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

Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Phase 3
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Schering-Plough
Registration Number
NCT00002070
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Children's Hosp of San Francisco, San Francisco, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Pacific Presbyterian, San Francisco, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Dr Douglas Dieterich, New York, New York, United States

and more 11 locations

A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Phase 1
Completed
Conditions
HIV Infections
Cytopenias
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Sandoz
Registration Number
NCT00002009
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Beth Israel Deaconess - West Campus, Boston, Massachusetts, United States

๐Ÿ‡บ๐Ÿ‡ธ

UCLA CARE Ctr, Los Angeles, California, United States

A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Not Applicable
Completed
Conditions
HIV Infections
Cytopenias
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Sandoz
Registration Number
NCT00002007
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Natl Cancer Institute, Bethesda, Maryland, United States

A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT00000896
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Ucsd, Avrc Crs, San Diego, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Colorado Hospital CRS, Aurora, Colorado, United States

๐Ÿ‡บ๐Ÿ‡ธ

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana, United States

A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

Not Applicable
Completed
Conditions
HIV Infections
Cytopenias
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Sandoz
Registration Number
NCT00002263
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Natl Cancer Institute / HIV / AIDS Malignancy Branch, Bethesda, Maryland, United States

A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma

Phase 1
Completed
Conditions
HIV Infections
Sarcoma, Kaposi
First Posted Date
2001-08-31
Last Posted Date
2021-11-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
18
Registration Number
NCT00000694
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Mem Sloan - Kettering Cancer Ctr, New York, New York, United States

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Not Applicable
Completed
Conditions
HIV Infections
Cytomegalovirus Retinitis
First Posted Date
2001-08-31
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
50
Registration Number
NCT00000989
Locations
๐Ÿ‡บ๐Ÿ‡ธ

UCLA CARE Center CRS, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts, United States

๐Ÿ‡บ๐Ÿ‡ธ

Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States

and more 1 locations

Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma

Phase 1
Completed
Conditions
Lymphoma, Non-Hodgkin
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
18
Registration Number
NCT00000689
Locations
๐Ÿ‡บ๐Ÿ‡ธ

USC CRS, Los Angeles, California, United States

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
36
Registration Number
NCT00001090
Locations
๐Ÿ‡บ๐Ÿ‡ธ

UAB AVEG, Birmingham, Alabama, United States

๐Ÿ‡บ๐Ÿ‡ธ

Univ. of Rochester AVEG, Rochester, New York, United States

๐Ÿ‡บ๐Ÿ‡ธ

JHU AVEG, Baltimore, Maryland, United States

and more 1 locations
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