- |||||||||| Kisqali (ribociclib) / Novartis
Trial completion date, Combination therapy: Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL (clinicaltrials.gov) - Feb 15, 2024 P1, N=45, Active, not recruiting, The decreased expression of DUSP1 may be caused by silencer-promoter loops and may act as a crucial role in the intercellular communication of epithelial cells and fibroblasts. Trial completion date: Mar 2024 --> Sep 2024
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
TREOSULFAN-FLUDARABINE CONDITIONING REGIMEN WITH POST-TRANSPLANT HIGH-DOSE CYCLOPHOSPHAMIDE: A RETROSPECTIVE ANALYSIS (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2778; In combination with PTCy, short courses of tacrolimus or everolimus and mycophenolate mofetil (MMF) were used as GVHD prophylaxis. Treosulfan-fludarabine conditioning regimen combined with PTCy had low transplantation-related mortality and acceptable relapse rate, especially taking into account the relatively high age of the patients, high or very high DRI in more than half of the patients, and the high proportion of patients with active disease and/or positive MRD at transplant.
- |||||||||| Ovastat (treosulfan) / Medac, Medexus
TREOSULFAN-FLUDARABINE CONDITIONING REGIMEN WITH POST-TRANSPLANT HIGH-DOSE CYCLOPHOSPHAMIDE: A RETROSPECTIVE ANALYSIS (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2777; In combination with PTCy, short courses of tacrolimus or everolimus and mycophenolate mofetil (MMF) were used as GVHD prophylaxis. Treosulfan-fludarabine conditioning regimen combined with PTCy had low transplantation-related mortality and acceptable relapse rate, especially taking into account the relatively high age of the patients, high or very high DRI in more than half of the patients, and the high proportion of patients with active disease and/or positive MRD at transplant.
- |||||||||| everolimus / Generic mfg.
Journal: Everolimus inhibits hepatoblastoma by inducing autophagy-dependent ferroptosis. (Pubmed Central) - Feb 13, 2024 Importantly, the induction of ferroptosis by everolimus was significantly reversed in the presence of autophinib, an autophagy inhibitor, indicating the autophagy-dependent of everolimus-induced ferroptosis. Taken together, these findings suggest that everolimus holds promise as an effective anti-hepatoblastoma drug, with its mechanism of action potentially involving the induction of autophagy-dependent ferroptosis in hepatoblastoma cells.
- |||||||||| everolimus / Generic mfg.
Journal, Checkpoint inhibition: Efficacy of Immune Checkpoint Inhibitors vs. Tyrosine Kinase Inhibitors/Everolimus in Adjuvant Renal Cell Carcinoma: Indirect Comparison of Disease-Free Survival. (Pubmed Central) - Feb 10, 2024 This study further summarizes and analyzes the potential mechanism of the PI3K-AKT signaling pathway in MTA resistance and reveals that the PIK3CA H1047R mutation may be a potential molecular marker for the efficacy prediction of mTOR inhibitors, providing new insights and potential therapeutic strategies for the application of MTAs to MBC patients. This novel approach to investigating survival has allowed us to conduct all indirect head-to-head comparisons between these agents in a context where no "real" comparative trials have been conducted.
- |||||||||| Kisqali (ribociclib) / Novartis
Trial completion, Combination therapy, Metastases: A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors (clinicaltrials.gov) - Feb 2, 2024 P2, N=21, Completed, Data corroborate the key role of mitochondriogenesis to treatment of MS progression, and for the first time disclose the translational potential of mTOR inhibitors in PMS therapy. Active, not recruiting --> Completed
- |||||||||| Cosentyx (secukinumab) / Novartis
Journal: Enhanced Anti-Pediatric Sarcomas Effect of Everolimus with Secukinumab by Targeting IL-17A. (Pubmed Central) - Jan 31, 2024 However, everolimus induces sarcoma cells to produce IL-17A, which promotes tumor cell survival and counteracts its anti-pediatric sarcomas effect. The combination of secukinumab effectively eliminates the effects of IL-17A, thereby improving the therapeutic efficacy of everolimus in the context of pediatric sarcomas.
