Leukine

(sargramostim)

Phase 3Protein / enzyme

Sargramostim is used to help boost white blood cell production in cancer patients undergoing chemotherapy or bone marrow transplants, helping their immune system recover and fight infections.[1] Leukine is currently being investigated across 19 indications[3], with its most advanced program in Phase 3.[1]

Leukine is one of 269 biologic programs targeting Glioblastoma. It is currently in Phase 3.

Indications

306

Total Trials

Active Trials

268

Competitors

Pipeline

Status by Indication[3][1]

Indication

GlioblastomaCompleted

Anatomic Stage III Breast Cancer AJCC V8Recruiting

Myeloid NeoplasmActive, not recruiting

High-Risk NeuroblastomaCompleted

Bilateral Breast CarcinomaActive, not recruiting

Stage III Cutaneous Melanoma AJCC V7Active, not recruiting

Recurrent GanglioneuroblastomaNot yet recruiting

Aplastic AnemiaActive, not recruiting

Anatomic Stage IB Breast Cancer AJCC V8Active, not recruiting

GlioblastomaPhase 2

Completed

Recruiting

Anatomic Stage III Breast Cancer AJCC V8Preclinical

Recruiting

Myeloid NeoplasmPreclinical

Active, not recruiting

High-Risk NeuroblastomaPhase 3

Completed

Bilateral Breast CarcinomaPhase 2

Active, not recruiting

Stage III Cutaneous Melanoma AJCC V7Preclinical

Active, not recruiting

Recurrent GanglioneuroblastomaPreclinical

Not yet recruiting

Aplastic AnemiaPreclinical

Active, not recruiting

Anatomic Stage IB Breast Cancer AJCC V8Phase 2

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Fludara

Sanofi

Phase 3

47 2

Ninlaro

Takeda

Phase 3

18 3

Venclexta

AbbVie

Phase 3

17 4

Keytruda

Merck & Co.

Phase 3

17 5

Opdivo

Bristol-Myers Squibb

Phase 3

11 6

Azatiq

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

23 7

Treanda

AAzurity Pharmaceuticals

Phase 3

19 8

Neulasta

Amgen

Phase 3

5 9

Elranatamab

Cytosar

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Alzheimer's Disease

NCT04902703

Q3 2027

Phase 2Active, not recruiting

Neuroblastoma

NCT04385277

Q1 2029

Phase 2Active, not recruiting

Neuroblastoma

NCT03794349

Clinical

Trials by Indication[1]

Lymphoma15 trials

Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Terminated·—·Phase 1·NCT00003567·8 enrolled

Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma

Terminated·FFavrille·Phase 2·NCT00104819·238 enrolled

Liposomal Doxorubicin Plus Combination Chemotherapy in Treating Patients With AIDS-Associated Non-Hodgkin's Lymphoma

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT00004162·48 enrolled

Show 12 more trials

Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00027937

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000689·18 enrolled

GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00521014·14 enrolled

Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002697

Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma

Completed·GGenitope Corporation·Phase 2·NCT00071955

Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00003397·25 enrolled

Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00073931·25 enrolled

Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00411086·60 enrolled

Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00308087·75 enrolled

Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

Terminated·UUniversity of Nebraska·Phase 2·NCT00006478·19 enrolled

Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00621036

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

Completed·AAIDS Malignancy Consortium·Phase 2·NCT00389818·43 enrolled

Melanoma13 trials

Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant Melanoma

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT00003897·18 enrolled

Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00089063·40 enrolled

Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Completed·—·Phase 2·NCT00014092

Show 10 more trials

Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

Completed·AAlliance for Clinical Trials in Oncology·Phase 1·NCT00017121·40 enrolled

Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma

Completed·NNational Cancer Institute (NCI)·N/A·NCT00006243·30 enrolled

Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Suspended·UUniversity of Virginia·Phase 2·NCT00278122·42 enrolled

Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003362

Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma

Completed·UUniversity of Alabama at Birmingham·Phase 1/2·NCT00004184·50 enrolled

Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00005610·28 enrolled

Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

Terminated·UUniversity of Southern California·Phase 2·NCT00006113·25 enrolled

Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

Completed·CCraig L Slingluff, Jr·Phase 2·NCT00089193

Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

Completed·UUniversity of Southern California·Phase 2·NCT00031733·60 enrolled

Radiofrequency Therapy-Induced Endogenous Heat-Shock Proteins With or Without Radiofrequency Ablation or Cryotherapy in Treating Patients With Stage IV Melanoma

Completed·MMayo Clinic·Phase 1·NCT00568763·11 enrolled

Breast Cancer11 trials

Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02636582·43 enrolled

Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT00048893·37 enrolled

Biological Therapy in Treating Women With Metastatic Breast Cancer

Unknown status·SSt. Luke's Medical Center·Phase 1/2·NCT00002780·60 enrolled

Show 8 more trials

Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer

Completed·UUniversity of Washington·Phase 2·NCT00343109·38 enrolled

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer

Completed·MMayo Clinic·Phase 1·NCT00640861·45 enrolled

Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT00266110·17 enrolled

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

Completed·UUniversity of Washington·Phase 1/2·NCT00791037·23 enrolled

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00003972·280 enrolled

Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00179309·48 enrolled

Biological Therapy in Treating Women With Stage IV Breast Cancer

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT00027807·6 enrolled

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

Completed·UUniversity of Washington·Phase 1·NCT02780401·32 enrolled

Multiple Myeloma9 trials

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00014508

SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy

Active, not recruiting·RRoswell Park Cancer Institute·Phase 1·NCT02334865·18 enrolled

Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers

Unknown status·MMedical College of Wisconsin·Phase 2·NCT00003163·10 enrolled

Show 6 more trials

Vaccine Therapy in Treating Patients With Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019097

Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon Alfa in Treating Patients With Multiple Myeloma

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00005987·87 enrolled

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Completed·SSWOG Cancer Research Network·Phase 2·NCT00040937·147 enrolled

Interferon Alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma

Completed·UUniversity of Tennessee·Phase 2·NCT00003007

Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma

Completed·MMayo Clinic·Phase 1·NCT00477815·30 enrolled

Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation

Completed·FFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium·Phase 1·NCT00002787·22 enrolled

Neuroblastoma9 trials

Multiple Therapies in Treating Patients With Advanced Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00040872

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma

Completed·CChildren's Oncology Group·Phase 2·NCT00017368·42 enrolled

Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

Completed·CChildren's Oncology Group·Phase 2·NCT01334515·52 enrolled

Show 6 more trials

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03786783·42 enrolled

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT03794349·94 enrolled

Combination Chemotherapy in Treating Children With Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00003093·573 enrolled

Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk, Refractory or Relapsed Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00450307·32 enrolled

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00026312·1,449 enrolled

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

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT04385277·41 enrolled

76 more indications

Prostate Cancer8 trials

GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT00305669·24 enrolled

Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

Completed·—·Phase 1/2·NCT00939510·32 enrolled

The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer

Completed·UUniversity of Colorado, Denver·Phase 1·NCT02250014·19 enrolled

Show 5 more trials

153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00450619·44 enrolled

Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00450463·64 enrolled

GM-CSF in Treating Patients With Relapsed Prostate Cancer

Completed·—·Phase 2·NCT00908141·17 enrolled

GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

Completed·TThe Cleveland Clinic·Phase 2·NCT00400517·28 enrolled

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00108732·50 enrolled

Chronic Lymphocytic Leukemia7 trials

Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Terminated·—·Phase 1·NCT00014560·3 enrolled

Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00265915

Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT00669318·41 enrolled

Show 4 more trials

Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00546377·50 enrolled

FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00381004·60 enrolled

Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00323557·39 enrolled

Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia

Completed·MMayo Clinic·Phase 2·NCT00562328·33 enrolled

Metastatic Melanoma7 trials

Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

Completed·—·Phase 2·NCT00085423·20 enrolled

Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

Unknown status·HHerbert Irving Comprehensive Cancer Center·Phase 1·NCT00037037

Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

Completed·HHoag Memorial Hospital Presbyterian·Phase 2·NCT00436930·200 enrolled

Show 4 more trials

Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019890

Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019383

Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00071981·175 enrolled

Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00006385

Chronic Myelogenous Leukemia5 trials

Combination Chemotherapy and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002598·30 enrolled

