- |||||||||| 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) - Jan 31, 2023
P1, N=50, Recruiting,
Trial completion date: Mar 2023 --> Jun 2024 | Trial primary completion date: Sep 2022 --> Jun 2023
- |||||||||| Leukine (sargramostim) / Partner Therap, Neupogen (filgrastim) / Kyowa Kirin, Amgen, NN1213 / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis (clinicaltrials.gov) - Jan 23, 2023
P2, N=31, Completed,
rhu GM-CSF (e.g., sargramostim) might ameliorate multiple diseases of GM-CSF deficiency or insufficiency and address a high unmet medical need. Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Mar 2022 | Trial primary completion date: Dec 2025 --> Mar 2022
- |||||||||| Leukine (sargramostim) / Partner Therap
A MULTIYEAR PHASE 1 CLINICAL TRIAL FOR SARGRAMOSTIM THERAPY IN PARKINSON'S DISEASE (EXHIBITION) - Dec 23, 2022 - Abstract #ADPD2023ADPD_1991;
Taken together, the data affirms long -term safety, Tr eg functional stability, and potential clinical efficacy of sargramostim in PD. Confirmation requiring larger numbers of enrolled patients is planned in a phase II evaluation.
- |||||||||| Leukine (sargramostim) / Partner Therap, Triolex (NE3107) / BioVie
Preclinical, Journal: Neuroinflammation, immune response and α-synuclein pathology: how animal models are helping us to connect dots. (Pubmed Central) - Dec 21, 2022
Lastly, this review also considers the current state of the ongoing clinical trials of new drugs designed to target these processes and delay the initiation or progression of the disease. Anti-inflammatory and immunomodulatory agents have been demonstrated to be very promising candidates for reducing disease progression; however, more efforts are needed to reduce the enormous gap between these and dopaminergic drugs, which have dominated the therapeutic market for the last sixty years.
- |||||||||| Leukine (sargramostim) / Partner Therap, Neupogen (filgrastim) / Kyowa Kirin, Amgen
Allogeneic Hematopoietic Cell Transplants As Dynamical Systems: Effect of Early-Term Immune Suppression Intensity on Long-Term T Cell Recovery () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1052;
There was a trend toward improved overall survival in the MMF15 arm with no difference in relapse or non-relapse mortality (NRM) (Figure 3). Reducing the duration of intense immunosuppression in the early term and the use of sargramostim following immunoablative conditioning and allogeneic HCT has the potential to promote robust T cell reconstitution and explicitly contribute to polyclonal diversity without increasing the risk of GVHD.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date: Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) (clinicaltrials.gov) - Dec 14, 2022
P2, N=203, Completed,
Reducing the duration of intense immunosuppression in the early term and the use of sargramostim following immunoablative conditioning and allogeneic HCT has the potential to promote robust T cell reconstitution and explicitly contribute to polyclonal diversity without increasing the risk of GVHD. Trial completion date: Jun 2021 --> Dec 2022
- |||||||||| Decadron (dexamethasone) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial completion date, Trial termination, Trial primary completion date: Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Dec 12, 2022
P2/3, N=11, Terminated,
Trial completion date: Jun 2021 --> Dec 2022 Trial completion date: Dec 2021 --> Jul 2022 | Completed --> Terminated | Trial primary completion date: Dec 2021 --> Jul 2022; Slow Accrual
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial initiation date, Trial suspension, Trial primary completion date: SALIENT: Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors (clinicaltrials.gov) - Dec 2, 2022
P2, N=65, Suspended,
These data provide strong support for further evaluation of sargramostim in high-risk patients with COVID-19. Trial completion date: Dec 2025 --> Sep 2025 | Initiation date: Apr 2023 --> Jan 2024 | Not yet recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Sep 2025
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial initiation date: Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome (clinicaltrials.gov) - Nov 14, 2022
P2, N=42, Not yet recruiting,
Sargramostim may be a potential adjunctive immunomodulator for selected patients with hematological malignancies and refractory IFDs. Initiation date: Sep 2022 --> Jan 2023
- |||||||||| Danyelza (naxitamab) - Y / mAbs Therap
First Report of Naxitamab Response for Brain Metastasis in Refractory High Risk Neuroblastoma (Anaheim Convention Center, Hall A, Board # 010) - Nov 10, 2022 - Abstract #AAPNCE2022AAP_NCE_2361;
Our case report suggests that NAX may penetrate the blood brain barrier under certain circumstances and benefit patients with HR-NB who have CNS disease. More information is needed to see if this can be a feasible option for HR-NB with brain metastasis and few options other options.
- |||||||||| Leukine (sargramostim) / Partner Therap
Journal: Reversing radiation-induced immunosuppression using a new therapeutic modality. (Pubmed Central) - Nov 8, 2022
While a limited number of recombinant protein therapies, such a Sargramostim, are approved for accelerating hematologic recovery, the pronounced role of granulocyte-macrophage colony-stimulating factor (GM-CSF or CSF2) as a proinflammatory cytokine poses additional challenges in creating immune dysfunction towards pathogenic autoimmune diseases...It was further tested in vivo in a mouse radiation-model with low-dose (3 mg/kg) intraperitoneal administration and was shown to regulate gene expression of epo in lung tissue as well as counter immune suppression. These results point to the broader applicability of our approach towards drug-discovery, and potential for further investigation of our lead molecule as reversible gene therapy to treat adverse health outcomes induced by radiation exposure.
