- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date, Immunomodulating: GM-CSF for Immunomodulation Following Trauma (GIFT) Study (clinicaltrials.gov) - Jul 15, 2020 P4, N=200, Active, not recruiting, Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Leukine (sargramostim) / Sanofi, Ghent University Hospital
[VIRTUAL] Antibody Against Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) and Inhaled GM-CSF for Pulmonary Alveolar Proteinosis (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3923; Methods : Daily inhaled rhGM-CSF (sargramostim) at a dose of 125 μg twice daily for seven days every other week for 24 weeks, or placebo, was administered to 64 patients with aPAP who had a partial pressure of arterial oxygen (PaO2) while breathing ambient air of less than 70 mmHg (or <75 mmHg in symptomatic patients)...Conclusions : The results of GMAb analyses suggest that the inhaled GM-CSF accelerated production of GMAb but did not change its neutralizing capacity. The higher level of GMAb during the inhalation might not be associated with AaDO2 worsening.
- |||||||||| Leukine (sargramostim) / Sanofi, Ghent University Hospital
[VIRTUAL] The Case of the Non-Resolving Pulmonary Edema: A Unique Presentation of Pulmonary Alveolar Proteinosis (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_2822; He was started on inhaled sargramostim until he could undergo whole lung lavage, which required veno-venous extra-corporeal membrane oxygenation (ECMO)...This case is an excellent example of anchoring bias in medicine, where our differential diagnosis was initially limited to cardiac etiologies due to the patient's initial presentation with ST elevation myocardial infarction. It was only failure to clinically respond to diuretics that we consciously changed our approach to reach the correct diagnosis.
- |||||||||| Leukine (sargramostim) / Sanofi, Ghent University Hospital
[VIRTUAL] Drowning in Surfactant - A Case of Pulmonary Alveolar Proteinosis (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_2820; Hematology was consulted and a 90-day Sargramostim step-up treatment regimen was constructed...However, in this case our patient responded to subcutaneous GM-CSF after failing the gold standard therapy. More research is required about the role of subcutaneous GM-CSF in the definitive treatment of PAP, especially in patients who do not respond to WLL, or in conjunction with WLL.
- |||||||||| Recentin (cediranib) / AstraZeneca
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) - Jun 26, 2020 P2, N=34, Active, not recruiting, An amendment to this paper has been published and can be accessed via the original article. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| BiovaxID (dasiprotimut-T) / National Cancer Institute, Accentia
Trial completion date: Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma (clinicaltrials.gov) - Jun 17, 2020 P2, N=26, Active, not recruiting, Suspended --> Recruiting Trial completion date: Jun 2020 --> Jun 2021
- |||||||||| Recentin (cediranib) / AstraZeneca
Enrollment closed, Enrollment change, Monotherapy, Metastases: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) - May 31, 2020 P2, N=34, Active, not recruiting, Recruiting --> Suspended Recruiting --> Active, not recruiting | N=70 --> 34
- |||||||||| Leukine (sargramostim) / Partner Therap, Neupogen (filgrastim) / Kyowa Kirin, Amgen, NN1213 / Novo Nordisk
Enrollment closed, Enrollment change: Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis (clinicaltrials.gov) - May 20, 2020 P2, N=31, Active, not recruiting, N=400 --> 600 Recruiting --> Active, not recruiting | N=60 --> 31
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Post-transplantation: GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov) - Apr 23, 2020 P2, N=38, Not yet recruiting, Recruiting --> Suspended Trial completion date: Mar 2022 --> May 2023
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov) - Apr 1, 2020 P3, N=1449, Active, not recruiting, Trial primary completion date: Mar 2020 --> Jul 2020 Completed --> Active, not recruiting
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov) - Mar 31, 2020 P3, N=105, Active, not recruiting, Recruiting --> Suspended Completed --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Trial completion date, Trial primary completion date: Study of the Safety & Efficacy of Leukine (clinicaltrials.gov) - Mar 16, 2020 P2, N=40, Completed, Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: May 2020 --> Dec 2019 | Trial primary completion date: May 2020 --> Dec 2019
- |||||||||| Leukine (sargramostim) / Sanofi, Ghent University Hospital
The Case of the Non-Resolving Pulmonary Edema: A Unique Presentation of Pulmonary Alveolar Proteinosis (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area D) - Mar 15, 2020 - Abstract #ATS2020ATS_5150; He was started on inhaled sargramostim until he could undergo whole lung lavage, which required veno-venous extra-corporeal membrane oxygenation (ECMO)...This case is an excellent example of anchoring bias in medicine, where our differential diagnosis was initially limited to cardiac etiologies due to the patient’s initial presentation with ST elevation myocardial infarction. It was only failure to clinically respond to diuretics that we consciously changed our approach to reach the correct diagnosis.
- |||||||||| Leukine (sargramostim) / Sanofi, Ghent University Hospital
Drowning in Surfactant - A Case of Pulmonary Alveolar Proteinosis (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area D) - Mar 15, 2020 - Abstract #ATS2020ATS_5148; Hematology was consulted and a 90-day Sargramostim step-up treatment regimen was constructed...However, in this case our patient responded to subcutaneous GM-CSF after failing the gold standard therapy. More research is required about the role of subcutaneous GM-CSF in the definitive treatment of PAP, especially in patients who do not respond to WLL, or in conjunction with WLL.
- |||||||||| Lorbrena (lorlatinib) / Pfizer, Azedra (iobenguane I 131) / Lantheus
Trial completion date, Trial primary completion date: Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Mar 13, 2020 P3, N=813, Recruiting, More research is required about the role of subcutaneous GM-CSF in the definitive treatment of PAP, especially in patients who do not respond to WLL, or in conjunction with WLL. Trial completion date: Jun 2026 --> Sep 2026 | Trial primary completion date: Jun 2026 --> Sep 2026
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial initiation date, Combination therapy: STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov) - Feb 25, 2020 P1/2, N=31, Not yet recruiting, IL-2-containing cycles were associated with increased toxicity. Initiation date: Jan 2020 --> Apr 2020
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