- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
New P2 trial, Metastases: Sargramostim (GM-CSF) + PD-1 (clinicaltrials.gov) - Jan 10, 2021 P2, N=30, Not yet recruiting,
- |||||||||| AST-302 / Aston Sci., EpiThany
Trial completion date, Trial primary completion date, Metastases: WOKVAC: Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (clinicaltrials.gov) - Dec 28, 2020 P1, N=24, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: Dec 2020 --> Mar 2025 | Trial primary completion date: Dec 2020 --> Mar 2025
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment open: A Phase II/III Study of Sargramostim (clinicaltrials.gov) - Dec 27, 2020 P2/3, N=60, Recruiting, Trial completion date: Dec 2020 --> Mar 2025 | Trial primary completion date: Dec 2020 --> Mar 2025 Not yet recruiting --> Recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment closed, Trial completion date, Trial primary completion date: Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC) (clinicaltrials.gov) - Dec 9, 2020 P4, N=80, Active, not recruiting, Trial completion date: Jul 2024 --> Jul 2026 Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial primary completion date: Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) (clinicaltrials.gov) - Dec 8, 2020 P2, N=203, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021 Trial primary completion date: Jun 2020 --> Dec 2020
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial primary completion date, Metastases: Pembrolizumab and GM-CSF in Biliary Cancer (clinicaltrials.gov) - Nov 25, 2020 P2, N=42, Active, not recruiting, Trial primary completion date: Dec 2020 --> Mar 2021 Trial primary completion date: Dec 2021 --> Dec 2020
- |||||||||| Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
Clinical, Review, Journal: Radioprotection and Radiomitigation: From the Bench to Clinical Practice. (Pubmed Central) - Nov 5, 2020 All FDA-approved radiation countermeasures (filgrastim, a recombinant DNA form of the naturally occurring granulocyte colony-stimulating factor, G-CSF; pegfilgrastim, a PEGylated form of the recombinant human G-CSF; sargramostim, a recombinant granulocyte macrophage colony-stimulating factor, GM-CSF) are classified as radiomitigators...Molecules under development with the aim of reaching clinical practice and other nonclinical applications are discussed. Assays to evaluate the biological effects of ionizing radiations are also analyzed.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
[VIRTUAL] Real World Risk of Splenic Rupture with G-CSF/GM-CSF Therapy: A Pharmacovigilance Assessment Using FDA Adverse Event Reporting System (FAERS) Database () - Nov 5, 2020 - Abstract #ASH2020ASH_4931; ROR was calculated separately for Pegfilgrastim 16.03 (95% CI 11.90-21.59), Filgrastim (49.79; 36.32-68.26), Lenograstim (133.82; 55.39-323.32), Filgrastim-sndz (87.87; 28.21-273.71), Filgrastim+Pegfilgrastim (35.01; 11.26-108.85), Filgrastim+Sargramostim (895.20; 214.83-3730.27) and for all G-CSF/GM-CSF drugs taken together (28.13; 22.92-34.52)...Conclusion This study demonstrates disproportionately elevated signals of developing splenic rupture in patient receiving G-CSF/GM-CSF therapy as compared to those receiving other drugs based on the FAERS database. Physicians should be aware of this rare adverse event as it could potentially lead to life-threatening outcomes.
- |||||||||| Leukine (sargramostim) / Partner Therap, Danyelza (naxitamab) - Y / mAbs Therap
Trial completion date, Trial primary completion date: Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - Oct 22, 2020 P2, N=62, Recruiting, Physicians should be aware of this rare adverse event as it could potentially lead to life-threatening outcomes. Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Enrollment open, Trial completion date, Trial primary completion date: Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (clinicaltrials.gov) - Oct 19, 2020 P1, N=10, Recruiting, Suspended --> Recruiting Active, not recruiting --> Recruiting | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Sep 2020 --> Sep 2022
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date, Metastases: Pembrolizumab and GM-CSF in Biliary Cancer (clinicaltrials.gov) - Sep 11, 2020 P2, N=42, Active, not recruiting, Active, not recruiting --> Completed Trial completion date: May 2021 --> Dec 2023 | Trial primary completion date: May 2020 --> Dec 2021
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - Sep 9, 2020 P2, N=45, Active, not recruiting, Trial completion date: May 2021 --> Dec 2023 | Trial primary completion date: May 2020 --> Dec 2021 Suspended --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment open, Trial primary completion date: iLeukPulm: Study of Sargramostim in Patients With COVID-19 (clinicaltrials.gov) - Aug 19, 2020 P2, N=60, Recruiting, Conclusions High-dose naxitamab-based chemoimmunotherapy is safe and effective against chemoresistant HR-NB. Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2020 --> Jan 2021
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - Aug 8, 2020 P2, N=95, Active, not recruiting, Active, not recruiting --> Recruiting Suspended --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment open, Post-transplantation: GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov) - Aug 7, 2020 P2, N=38, Recruiting, These results indicate that GM-CSF/ sargramostim shows promise as a potentially safe treatment for AD and provides support for our Alzheimer’s Association “Part the Cloud”-funded trial with a longer, 24-week-long treatment period. Not yet recruiting --> Recruiting
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov) - Jul 26, 2020 P1/2, N=31, Not yet recruiting, These results indicate that GM-CSF/sargramostim shows promise as a potential treatment for AD and that our Alzheimers Association Part the Cloud-funded 24-week treatment trial is warranted. Trial completion date: Dec 2023 --> Dec 2024 | Initiation date: Jun 2020 --> Jan 2021 | Trial primary completion date: Dec 2022 --> Dec 2023
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