- |||||||||| Leukine (sargramostim) / Partner Therap
Journal: Sargramostim in acute radiation syndrome. (Pubmed Central) - Nov 4, 2022
Therapy appeared effective with few, if any, adverse events; 18 survived. : This favorable benefit-to-risk ratio suggests giving sargramostim soon after exposure and is favored over HCT based on greater safety and fewer resource requirements, especially in the context of large-scale exposures which might occur after use of a tactical nuclear weapon or nuclear terrorism.
- |||||||||| Leukine (sargramostim) / Partner Therap, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (clinicaltrials.gov) - Nov 3, 2022
P2/3, N=600, Recruiting,
: This favorable benefit-to-risk ratio suggests giving sargramostim soon after exposure and is favored over HCT based on greater safety and fewer resource requirements, especially in the context of large-scale exposures which might occur after use of a tactical nuclear weapon or nuclear terrorism. Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
- |||||||||| EP-101 STEMVAC / EpiThany, University of Washington
Enrollment open: STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - Nov 3, 2022
P2, N=33, Recruiting,
Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023 Not yet recruiting --> Recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (clinicaltrials.gov) - Oct 21, 2022
P1, N=7, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=10 --> 7 | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Oct 2023
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date: GPAD-3: Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease (clinicaltrials.gov) - Oct 14, 2022
P2, N=176, Recruiting,
Recruiting --> Active, not recruiting | N=10 --> 7 | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Oct 2023 Trial completion date: Dec 2022 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Sep 2023
- |||||||||| Leukine (sargramostim) / Partner Therap
Monocyte biomarkers define sargramostim treatment outcomes for Parkinson's disease (SDCC Halls B-H) - Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_2932;
Pathway enrichments fromsingle cell-RNA sequencing and proteomic analyses from sargramostim-treated PD patientsdemonstrate a neuroprotective signature, including, but not limited to, antioxidant, anti-inflammatory, and autophagy genes and proteins (LRRK2, HMOX1, TLR2, TLR8, RELA, ATG7,and GABARAPL2). This monocyte profile provides a novel strategy to track clinical immune-based interventions.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial initiation date, Trial primary completion date: SALIENT: Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors (clinicaltrials.gov) - Sep 30, 2022
P2, N=65, Not yet recruiting,
Recruiting --> Completed Trial completion date: May 2024 --> Dec 2025 | Initiation date: Sep 2022 --> Apr 2023 | Trial primary completion date: May 2024 --> Dec 2025
- |||||||||| SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax, Roswell Park Comprehensive Cancer Center
Prospective randomized phase II placebo-controlled trial of SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma (SURVIVE) (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_442;
The primary objective is to determine the overall survival (OS), and the secondary objectives include progression-free survival (PFS), OS at pre-specified time points (OS-15, OS-18 and OS-24), PFS at pre-specified time points (PFS-3, PFS-6 and PFS-12) and evaluation of toxicities. Study duration is expected at 36 months, with enrollment ongoing at several centers and planned for total of 20 participating centers.
- |||||||||| SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax, Roswell Park Comprehensive Cancer Center
Phase II trial of SurVaxM plus temozolomide for newly diagnosed glioblastoma (Ballroom B) - Sep 28, 2022 - Abstract #SNO2022SNO_192;
P2
SurVaxM was effective at stimulating survivin-specific immune responses and the primary endpoint was met. SurVaxM represents a promising therapy for nGBM, randomized trial is ongoing.
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment open, Trial completion date, Combination therapy: STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov) - Sep 6, 2022
P1/2, N=31, Recruiting,
Trial primary completion date: Jul 2023 --> Aug 2022 Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025
- |||||||||| Leukine (sargramostim) / Partner Therap, SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax
Enrollment change, Trial primary completion date, Metastases: Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - Aug 12, 2022
P1, N=14, Recruiting,
Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Aug 2022 --> Jun 2023 N=10 --> 14 | Trial primary completion date: Aug 2022 --> Aug 2023
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Journal: Monocyte biomarkers define sargramostim treatment outcomes for Parkinson's disease. (Pubmed Central) - Jul 16, 2022
N=10 --> 14 | Trial primary completion date: Aug 2022 --> Aug 2023 This monocyte profile provides an "early" and unique biomarker strategy to track clinical immune-based interventions, but requiring validation in larger case studies.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date, Metastases: Sargramostim (GM-CSF) + PD-1 (clinicaltrials.gov) - Jul 7, 2022
P2, N=30, Recruiting,
Hyponatremia was the only dose limiting toxicity (DLT), though maximum tolerated dose (MTD) was not determined. Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial initiation date: SALIENT: Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors (clinicaltrials.gov) - Jul 5, 2022
P2, N=65, Not yet recruiting,
Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2024 Trial completion date: May 2025 --> May 2024 | Initiation date: Jun 2022 --> Sep 2022
|
