Clinical trials: sargramostim
Autoimmune Pulmonary Alveolar Proteinosis
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18.
- Trial name
- NCT06431776
- Testing
- Molgramostim
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Savara Inc.
Advanced Cancer, Advanced Malignancies
Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
- Trial name
- NCT02383212
- Testing
- Cemiplimab, Hypofractionated radiotherapy, Cyclophosphamide
- Where
- 47 sites in United States, Australia and 1 more
- Volunteers
- 398 people
- Sponsor
- Regeneron Pharmaceuticals
COVID-19
Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
- Trial name
- NCT04690387
- Testing
- AV-COVID-19, GM-CSF
- Where
- Indonesia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Aivita Biomedical, Inc.
Advanced Ovarian Cancer
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian…
- Trial name
- Cornerstone4 (NCT05794659)
- Testing
- AST-201, Paclitaxel, Carboplatin
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Aston Sci. Inc.
Non-Hodgkin's Lymphoma
Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease.
- Trial name
- NCT00510471
- Testing
- autologous immunoglobulin idiotype-KLH conjugate vaccine
- Where
- 9 sites in United States
- Sponsor
- Genitope Corporation
Crohn's Disease
Study of Sargramostim in Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro…
- Trial name
- NCT00329537
- Testing
- Sargramostim (Leukine)
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Dementia Alzheimer's Type
Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Primary Objective: To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC) on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to Alzheimer's disease…
- Trial name
- NCT02667496
- Testing
- Sargramostim GZ402664, Florbetapir F18
- Where
- United States
- Sponsor
- Sanofi
Triple-Negative Breast Cancer
A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).
- Trial name
- NCT04584112
- Testing
- Tiragolumab, Atezolizumab, Nab-paclitaxel
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 83 people
- Sponsor
- Hoffmann-La Roche
Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma
Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas
This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC.
- Conditions
- Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Trial name
- NCT02033616
- Testing
- AVOVA-1, MC
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Aivita Biomedical, Inc.
Colorectal Carcinoma
IMA910 Plus GM-CSF With Low-dose Cyclophosphamide Pre-treatment in Advanced Colorectal Carcinoma Patients Following a Successful 12 Week First-line Treatment With Oxaliplatin-based Chemotherapy (IMA910-101)
This study is being conducted in order determine whether IMA910 as single agent with GM-CSF as adjuvant following pre-treatment with low-dose cyclophosphamide is safe and shows sufficient anti-tumour effectiveness in patients…
- Trial name
- IMA910-101 (NCT00785122)
- Testing
- Endoxana, Leukine, IMA910, Endoxana, Leukine, IMA910, Aldara
- Where
- 41 sites in Belgium, Bulgaria and 7 more
- Volunteers
- 92 people
- Sponsor
- Immatics Biotechnologies GmbH
Lymphoma
GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00324831
- Testing
- autologous immunoglobulin idiotype-KLH conjugate vaccine, cyclophosphamide, doxorubicin hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 480 people
- Sponsor
- Favrille
Infertility
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
- Trial name
- GM-CSF (NCT00565747)
- Testing
- Test culture, Control culture
- Where
- 14 sites in Denmark, Sweden
- Volunteers
- 1,332 people
- Sponsor
- Origio A/S
Primary Refractory Neuroblastoma
A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF.
- Trial name
- NCT00969722
- Testing
- MAb-3F8, Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), 13-cis-Retinoic Acid
- Where
- 15 sites in United States
- Volunteers
- 1 people
- Sponsor
- United Therapeutics
Cytomegalovirus Retinitis, HIV Infections
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute…
- Trial name
- NCT00002070
- Testing
- Sargramostim, Ganciclovir
- Where
- 14 sites in United States
- Sponsor
- Schering-Plough
Breast Cancer
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus…
- Trial name
- NCT01570036
- Testing
- Herceptin, NeuVax vaccine, GM-CSF
- Where
- 29 sites in United States
- Volunteers
- 275 people
- Sponsor
- George E. Peoples
Venous Leg Ulcer
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.
- Trial name
- NCT04823962
- Testing
- rhGM-CSF + hydrogel, Standard care
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Reponex Pharmaceuticals A/S
Autoimmune Pulmonary Alveolar Proteinosis
Molgramostim Nebulizer Solution Expanded Access Program Protocol
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disorder in which a material called surfactant builds up in the lungs and makes it hard to breathe.
- Trial name
- NCT06546098
- Testing
- Molgramostim nebulizer solution
- Where
- 12 sites in United States
- Sponsor
- Savara Inc.
Breast Cancer
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone.
- Trial name
- HER3+ (NCT02297698)
- Testing
- NeuVax vaccine, Trastuzumab, GM-CSF
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cancer Insight, LLC
Autoimmune Pulmonary Alveolar Proteinosis
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
SAV006-03 is an open-label extension study for participants who had completed the IMPALA study. At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human…
- Trial name
- IMPALA-X (NCT03482752)
- Testing
- Molgramostim
- Where
- 13 sites in Denmark, France and 8 more
- Volunteers
- 60 people
- Sponsor
- Savara Inc.
Crohn Disease
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
- Trial name
- NCT00295165
- Testing
- Sargramostim (Leukine)
- Where
- 111 sites in United States, Australia and 9 more
- Volunteers
- 33 people
- Sponsor
- Genzyme, a Sanofi Company