- |||||||||| everolimus / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date: EXIST-LT: Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus (clinicaltrials.gov) - Jan 29, 2024 P4, N=15, Completed, The combination of secukinumab effectively eliminates the effects of IL-17A, thereby improving the therapeutic efficacy of everolimus in the context of pediatric sarcomas. Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Dec 2023 | Trial primary completion date: Jun 2026 --> Dec 2023
- |||||||||| soticlestat (TAK-935) / Takeda, Xcopri (cenobamate) / SK Bio, Angelini Group, Endo, Fintepla (low-dose fenfluramine) / UCB, Nippon Shinyaku
Retrospective data, Review, Journal: Efficacy and safety of six new antiseizure medications for adjunctive treatment of focal epilepsy and epileptic syndrome: A systematic review and network meta-analysis. (Pubmed Central) - Jan 27, 2024 Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Dec 2023 | Trial primary completion date: Jun 2026 --> Dec 2023 This NMA indicated that the most effective treatment strategy for focal epilepsy, DS, Lennox-Gastaut syndrome, and TSC, respectively, included CBM 300
- |||||||||| everolimus / Generic mfg., mycophenolate mofetil / Generic mfg.
Review, Journal: Post Liver Transplant Renal Dysfunction-Evaluation, Management and Immunosuppressive Practice. (Pubmed Central) - Jan 26, 2024 This NMA indicated that the most effective treatment strategy for focal epilepsy, DS, Lennox-Gastaut syndrome, and TSC, respectively, included CBM 300 Early nephroprotective measures are strongly advised and they mostly center on delaying the administration of calcineurin inhibitors (CNIs) during the initial postoperative period, lowering CNI dosage
- |||||||||| pioglitazone / Generic mfg.
Review, Journal: Peroxisome proliferator-activated receptor?/? agonist pioglitazone for rescuing relapsed or refractory neoplasias by unlocking phenotypic plasticity. (Pubmed Central) - Jan 26, 2024 Pioglitazone, integrated in differentially designed editing schedules, facilitated induction of tumor cell death as indicated by complete remission (CR) in r/r non-PML AML, continuous CR in r/r RCCC, mLCH, and in HL by addition of everolimus, or long-term disease control in melanoma by efficaciously controlling metastasis, post-therapy cancer repopulation and acquired cell-resistance and genetic/molecular-genetic tumor cell heterogeneity (M-CRAC)...Low-dose MCT facilitates targeted reprogramming of cancer hallmarks with transcriptional modulators, induction of tumor cell death, M-CRAC control and editing of non-oncogene addiction. Thus, pioglitazone, integrated in tumor tissue editing protocols, is an important biomodulatory drug for addressing urgent therapeutic problems, such as M-CRAC in relapsed or refractory tumor disease.
- |||||||||| Ostarine (enobosarm) / Veru Inc
Trial completion date, Trial primary completion date, Metastases: ENABLAR-2: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Jan 26, 2024 P3, N=186, Suspended, Thus, pioglitazone, integrated in tumor tissue editing protocols, is an important biomodulatory drug for addressing urgent therapeutic problems, such as M-CRAC in relapsed or refractory tumor disease. Trial completion date: Jan 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Dec 2025
- |||||||||| Inflammatory bowel disease after liver transplantation: a retrospective cohort study from Latin America (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1554;
Regarding immunosuppression, 19 (42.2%) patients were treated with tacrolimus, 10 (22.2%) with tacrolimus and mycophenolate mofetil, 8 (17.7%) with tacrolimus and azathioprine, 3 (6.6%) tacrolimus and everolimus, 3 (6.6%) with mycophenolate mofetil and cyclosporine, 2 (4.4%) patients with cyclosporine monotherapy...After LT, 20 (44.4%) patients required biological therapy, 11 (24.4%) were treated with anti-TNF (infliximab and adalimumab), 5 (11.1%) with vedolizumab, 3 (6.6%) with ustekinumab and 1 with tofacitinib...Eight (17.7%) patients had malignancies, 3 of them related to the baseline conditions such as hepatocellular, gallbladder carcinoma, colorectal cancer, while 4 patients died during the follow-up. Conclusion In our experience, IBD patients undergoing LT exhibited an aggressive disease course and required concomitant biological therapy, despite the ongoing immunosuppressive regimens.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Phase classification, Metastases: CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) - Jan 25, 2024 P1/2, N=12, Active, not recruiting, Active, not recruiting --> Suspended | Trial primary completion date: Sep 2023 --> Jan 2024 Phase classification: P1 --> P1/2
- |||||||||| vepdegestrant (ARV-471) / Arvinas, Pfizer
Enrollment closed, Phase classification, Combination therapy, Metastases: TACTIVE-E: ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer (clinicaltrials.gov) - Jan 22, 2024 P1, N=32, Active, not recruiting, Median number of prior aBC therapies in combination cohorts was: 1 (range 1-2); including prior ET (100%), CDK4/6i (100%), fulvestrant (35%) and chemo (17%). Recruiting --> Active, not recruiting | Phase classification: P1b --> P1
- |||||||||| acarbose / Generic mfg.