Chemotherapy and Peripheral Stem Cell Transplantation Followed by Immunotherapy in Treating Patients With Chronic Myelogenous Leukemia

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00003727·22 enrolled

Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00002778·40 enrolled

Show 2 more trials

High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00050531·94 enrolled

Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

Completed·WWake Forest University Health Sciences·Phase 2·NCT00072579

Acute Myeloid Leukemia4 trials

Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission

Unknown status·TThe Vaccine Company·Phase 3·NCT00454168·244 enrolled

Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00046930·449 enrolled

S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00066794·69 enrolled

Show 1 more trial

Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2/3·NCT00630565·12 enrolled

Hematologic Cancer4 trials

Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer

Unknown status·BBenovus Bio, Inc.·Phase 1·NCT02240537·4 enrolled

Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors

Completed·SScripps Health·Phase 2·NCT00003269·20 enrolled

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT00304018·5 enrolled

Show 1 more trial

Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT00301951·7 enrolled

Leukemia4 trials

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia

Completed·UUniversity of Nebraska·Phase 2·NCT00002638·30 enrolled

Mitomycin and Mitoxantrone in Treating Patients With Acute Myelogenous Leukemia

Completed·—·Phase 1·NCT00003003·29 enrolled

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

Completed·—·Phase 2·NCT00047021·3 enrolled

Show 1 more trial

Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00002766·170 enrolled

Myelodysplastic Syndrome4 trials

MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00462605·24 enrolled

Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00004918·69 enrolled

Vaccine Therapy and GM-CSF in Treating Patients With Low-Risk or Intermediate-Risk Myelodysplastic Syndrome

Unknown status·TThe Vaccine Company·Phase 2·NCT00513578·30 enrolled

Show 1 more trial

Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00425477·26 enrolled

Crohn's Disease4 trials

Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00206713·264 enrolled

Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

Completed· Sanofi logo

Sanofi·Phase 2·NCT00206596·127 enrolled

Study of Sargramostim in Moderately to Severely Active Crohn's Disease

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00329537·11 enrolled

Show 1 more trial

Open-label Trial of Leukine in Active Crohn's Disease

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00206700·378 enrolled

Pancreatic Cancer3 trials

BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 1/2·NCT02620865·2 enrolled

Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer

Completed·SSt. Vincent Medical Center - Los Angeles·Phase 2·NCT00002773

Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Completed·RRoyal Liverpool University Hospital·Phase 3·NCT00425360·1,110 enrolled

Chemotherapy3 trials

Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

Terminated·MM.D. Anderson Cancer Center·N/A·NCT00673179·7 enrolled

Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus

Terminated·GGynecologic Oncology Group·Phase 2·NCT00033644

Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00012376·35 enrolled

Primary Peritoneal Cancer3 trials

Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

Completed·UUniversity of Virginia·Phase 1·NCT00091273·9 enrolled

Activated T-cell Therapy, Low-Dose Aldesleukin, and Sargramostim in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That is Stage III-IV, Refractory, or Recurrent

Withdrawn·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT02470559

Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Completed·LLudwig Institute for Cancer Research·Phase 1·NCT00803569·13 enrolled

Advanced Cancer3 trials

Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Completed·SSt. Vincent Medical Center - Los Angeles·Phase 2·NCT00002475·40 enrolled

Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer

Completed·YYale University·Phase 1/2·NCT00002950·25 enrolled

PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00088413·51 enrolled

Bone Marrow Transplantation3 trials

Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT00002552·40 enrolled

Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00011934

Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00003961

Colorectal Cancer3 trials

Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer

Completed·SSt. Luke's Medical Center·Phase 1/2·NCT00030342·60 enrolled

Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer

Unknown status·SSt. Luke's Medical Center·Phase 1·NCT00016042

Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer

Completed·MMichael Morse, MD·Phase 2·NCT00103142·74 enrolled

COVID-193 trials

Study of Sargramostim in Patients With COVID-19

Completed·PPartner Therapeutics, Inc.·Phase 2·NCT04411680·123 enrolled

Sargramostim Use in COVID-19 to Recover Patient Health

Completed·PPartner Therapeutics, Inc.·Phase 2·NCT04707664·600 enrolled

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

Completed·SSingapore General Hospital·Phase 2·NCT04400929·2 enrolled

Rhabdomyosarcoma3 trials

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00002995·483 enrolled

Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00003958·702 enrolled

Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00025363·150 enrolled

Parkinson's Disease3 trials

Biomarker Assessments of Leukine During Treatment of Parkinson's Disease

Completed·UUniversity of Nebraska·Phase 1·NCT03790670·7 enrolled

Leukine (Sargramostim) for Parkinson's Disease

Completed·UUniversity of Nebraska·Phase 1·NCT01882010·37 enrolled

Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease

Completed·UUniversity of Nebraska·Phase 1·NCT05677633·11 enrolled

HIV infection2 trials

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

Completed· Novartis logo

Novartis·N/A·NCT00002007

A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Completed· Novartis logo

Novartis·Phase 1·NCT00002006

Metastatic Colorectal Cancer2 trials

Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer

Withdrawn·JJames Ahlgren·Phase 2·NCT00002664

Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00088933·60 enrolled

Fallopian Tube Cancer2 trials

Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy

Completed·UUniversity of Washington·Phase 2·NCT00466960·21 enrolled

Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

Completed·RRoswell Park Cancer Institute·Phase 1·NCT01673217·18 enrolled

Ovarian Cancer2 trials

p53 Vaccine for Ovarian Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00001827·21 enrolled

Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

Completed·UUniversity of Washington·Phase 1·NCT00436254·66 enrolled

Osteosarcoma2 trials

Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

Completed·CChildren's Oncology Group·Phase 2·NCT00066365·49 enrolled

Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02484443·41 enrolled

Metastatic Prostate Cancer2 trials

Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00045227

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00004029·46 enrolled

Malignant Glioma2 trials

Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

Completed·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00008008·40 enrolled

Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma

Completed·RRoswell Park Cancer Institute·Phase 1·NCT01250470·9 enrolled

Dendritic Cell2 trials

Sargramostim for Myeloid Dendritic Cell Deficiency

Completed·JJohns Hopkins University·Phase 1·NCT01871467·2 enrolled

Sargramostim for Myeloid Dendritic Cell Deficiency

Terminated·UUniversity of Florida·Phase 2·NCT03063242·4 enrolled

Acute Lymphoblastic Leukemia2 trials

Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00053131

Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00002514·1,929 enrolled

Moderate to Severe Crohn's Disease2 trials

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Completed· Sanofi logo

Sanofi·Phase 3·NCT00206674·286 enrolled

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00295165·33 enrolled

Metastatic Cancer1 trial

Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00028496·48 enrolled

Phase II1 trial

A Phase II/III Study of Sargramostim

Completed·NNobelpharma·Phase 2/3·NCT04642950·70 enrolled

Biological Therapy1 trial

Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019084

Effectiveness1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000850·108 enrolled

Mantle Cell Lymphoma1 trial

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006747·4 enrolled

Kaposi's sarcoma1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000681·24 enrolled

Lung Cancer1 trial

Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT00514215·8 enrolled

Stage III Colon Cancer1 trial

GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer

Completed·UUniversity of Rochester·Phase 2·NCT00262808·50 enrolled

Transitional Cell Carcinoma1 trial

Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas

Completed·LLudwig Institute for Cancer Research·Phase 1·NCT00070070·6 enrolled

Metastatic Neuroendocrine Tumor1 trial

Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

Completed·RRoswell Park Cancer Institute·Phase 1·NCT03879694·19 enrolled

Malignant Solid Tumors1 trial

Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors

Unknown status·MMilton S. Hershey Medical Center·Phase 1·NCT00436761·20 enrolled

Trial1 trial

PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

Terminated·VVeeda Oncology·Phase 2·NCT00313482·35 enrolled

Cytomegalovirus (CMV)1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000989·50 enrolled

