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Leukine Medical Research Studies

Up-to-date List of Leukine Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Leukine Medical Research Studies

Rank Status Study
1 Unknown  A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis
Condition: Myasthenia Gravis
Intervention: Drug: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Outcome Measures: Safety of GM-CSF in patients with myasthenia gravis;   The change from baseline in the quantitative and functional (suppressive capacity) characterization of circulating regulatory T cells at 30 days post-treatment;   The change from baseline in the quantitative and functional (suppressive capacity) characterization of circulating regulatory T cells at 60 days post-treatment;   The change from baseline in the quantitative and functional (suppressive capacity) characterization of circulating regulatory T cells at 120 days post-treatment;   Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at 60 days;   Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 120;   Change from baseline in the Myasthenia Gravis Composite score at day 60;   Change from baseline in the Myasthenia Gravis Composite score at day 120;   Change from baseline in Manual Muscle Testing (MMT) score at day 60;   Change from baseline in Manual Muscle Testing (MMT) score at day 120;   Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at day 60;   Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at day 120;   Change from baseline in Quality of Life Assessment (SF-36) at day 60;   Change from baseline in Quality of Life Assessment (SF-36) at day 120;   Change from baseline in acetylcholine receptor antibody titre level at day 60;   Change from baseline in acetylcholine receptor antibody titre level at day 120;   Change from baseline in prednisone dose at day 60;   Change from baseline in prednisone dose at day 120 Days
2 Recruiting Study of the Safety & Efficacy of Granulocyte-Macrophage Colony-Simulating Factor (Leukine) in the Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
Interventions: Drug: Sagramostim;   Drug: Saline -- placebo comparator
Outcome Measures: Ability of Alzheimer's Disease subjects to tolerate Leukine treatment will be assessed;   Ability of Leukine treatment to improve cognition of Alzheimer's Disease subjects
3 Recruiting Leukine (Sargramostim) for Parkinson's Disease
Condition: Parkinson's Disease
Interventions: Procedure: blood draw;   Procedure: physical exam and UPDRS part III assessment;   Procedure: MEG;   Drug: sargramostim;   Drug: placebo
Outcome Measures: Number of adverse events;   Change in UPDRS part III score;   Change in blood analyses results;   Abnormal findings in physical examination;   Change in FACS results;   Change in function of Treg cells;   Change in magnetoencephalography results
4 Recruiting Does GM-CSF Restore Neutrophil Phagocytosis in Critical Illness?
Conditions: Critical Illness;   Sepsis;   Immuno-suppression
Interventions: Drug: Leukine;   Drug: Normal Saline
Outcome Measures: Neutrophil phagocytosis;   neutrophil phagocytic capacity on alternate study days;   Other measures of neutrophil function;   Monocyte HLA-DR expression;   Serum measures of inflammatory response;   Sequential organ failure assessment (SOFA);   Length of ICU stay;   Incidence of ICUAIs (Intensive care unit acquired infection);   All cause mortality;   Number of days of mechanical ventilation;   Blood sample analysis
5 Recruiting Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma
Condition: Neuroblastoma
Intervention: Biological: Hu3F8 With GM-CSF
Outcome Measures: maximum tolerated dosage;   assess the toxicity;   pharmacokinetics of hu3F8;   assess activity of hu3F8 plus GM-CSF against NB;   quantitate the response of marrow NB
6 Recruiting Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD)
Condition: Peripheral Arterial Disease
Interventions: Behavioral: Supervised Treadmill Exercise Therapy;   Other: Health education sessions (Control);   Drug: granulocyte macrophage colony stimulating factor (GM-CSF)
Outcome Measures: Change in Six-Minute Walk Performance at 12-week follow-up;   Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week follow-up;   Change in Maximal treadmill walking time at 12-week follow-up;   Change in CD34+ cells at 12-week follow-up
7 Recruiting ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
Conditions: Glioblastoma;   Gliosarcoma
Interventions: Drug: ERC1671;   Drug: GM-CSF;   Drug: Cyclophosphamide;   Drug: Oral Control (Sucrose pill);   Drug: Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%));   Drug: Bevacizumab
Outcome Measures: Safety;   Efficacy;   Immune Response
8 Recruiting Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Condition: HER2 Low to Intermediate Breast Cancer
Interventions: Biological: NeuVax™ vaccine;   Biological: Leukine® (sargramostim, GM-CSF) and water for injection
Outcome Measures: Comparison of DFS in vaccine treated patients and control patients;   Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety
9 Recruiting GM-CSF for Immunomodulation Following Trauma (GIFT) Study
Condition: Critical Injury (Trauma) in Children
Interventions: Drug: GM-CSF;   Drug: placebo
Outcome Measures: Nosocomial infection;   Innate immune function;   Innate Immune Function
10 Recruiting Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
Conditions: Stage IB Melanoma;   Stage IIA Melanoma;   Stage IIB Melanoma;   Stage IIC Melanoma
