Sargramostim

Generic Name: Sargramostim

Brand Names: Leukine

Drug Type: Biotech

CAS Number: 123774-72-1

Unique Ingredient Identifier: 5TAA004E22

Background: Sargramostim is a human recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) expressed in yeast. It is a glycoprotein that is 127 residues. Substitution of Leu23 leads to a difference from native protein.

Indication: For the treatment of cancer and bone marrow transplant

Associated Conditions: Acute Lymphoblastic Leukemia (ALL), Hematopoietic Subsyndrome of Acute Radiation Syndrome, Hodgkin's Lymphoma, Neutropenia, Non-Hodgkin's Lymphoma (NHL), Severe Infection

Associated Therapies: Allogenic bone marrow transplantation therapy, Autologous bone marrow transplantation therapy, Autologous peripheral haematopoietic stem cell transplant

Clinical Trials

N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

Phase 2

Recruiting

Conditions: Neuroblastoma
Childhood Neuroblastoma
High-risk Neuroblastoma

Interventions: Biological: DANYELZA
Biological: Sargramostim
Drug: Cytoxan
Drug: Topotecan
Drug: Vincristine
Drug: Doxorubicin
Drug: Ifosfamide
Drug: Etoposide
Drug: Carboplatin
Drug: Irinotecan
Drug: Temozolomide

First Posted Date: 2024-07-30

Last Posted Date: 2025-02-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 45

Registration Number: NCT06528496

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors

Phase 2

Not yet recruiting

Conditions: Malignant Solid Neoplasm
Digestive System Neuroendocrine Neoplasm
Pancreatic Neuroendocrine Neoplasm
Lung Neuroendocrine Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Incomplete Freund''s Adjuvant
Procedure: Magnetic Resonance Imaging
Drug: Temozolomide
Biological: Sargramostim
Biological: SVN53-67/M57-KLH Peptide Vaccine

First Posted Date: 2024-01-11

Last Posted Date: 2025-01-22

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 132

Registration Number: NCT06202066

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung

Phase 1

Suspended

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Malignant Neoplasm in the Lung
Metastatic Melanoma
Recurrent Melanoma
Unresectable Melanoma

Interventions: Biological: Aerosol Sargramostim
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Medical Device Usage and Evaluation
Biological: Nivolumab

First Posted Date: 2023-02-08

Last Posted Date: 2025-04-29

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT05717140

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease

Phase 1

Completed

Conditions: Parkinson's Disease and Parkinsonism

Interventions: Drug: Sargramostim

First Posted Date: 2023-01-10

Last Posted Date: 2024-11-06

Lead Sponsor: University of Nebraska

Target Recruit Count: 11

Registration Number: NCT05677633

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome

Phase 2

Withdrawn

Conditions: Down Syndrome

Interventions: Drug: Sargramostim for Injection
Drug: Saline Placebo

First Posted Date: 2022-08-01

Last Posted Date: 2025-04-02

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 42

Registration Number: NCT05482334

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Anatomic Stage IB Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8

Interventions: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Biological: Sargramostim

First Posted Date: 2022-07-13

Last Posted Date: 2024-11-20

Lead Sponsor: University of Washington

Target Recruit Count: 33

Registration Number: NCT05455658

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Biological: Sargramostim
Procedure: Computed Tomography
Procedure: Biopsy
Procedure: Biospecimen Collection

First Posted Date: 2022-02-16

Last Posted Date: 2025-04-15

Lead Sponsor: University of Washington

Target Recruit Count: 40

Registration Number: NCT05242965

Locations: 🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Biological: UV1
Drug: Sargramostim for Injection
Drug: Pembrolizumab injection

First Posted Date: 2021-10-12

Last Posted Date: 2022-03-09

Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Target Recruit Count: 75

Registration Number: NCT05075122

Locations: 🇩🇪
Universitätsklinikum Greifswald, Klinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie, Greifswald, Germany
🇩🇪
Universitätsklinikum Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie, Aachen, Germany
🇩🇪
Universitätsklinikum Leipzig, Klinik und Poliklinik für HNO Heilkunde, Leipzig, Germany

and more 7 locations

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Phase 2

Recruiting

Conditions: Alzheimer Disease

Interventions: Drug: Saline - placebo comparator
Drug: Sargramostim

First Posted Date: 2021-05-26

Last Posted Date: 2024-09-30

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 42

Registration Number: NCT04902703

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Sargramostim Use in COVID-19 to Recover Patient Health

Phase 2

Completed

Conditions: SARS-CoV Infection
Covid19

Interventions: Drug: Placebo
Drug: Sargramostim

First Posted Date: 2021-01-13

Last Posted Date: 2023-02-06

Lead Sponsor: Partner Therapeutics, Inc.

Target Recruit Count: 600

Registration Number: NCT04707664

Locations: 🇺🇸
Dorrington Medical Associates, Houston, Texas, United States
🇺🇸
Synergy Healthcare, Bradenton, Florida, United States
🇺🇸
Hometown Urgent Care and Research, Columbus, Ohio, United States

and more 33 locations

Drug Development Updates

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