2006 | Study of Sargramostim in Moderately to Severely Active Crohn's Disease | Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study) | Crohn's Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 11 | Phase 2 | Japan |
| 2 | NCT00295165 (ClinicalTrials.gov) | January 2006 | 21/2/2006 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 33 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine |
| 3 | NCT00206661 (ClinicalTrials.gov) | December 2004 | 12/9/2005 | Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease | Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | NULL | Terminated | 6 Years | 16 Years | Both | 22 | Phase 1;Phase 2 | United States |
| 4 | NCT00206674 (ClinicalTrials.gov) | September 2004 | 13/9/2005 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 286 | Phase 3 | Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 5 | NCT00206713 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim | Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 264 | Phase 3 | United States |
| 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 |
| 6 | NCT00206596 (ClinicalTrials.gov) | July 2003 | 12/9/2005 | Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease | Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 80 Years | Both | 127 | Phase 2 | United States;Canada |
| 7 | NCT00206700 (ClinicalTrials.gov) | February 2003 | 13/9/2005 | Open-label Trial of Leukine in Active Crohn's Disease | Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 378 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 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 | NCT03006146 (ClinicalTrials.gov) | July 13, 2017 | 28/11/2016 | Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis | Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis | Autoimmune Pulmonary Alveolar Proteinosis | Drug: Sargramostim | Children's Hospital Medical Center, Cincinnati | Rare Diseases Clinical Research Network;National Center for Advancing Translational Science (NCATS) | Recruiting | 18 Years | 80 Years | All | 10 | Phase 1 | United States |
| 2 | NCT02835742 (ClinicalTrials.gov) | September 1, 2016 | 13/7/2016 | Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan | Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan | Pulmonary Alveolar Proteinosis, Autoimmune | Drug: Sargramostim;Drug: Placebo | Niigata University Medical & Dental Hospital | NULL | Completed | 16 Years | 80 Years | All | 78 | Phase 2 | Japan |
| 3 | NCT02840708 (ClinicalTrials.gov) | May 2016 | 13/7/2016 | SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study | SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study | Pulmonary Alveolar Proteinosis, Autoimmune | Drug: Sargramostim | Niigata University Medical & Dental Hospital | NULL | Completed | 20 Years | 80 Years | All | 14 | Phase 1 | Japan |
| 4 | NCT00901511 (ClinicalTrials.gov) | July 2009 | 11/5/2009 | Whole Lung Lavage (WLL)/Inhaled Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (PAP) | Whole Lung Lavage Followed by Inhaled Sargramostim in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis | Pulmonary Alveolar Proteinosis | Drug: GM-CSF [Leukine (Sargramostim)];Procedure: WLL | IRCCS Policlinico S. Matteo | Agenzia Italiana del Farmaco | Enrolling by invitation | 18 Years | N/A | Both | 18 | Phase 2;Phase 3 | Italy |
| 5 | EUCTR2008-007086-23-IT (EUCTR) | 12/12/2008 | 27/01/2009 | Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP | Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP | Autoimmune PAP MedDRA version: 9.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis | Trade Name: Leukine INN or Proposed INN: Sargramostim | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 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 |
| 6 | NCT00030056 (ClinicalTrials.gov) | September 2001 | 30/1/2002 | GM-CSF in Patients With Pulmonary Alveolar Proteinosis | Trial of GM-CSF for Alveolar Proteinosis | Pulmonary Alveolar Proteinosis | Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim) | The Cleveland Clinic | NULL | Terminated | 18 Years | 70 Years | Both | 48 | Phase 2 | United States |
| 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 | NCT00053989 (ClinicalTrials.gov) | January 29, 2002 | 5/2/2003 | NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders | Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic Anemia | Biological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantation | Roswell Park Cancer Institute | NULL | Completed | 4 Years | 75 Years | All | 41 | Phase 2 | United States |