Oligodendroglioma1 trial

Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT00004024·60 enrolled

Urothelial Cancer1 trial

Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer

Terminated·UUniversity of Kentucky·Phase 3·NCT00237575·100 enrolled

Retinitis1 trial

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

Completed·SSchering-Plough·Phase 3·NCT00002070

Pulmonary Alveolar Proteinosis1 trial

Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

Completed·NNiigata University Medical & Dental Hospital·Phase 2·NCT02835742·78 enrolled

Interleukin1 trial

Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors

Completed·GGeorgetown University·Phase 2·NCT00003125·24 enrolled

Infection1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT00002008

Hematological Malignancy1 trial

Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis

Completed·VVirginia Commonwealth University·Phase 2·NCT02593123·31 enrolled

Stem Cell Transplant1 trial

Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT00448201·71 enrolled

Patients With Solid Tumors1 trial

HER2-Peptide Vaccination of Patients With Solid Tumors

Completed·TTechnical University of Munich·Phase 1·NCT02276300·2 enrolled

AIDS1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000711·60 enrolled

Age1 trial

SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study

Completed·NNiigata University Medical & Dental Hospital·Phase 1·NCT02840708·14 enrolled

Immunogenicity1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001090·36 enrolled

Respiratory Failure1 trial

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

Completed·UUniversity Hospital, Ghent·Phase 4·NCT04326920·87 enrolled

Glioblastoma Multiforme1 trial

Biological Therapy in Treating Patients With Glioblastoma Multiforme

Completed·TThe Cleveland Clinic·Phase 2·NCT00003185·40 enrolled

Diffuse Large B-Cell Lymphoma1 trial

GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Suspended·FFavrille·Phase 3·NCT00324831·480 enrolled

Donor1 trial

Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors

Completed·WWashington University School of Medicine·Phase 2·NCT01158118·48 enrolled

Mesothelioma1 trial

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

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04040231·10 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00053989·41 enrolled

Germ Cell Tumor1 trial

Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors

Completed·CChildren's Oncology Group·Phase 2·NCT00002594·31 enrolled

Gastrointestinal1 trial

Vaccine Therapy in Treating Patients With Cancer of the Gastrointestinal Tract

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT00012246·7 enrolled

Neutropenia1 trial

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

Completed· Novartis logo

Novartis·N/A·NCT00002263

Myeloid Neoplasm1 trial

Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms

Completed·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT00665002·16 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT00206661·22 enrolled

PD-11 trial

Sargramostim (GM-CSF) + PD-1

Withdrawn·—·Phase 2·NCT04703426

Pancreas Cancer1 trial

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT00669734·18 enrolled

Glioblastoma1 trial

Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Completed·DDavid Peereboom·Phase 2·NCT04013672·41 enrolled

Mucositis1 trial

Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer

Completed·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT00004256

Relapsed or Refractory1 trial

Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors

Completed·MMayo Clinic·Phase 1·NCT02444546·6 enrolled

Non-Small Cell Lung Cancer1 trial

Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and GM-CSF in Treating Patients With Recurrent, Refractory, or Metastatic Non-Small Cell Lung Cancer

Terminated·RRoger Williams Medical Center·Phase 1·NCT00569296·5 enrolled

Alzheimer's Disease1 trial

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

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT04902703·42 enrolled

Vaccine1 trial

Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00009958·42 enrolled

Squamous Cell Carcinoma1 trial

Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity

Completed·GGliknik Inc.·Phase 2·NCT02873819·80 enrolled

Intravenous1 trial

Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation

Completed·PPartner Therapeutics, Inc.·Phase 1·NCT05366283·42 enrolled

Kidney Cancer1 trial

Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006483·27 enrolled

Unspecified2 trials

MIBG With Dinutuximab +/- Vorinostat

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT03332667·45 enrolled

GM-CSF With Post-Transplant Cyclophosphamide

Recruiting·NNorthside Hospital, Inc.·Phase 2·NCT04237623·38 enrolled

Sources

References

[1]
ClinicalTrials.gov — 306 trial records for sargramostim. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sargramostim compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sargramostim. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Granulocyte-Macrophage Colony-Stimulating Factor Receptor Agonist[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Sanofi