- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed, Combination therapy: ANBL19P1: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Jul 1, 2022 P2, N=40, Active, not recruiting, Recruiting --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Journal: NEBULISED SARGRAMOSTIM IN PULMONARY ALVEOLAR PROTEINOSIS. (Pubmed Central) - Jun 19, 2022 Incorporating the routine assessment of validated patient symptom scores with objective physiological measures will allow prediction of response to treatment and help guide management. This report describes the largest published experience of sargramostim use in Australia.
- |||||||||| Recentin (cediranib) / AstraZeneca
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) - May 20, 2022 P2, N=34, Active, not recruiting, This report describes the largest published experience of sargramostim use in Australia. Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment change: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - May 11, 2022 P1, N=50, Recruiting, Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 N=32 --> 50
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Using GM-CSF as a Host Directed Therapeutic Against COVID-19 (clinicaltrials.gov) - May 10, 2022 P2, N=2, Completed, N=32 --> 50 Recruiting --> Completed | N=30 --> 2 | Trial completion date: Jun 2022 --> Feb 2022 | Trial primary completion date: Jun 2021 --> Jan 2022
- |||||||||| SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax, Roswell Park Comprehensive Cancer Center
Final data from the phase 2a single-arm trial of SurVaxM for newly diagnosed glioblastoma. (Available On Demand; 375) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4392; P2 SurVaxM was effective at stimulating survivin-specific immune responses and the primary endpoint was met. SurVaxM represents a promising therapy for nGBM, including for those pts with unmethylated MGMT genes.
- |||||||||| Decadron (dexamethasone) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial completion, Enrollment change, Trial completion date: Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 18, 2022 P2/3, N=11, Completed, Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Sep 2021 Recruiting --> Completed | N=60 --> 11 | Trial completion date: Dec 2022 --> Dec 2021
- |||||||||| EGFR bi-armed autologous activated T cells / Barbara Ann Karmanos Cancer Institute
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: NCI-2015-01942: BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer (clinicaltrials.gov) - Apr 7, 2022 P1/2, N=2, Completed, Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2021
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date, Post-transplantation: GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov) - Apr 5, 2022 P2, N=38, Recruiting, Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2021 Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2024
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial primary completion date, Combination therapy: ANBL19P1: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Mar 29, 2022 P2, N=40, Recruiting, Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Nplate (romiplostim) / Amgen, Kyowa Kirin, Neupogen (filgrastim) / Kyowa Kirin, Amgen, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Journal: An update on romiplostim for treatment of acute radiation syndrome. (Pubmed Central) - Mar 18, 2022 We have discussed the latest FDA-approved agent, romiplostim, as a treatment modality for H-ARS. The nature of this agent and the preclinical and clinical work that preceded its FDA approval as a radiation medical countermeasure are discussed, as are the development and use of related thrombopoietic agents for the treatment of radiation-exposed victims.
- |||||||||| Leukine (sargramostim) / Partner Therap, SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax
Trial completion date: NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Mar 18, 2022 P2, N=66, Active, not recruiting, The nature of this agent and the preclinical and clinical work that preceded its FDA approval as a radiation medical countermeasure are discussed, as are the development and use of related thrombopoietic agents for the treatment of radiation-exposed victims. Trial completion date: Dec 2021 --> Dec 2023
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Enrollment change, Immunomodulating: GM-CSF for Immunomodulation Following Trauma (GIFT) Study (clinicaltrials.gov) - Feb 25, 2022 P4, N=108, Completed, Active, not recruiting --> Completed Active, not recruiting --> Completed | N=200 --> 108
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment closed, Trial completion date, Trial primary completion date: GRACE: GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study (clinicaltrials.gov) - Feb 25, 2022 P4, N=120, Active, not recruiting, Active, not recruiting --> Completed | N=200 --> 108 Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov) - Feb 21, 2022 P1/2, N=90, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Apr 2023 | Trial primary completion date: Jan 2024 --> Nov 2022
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial primary completion date: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - Feb 16, 2022 P1, N=32, Recruiting, Most patients have positive outcomes. Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Sep 2021 --> Sep 2022
- |||||||||| Leukine (sargramostim) / Partner Therap
Review, Journal: The Role of GM-CSF Autoantibodies in Infection and Autoimmune Pulmonary Alveolar Proteinosis: A Concise Review. (Pubmed Central) - Feb 5, 2022 In this article, we review the role of GM-CSF in aPAP pathogenesis and pulmonary homeostasis along with the increased incidence of infections (particularly opportunistic infections). Therefore, recombinant human GM-CSF products may have potential for treatment of aPAP and possibly other infectious and pulmonary diseases due to its pleotropic immunomodulatory actions.
- |||||||||| Leukine (sargramostim) / Partner Therap
Review, Journal: GM-CSF: Orchestrating the Pulmonary Response to Infection. (Pubmed Central) - Feb 4, 2022 Given the emergence of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and global spread of coronavirus disease 2019 (COVID-19), with subsequent acute respiratory distress syndrome, understanding basic lung physiology in infectious diseases is especially warranted. This review summarizes clinical and preclinical data for GM-CSF in respiratory infections, and the rationale for sargramostim (yeast-derived recombinant human [rhu] GM-CSF) as adjunctive treatment for COVID-19 and other pulmonary infectious diseases.
- |||||||||| Leukine (sargramostim) / Partner Therap, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Sargramostim and immune checkpoint inhibitors: combinatorial therapeutic studies in metastatic melanoma. (Pubmed Central) - Feb 2, 2022 Potential sargramostim applications in melanoma draw on the unique ability of GM-CSF to link innate and adaptive immune responses. We review preclinical and translational data describing the mechanism of action of sargramostim and synergy with immune checkpoint inhibitors to enhance efficacy and reduce treatment-related toxicity.
- |||||||||| Leukine (sargramostim) / Partner Therap
THE ROLE OF GROUP 3 INNATE LYMPHOID CELLS (ILC3) IN GM-CSF/CSF2RB-DEPENDENT INTESTINAL HOMEOSTASIS IN CROHN’S DISEASE () - Jan 28, 2022 - Abstract #CCCongress2022CCCongress_296; GM-CSF (Sargramostim) treatment showed a promising result for preventing intestinal injury and inflammation in both a murine and our novel zebrafish model...Our studies illuminate mechanisms of GM-CSF in perpetuating gut homeostasis through maintaining and regulating ILC3s. This novel aspect of regulating IBD pathogenesis through ILCs may lead to novel therapeutic targets.
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