Trial completion date, Trial primary completion date, Combination therapy, Immunomodulating, Metastases: Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - Jan 16, 2024 P2, N=24, Not yet recruiting, We identified the most optimal conditions for every step of the process, ensuring pre-analytical sample integrity and robust qPCR results. Trial completion date: Dec 2026 --> Oct 2025 | Trial primary completion date: Jul 2025 --> Oct 2025
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date: Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial (clinicaltrials.gov) - Jan 16, 2024 P2, N=180, Active, not recruiting, Finally, we propose STX4 expression assessment as a novel approach to predict patient response to respective immunotherapies and targeted treatments, hence potentially improving patient outcomes. Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| everolimus / Generic mfg., vinorelbine tartrate / Generic mfg.
Journal: Everolimus Acts in Synergy with Vinorelbine to Suppress the Growth of Hepatocellular Carcinoma. (Pubmed Central) - Jan 15, 2024 The combination of the everolimus and vinorelbine (everolimus/vinorelbine) also promoted apoptosis with minimal toxicity. Given the cost-effectiveness and established effectiveness of everolimus, and especially sirolimus, this strategy warrants further investigation in early-phase clinical trials.
- |||||||||| everolimus / Generic mfg., sirolimus / Generic mfg.
mTor Inhibition: Sirolimus and Everolimus (South Hall 1) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1968; Examines anti-proliferative properties: reviewing dogma and evidence in pediatrics, including the role in CAV preventionand/or treatment.5. Discusses dosing adjustments in patients on concurrent CNI therapy.
- |||||||||| everolimus / Generic mfg., mycophenolate mofetil / Generic mfg.
Pediatric Coronary Angiography in the Teammate Trial: Angiographic Core Interpretation over the First 3 Years Post Transplant (Board #171; Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1863; Findings by treatment assignment will be available at the time of presentation.Conclusion TEAMMATE is the first multi center randomized trial in pediatric HT and evaluated the safety and efficacy of EV/LDT to prevent HT complications. Core lab interpretation showed shorter time to development of CAV than what has been reported to the ISHLT registry, which may be due to increased objectivity with blinded interpretation.
- |||||||||| CABG for Coronary Allograft Vasculopathy - Still a Viable Option? (Board #80; Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1655;
His immunosuppression regimen included cyclosporin and mycophenolate mofetil (MMT)...His immunosuppression regimen included tacrolimus (TAC), everolimus and low dose prednisone...He had no prior CMV infection, however, suffered HBV infection that was treated with Entecavir...Patient underwent LIMA to LAD grafting. Two months later he developed typical angina, significant progression of ostial Cx lesion was diagnosed and PCI was performed.Summary The role of surgical treatment for CAV might be reconsidered due to accelerated progression of coronary disease in both VGs and native vessels.
- |||||||||| everolimus / Generic mfg.
Comparison of Everolimus with Calcineurin Inhibitors in Maintenance Immunosuppression (Board #48; Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1620; Rejection was seen in 14 patients in the calcineurin group after the first year and in 14 in the everolimus group.Conclusion This study suggests that everolimus provides effective immunosuppression with a lower adverse event rate. It can be considered as an alternative treatment option to calcineurin inhibitors after a safe period of wound healing.
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