MedPath

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

Sargramostim (GM-CSF) + PD-1

Phase 2
Withdrawn
Conditions
Unresectable Melanoma
Metastatic Melanoma
Stage III Melanoma
Stage IV Melanoma
Interventions
First Posted Date
2021-01-11
Last Posted Date
2023-05-22
Lead Sponsor
Dana-Farber Cancer Institute
Registration Number
NCT04703426

A Phase II/III Study of Sargramostim

Phase 2
Completed
Conditions
COVID-19
Interventions
Drug: Placebo
First Posted Date
2020-11-24
Last Posted Date
2024-07-19
Lead Sponsor
Nobelpharma
Target Recruit Count
70
Registration Number
NCT04642950
Locations
🇯🇵

Mishuku Hospital, Meguro-ku, Tokyo, Japan

🇯🇵

Kanagawa Cardiovascular and Respiratory Center, Yokohama City, Kanagawa, Japan

🇯🇵

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku, Tokyo, Japan

and more 4 locations

Study of Sargramostim in Patients With COVID-19

Phase 2
Completed
Conditions
COVID-19
SARS-CoV-2
Interventions
Drug: Standard of care
First Posted Date
2020-06-02
Last Posted Date
2023-08-23
Lead Sponsor
Partner Therapeutics, Inc.
Target Recruit Count
123
Registration Number
NCT04411680
Locations
🇺🇸

Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, Texas, United States

🇺🇸

University of Utah Health, Salt Lake City, Utah, United States

🇺🇸

St. Jude Medical Center, Fullerton, California, United States

and more 8 locations

Using GM-CSF as a Host Directed Therapeutic Against COVID-19

Phase 2
Completed
Conditions
COVID
Sars-CoV2
ARDS, Human
Interventions
Other: Normal Saline 0.9%
First Posted Date
2020-05-26
Last Posted Date
2022-05-10
Lead Sponsor
Singapore General Hospital
Target Recruit Count
2
Registration Number
NCT04400929
Locations
🇸🇬

Singapore General Hospital, Singapore, Singapore

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Phase 2
Active, not recruiting
Conditions
Ganglioneuroblastoma, Nodular
Neuroblastoma
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: FDG-Positron Emission Tomography
Radiation: Iobenguane I-123
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
First Posted Date
2020-05-12
Last Posted Date
2024-10-22
Lead Sponsor
Children's Oncology Group
Target Recruit Count
41
Registration Number
NCT04385277
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

and more 74 locations

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Phase 2
Completed
Conditions
Malignant Melanoma
Interventions
First Posted Date
2020-05-11
Last Posted Date
2025-01-14
Lead Sponsor
Ultimovacs ASA
Target Recruit Count
156
Registration Number
NCT04382664
Locations
🇺🇸

Highlands Oncology Group, Fayetteville, Arkansas, United States

🇺🇸

California Cancer Associates for Research & Excellence (CCARE, San Marcos, California, United States

🇺🇸

University of California Irvine Health, Orange, California, United States

and more 34 locations

Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)

Phase 4
Completed
Conditions
COVID-19
Interventions
Other: Control
First Posted Date
2020-03-30
Last Posted Date
2022-11-16
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
87
Registration Number
NCT04326920
Locations
🇧🇪

AZ Sint Jan Brugge, Brugge, Belgium

🇧🇪

University Hospital Ghent, Gent, Belgium

🇧🇪

AZ Delta Roeselare, Roeselare, Belgium

and more 1 locations

GM-CSF With Post-Transplant Cyclophosphamide

Phase 2
Recruiting
Conditions
Transplant-Related Hematologic Malignancy
Interventions
Other: Control Arm
First Posted Date
2020-01-23
Last Posted Date
2025-04-15
Lead Sponsor
Northside Hospital, Inc.
Target Recruit Count
38
Registration Number
NCT04237623
Locations
🇺🇸

Northside Hospital, Atlanta, Georgia, United States

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

Phase 1
Recruiting
Conditions
Relapsed Neuroblastoma
Refractory Neuroblastoma
Interventions
First Posted Date
2019-12-26
Last Posted Date
2025-05-13
Lead Sponsor
Nationwide Children's Hospital
Target Recruit Count
31
Registration Number
NCT04211675
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma

Phase 1
Completed
Conditions
Pleural Mesothelioma
Wilms Tumor
Mesothelioma
Interventions
First Posted Date
2019-07-31
Last Posted Date
2025-05-13
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
10
Registration Number
NCT04040231
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Cancer Center @ Commack, Commack, New York, United States

and more 3 locations
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