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Clinical trials for GM-CSF

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    107 result(s) found for: GM-CSF. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2006-004674-27 Sponsor Protocol Number: 14076 Start Date*: 2007-02-14
    Sponsor Name:Dutch Kidney Foundation
    Full Title: Effect of GM-CSF on development of antigen-specific T cell responses following hepatitis B vaccination
    Medical condition: Haemodialysis patients are susceptible for infections due to a continuous mildly activated immune system. About 40% of the haemodialysis patients does not respond to the standard HBV vaccination pr...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10018487 GM-CSF prophylaxis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006140-20 Sponsor Protocol Number: 005/05 Start Date*: 2009-06-01
    Sponsor Name:BioVex Inc
    Full Title: A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEX GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients with Unresectable Stage ...
    Medical condition: Unresectable Stage IIIb, IIIc and IV Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-021070-11 Sponsor Protocol Number: 005/05E Start Date*: 2010-11-23
    Sponsor Name:BioVex Inc
    Full Title: An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEX GM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05
    Medical condition: Unresectable Stage IIIb, IIIc and IV Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-003841-17 Sponsor Protocol Number: OncoVEX GM-CSF/002/03 Start Date*: 2007-02-13
    Sponsor Name:BioVex Inc
    Full Title: A PHASE II STUDY OF THE EFFICACY, SAFETY AND IMMUNOGENICITY OF ONCOVEX GM CSF IN PATIENTS WITH STAGE IIIc AND STAGE IV MALIGNANT MELANOMA
    Medical condition: Stage IIIc and stage IV malignant melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-000609-10 Sponsor Protocol Number: 2020-01-GMF-1 Start Date*: 2021-07-06
    Sponsor Name:Center for Surgical Science
    Full Title: A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery A clinical safety and proof-of-con...
    Medical condition: A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001829-40 Sponsor Protocol Number: 201 Start Date*: 2019-01-02
    Sponsor Name:Y-mAbs Therapeutics A/S
    Full Title: A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete...
    Medical condition: Treatment of high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066595 Neuroblastoma recurrent PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000934-38 Sponsor Protocol Number: CP-BR-1-2007 Start Date*: 2007-10-30
    Sponsor Name:Generex Biotechnology Corporation
    Full Title: Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vacci...
    Medical condition: Disease-free, conventionally treated node-positive and high-risk node-negative breast cancer patients who are at significant risk for recurrence.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006187 Breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005815-10 Sponsor Protocol Number: AJSEB001 Start Date*: 2012-05-31
    Sponsor Name:Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Full Title: Developmental Clinical Sciences: Does GM-CSF restore effective neutrophil function in critically ill patients?
    Medical condition: Complement mediated dysfunctional neutrophil phagocytosis in critical illness.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10061314 Neutrophil function disorder PT
    16.1 10005329 - Blood and lymphatic system disorders 10017500 Functional disorders of polymorphonuclear neutrophils LLT
    14.1 10022891 - Investigations 10061867 Neutrophil function test abnormal PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-000213-30 Sponsor Protocol Number: IMA901-203 Start Date*: 2008-04-21
    Sponsor Name:immatics biotechnologies GmbH
    Full Title: Extension study to evaluate long-term-safety of IMA901 plus GM-CSF in advanced renal cell carcinoma patients who achieved a decrease in tumor load or stabilization of their disease after participat...
    Medical condition: This extension study will be conducted in men and women with advanced renal cell cancer (RCC) who achieved a decrease in tumor load or stabilization of their disease after participation in the core...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007086-23 Sponsor Protocol Number: FARM7MCPK4 Start Date*: 2008-12-12
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis.
    Medical condition: Autoimmune PAP
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037316 Pulmonary alveolar proteinosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-003925-17 Sponsor Protocol Number: HCC-PBMC-GM-CSF Start Date*: 2008-10-20
    Sponsor Name:AZIENDA OSPEDALIERA DI PARMA
    Full Title: Immunotherapy by autologous peripheral blood mononuclear cells and GM-CSF for hepatocellular carcinoma undergoing radiofrequency thermal ablation
    Medical condition: patients with hepatocellular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059319 Hepatic cancer stage II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001654-21 Sponsor Protocol Number: KKS-279 Start Date*: 2020-09-16
    Sponsor Name:Justus-Liebig-University Gießen
    Full Title: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia
    Medical condition: COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    23.1 10021881 - Infections and infestations 10084380 COVID-19 pneumonia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006068-32 Sponsor Protocol Number: CDX110-04 Start Date*: 2012-07-04
    Sponsor Name:Celldex Therapeutics, Inc
    Full Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma ...
    Medical condition: Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) GR (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) BE (Completed) ES (Prematurely Ended) NL (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004864-69 Sponsor Protocol Number: HSJD-HR-NB-Ch14.18 Start Date*: 2014-05-21
    Sponsor Name:Fundació Sant Joan de Deu de Barcelona
    Full Title: Phase II single arm institutional study to assess Dinutuximab combined with the cytokines granulocyte-macrophage colony stimulating factor (GM-CSF) and IL-2 in patients with high-risk neuroblastoma...
    Medical condition: High-risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-009919-21 Sponsor Protocol Number: IDI-ONC-4-20081216 Start Date*: 2009-09-21
    Sponsor Name:ISTITUTO DERMOPATICO IMMACOLATA
    Full Title: Antiangiogenic activity of metronomic therapy with capecitabine in metastatic solid tumors of gastrointestinal tract: a phase II study
    Medical condition: Metastatic solid tumors of gastrointestinal tract
    Disease: Version SOC Term Classification Code Term Level
    12.1 10025680 Malignant miscellaneous gastrointestinal neoplasms HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006370-25 Sponsor Protocol Number: IMA901-202 Start Date*: 2007-05-07
    Sponsor Name:immatics biotechnologies GmbH
    Full Title: Phase 2, randomised, open label, multicenter study of intradermal IMA901 plus GM-CSF with or without low dose cyclophosphamide pre-treatment in advanced renal cell carcinoma patients with measurabl...
    Medical condition: HLA-A*02-positive patients with advanced clear cell RCC who have progressed during or after first-line systemic therapy for advanced disease and have a favourable or intermediate risk after systemi...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) GB (Completed) AT (Completed) HU (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-007056-33 Sponsor Protocol Number: FL2008 RCHOPGM Start Date*: 2008-09-19
    Sponsor Name:Goelams
    Full Title: An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with RCHOP chemotherapy and Rituximab (MabThera®) ...
    Medical condition: This study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) and chemotherapy (CHOP) in patients with non bulky follicular non Hodgkin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025310 Lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019071-29 Sponsor Protocol Number: 006/09 Start Date*: 2010-07-26
    Sponsor Name:BioVex, Inc.
    Full Title: A Phase 3 Randomized Trial of Concurrent Cisplatin And Radiotherapy With or Without OncoVEXGM-CSF in Previously Untreated Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    Medical condition: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    Disease: Version SOC Term Classification Code Term Level
    12.1 10041823 Squamous cell carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005580-95 Sponsor Protocol Number: FL2008 RGM Start Date*: 2008-09-19
    Sponsor Name:Goelams
    Full Title: An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) in patients with follic...
    Medical condition: This study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) in patients with non bulky follicular non Hodgkin’s lymphoma with no prio...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025310 Lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000591-42 Sponsor Protocol Number: JX594-IV-HEP021 Start Date*: 2012-09-21
    Sponsor Name:Jennerex, Inc
    Full Title: A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advance...
    Medical condition: Advanced Hepatocellular Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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