Sargramostim

Generic Name
Sargramostim
Brand Names
Leukine
Drug Type
Biotech
Chemical Formula
-
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

An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Phase 1
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Sandoz
Registration Number
NCT00002008
Locations
๐Ÿ‡บ๐Ÿ‡ธ

UCLA CARE Ctr, Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

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

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

Phase 3
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Schering-Plough
Registration Number
NCT00002070
Locations
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Children's Hosp of San Francisco, San Francisco, California, United States

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Pacific Presbyterian, San Francisco, California, United States

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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
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
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 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
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 Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma

Phase 1
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2021-11-03
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT00000681
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

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Pitt CRS, Pittsburgh, Pennsylvania, United States

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SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States

and more 2 locations

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
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

Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC

Phase 1
Completed
Conditions
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
60
Registration Number
NCT00000711
Locations
๐Ÿ‡บ๐Ÿ‡ธ

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, United States

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Phase 3
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2021-11-03
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
250
Registration Number
NCT00000658
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

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USC CRS, Los Angeles, California, United States

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Ucsf Aids Crs, San Francisco, California, United States

and more 19 locations

The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy

Phase 2
Completed
Conditions
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
108
Registration Number
NCT00000850
Locations
๐Ÿ‡บ๐Ÿ‡ธ

UCLA CARE Ctr, Los Angeles, California, United States

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Marin County Specialty Clinic, San Rafael, California, United States

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Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, United States

and more 36 locations
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