Interventions: Biological: sargramostim;   Procedure: sentinel lymph node biopsy;   Other: laboratory biomarker analysis;   Other: hypertonic saline
Outcome Measures: Reversal of alterations in the SN;   Proportion of subjects with positive SN in each group;   Disease free survival (DFS);   Overall survival (OS)
11 Not yet recruiting Ipilimumab and GMCSF Immunotherapy for Prostate Cancer
Condition: Prostate Cancer
Interventions: Drug: Ipilimumab;   Drug: GM-CSF
Outcome Measures: To assess for clinical activity by PSA response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.;   To evaluate the duration of PSA response and time to PSA progression. To quantify the frequency of immune toxicities. To evaluate T cell activation. To assess for clinical activity by objective response.
12 Not yet recruiting Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
Conditions: Stage IV Melanoma;   Stage III Melanoma
Interventions: Biological: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC);   Biological: Autologous PBMCs in GM-CSF (MC)
Outcome Measures: Overall survival;   Adverse Events as a Measure of Safety and Tolerability
13 Recruiting The Treatment With HBIG+GM-CSF+HBV Vaccine for Chronic Hepatitis B Patients With HBeAg Seroconversion
Condition: Chronic Hepatitis B
Interventions: Drug: Drug;   Drug: GM-CSF control
Outcome Measures: the rate of hepatitis B surface antigen (HBsAg) seroconversion;   The rates of serum hepatitis B surface antigen (HBsAg) negative;   the decreased levels of serum hepatitis B surface antigen (HBsAg);   Number of participants with adverse events as a measure of safety and tolerability;   The frequency of hepatitis B virus (HBV)-specific T cells;   The frequency of hepatitis B virus (HBV)-specific B cells;   liver hepatitis B surface antigen (HBsAg) levels
14 Recruiting Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer
Conditions: HER2-positive Breast Cancer;   Male Breast Cancer;   Recurrent Breast Cancer;   Stage II Breast Cancer;   Stage IIIA Breast Cancer;   Stage IIIB Breast Cancer;   Stage IIIC Breast Cancer;   Stage IV Breast Cancer
Interventions: Biological: HER-2/neu peptide vaccine;   Biological: sargramostim;   Drug: rintatolimod;   Other: laboratory biomarker analysis
Outcome Measures: Evaluation of immune response among the different treatment arms in Stage I and II;   Evaluation of safety and systemic toxicity among the different treatment arms in Stage I and II;   Disease-free survival;   Overall survival
15 Recruiting A Phase II Study of 5-Azacitidine and Sargramostim as Maintenance Treatment After Definitive Therapy for Poor-risk AML or MDS
Conditions: Acute Myeloid Leukemia;   Myelodysplastic Syndrome
Intervention: Drug: 5-azacitidine and sargramostim
Outcome Measures: To evaluate the 2 year relapse free survival of patients;   1. Describe and quantify the toxicity profile of the combination of 5AC and GM-CSF;   2. Determine the impact on one-year RFS and overall survival for poor-risk myeloid disorders following maintenance therapy with 5AC and GM-CSF
16 Recruiting Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma
Condition: Neuroblastoma
Interventions: Biological: Anti-GD2 3F8 Monoclonal Antibody;   Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor);   Drug: oral isotretinoin
Outcome Measures: relapse-free survival;   complete remission
17 Recruiting 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
Condition: Neuroblastoma
Intervention: Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Outcome Measures: Assess the activity of high-dose 3F8/GM-CSF;   Apply real-time quantitative RT-PCR;   Monitor safety of the high-dose antibody treatment
18 Unknown  GM-CSF in Patients With Pulmonary Alveolar Proteinosis
Condition: Pulmonary Alveolar Proteinosis
Intervention: Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)
Outcome Measure:
19 Recruiting Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Condition: Breast Cancer
Interventions: Drug: Herceptin;   Drug: NeuVax vaccine;   Drug: GM-CSF
Outcome Measures: Disease-free survival (DFS);   Cardiac toxicity;   Local and systemic toxicities
20 Recruiting Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
Conditions: Disseminated Neuroblastoma;   Localized Resectable Neuroblastoma;   Localized Unresectable Neuroblastoma;   Regional Neuroblastoma;   Stage 4S Neuroblastoma
Interventions: Drug: isotretinoin;   Biological: sargramostim;   Biological: monoclonal antibody Ch14.18;   Biological: aldesleukin;   Other: laboratory biomarker analysis;   Procedure: quality-of-life assessment;   Other: pharmacological study
Outcome Measures: EFS;   OS;   Change in MRD;   Change in tumor biology;   Incidence of toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0;   Levels of ADCC;   Average level of HACA;   Historical data for the analogous patients;   13-cis-retinoic-acid pharmacokinetic parameters;   Presence of naturally occurring anti-glycan antibodies;   Genotype of Kir/Kir-Ligand;   EFS of patients from the non-randomized portion of the trial;   OS of patients from the non-randomized portion of the trial;   Cardiac repolarization;   Genotype of FcR;   Number of courses of therapy delivered

These studies may lead to new treatments and are adding insight into Leukine etiology and treatment.

A major focus of Leukine research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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