The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.. Clinical Trials … If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868. These studies test new ways to prevent, detect, diagnose, or treat diseases. Patients who participate with this study will be treated with itacitinib instead of steroids. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. The failure of the Phase 3 study, called GRAVITAS-301, erodes the drug's prospects in acute forms of GvHD and ups the risk of the ongoing trials in other patient groups. Clinical Trials. Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. Clinical Trials / A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With … The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). Placebo Comparator: Placebo. The EU Clinical Trials Register currently displays 39256 clinical trials with a EudraCT protocol, of which 6430 are clinical trials conducted with subjects less than 18 years old. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. On the basis of these results, a phase II clinical trial of itacitinib for the prevention of CRS induced by CD19-CAR T-cell therapy was initiated … Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices. The clinical trials on this list are studying JAK1 Inhibitor INCB039110. Research. Title INCB39110-309: A Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease a study on Graft Versus Host Disease. This trial; Search. Immunotherapy with alemtuzumab, may induce changes in … The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel … Summary Eligibility Home . Patients who participate with this study will be treated with itacitinib instead of steroids. Home . Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form. Myelofibrosis Clinical Trials. Summary Eligibility for people ages 18 years and up (full criteria) All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. A to Z List of Cancer Drugs. All trials Healthy volunteers Pediatric trials. GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease . 200 mg oral for 360 days; Arms, Groups and Cohorts. In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. This phase II trial studies how well itacitinib works in treating patients with low risk graft versus host disease. Patient participation in research studies and clinical trials is critical to understanding IBD and developing new treatments as we work toward a cure. A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis - NCT03144687. Clinical Trials Cancer A Phase II, Single-Arm, Open-label Study of Itacitinib, for the prevention of cytokine Release Syndrome (CRS) … About UC Health Clinical Trials. Itacitinib was discovered at Incyte , and Incyte holds the global development and commercialization rights for itacitinib with the exception of China , where the rights to develop and commercialize itacitinib … Itacitinib is an experimental drug with an excellent safety record and appears to have activity as … Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis Study of the Intestinal Microbiota of Patients With Systemic Sclerosis A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis Autologous Fat Grafting in the … NCT04358185. Vanderbilt Clinical Trials. Itacitinib is a orally administered small molecule Janus kinase 1 (JAK1) inhibitor, being developed by Incyte Corporation for the treatment of cancer, Itacitinib - Incyte Corporation - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript . Drug: Itacitinib. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b … It occurs when donor immune cells (the graft) attack normal tissue in the recipient’s body. Home Clinical Trials and Studies Chronic Graft-Versus-Host Disease Treatment Study Clinical Trial Title GRAVITAS-309: A phase 2/3 study of itacitinib and corticosteroids as initial treatment for chronic graft-versus-host disease: Part 2. A listing of Myelofibrosis medical research trials actively recruiting patient volunteers. Itacitinib Accession Number DB12154 Description. This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. Clinical Trials; Find a Clinical Trial; Toggle navigation Vanderbilt Clinical Trials. Pemigatinib Clinical Trials (fight) Retifanlimab Clinical Trials (POD1UM) Chronic GVHD. Description: This research will assess the effects of Itacitinib as a second line treatment for patients with advanced inflammatory hepatocellular carcinoma (HCC), a type of liver cancer. About the site . **Clinical trials are research studies that involve people. The objective of this study was to assess pharmacokinetics and safety of 300‐mg itacitinib dosed in participants with normal renal function (n = 10), severe renal impairment (n = 8), and end‐stage renal … Clinical trial for Classical Hodgkin Lymphoma , Itacitinib + Everolimus in Hodgkin Lymphoma Reducing the incidence and severity of CRS has the potential to benefit clinical practice, including the use of CAR T-cell therapy in patients in previously high-risk populations. This study provides the rationale for a phase II clinical trial of itacitinib for the prevention of CRS induced by CAR T-cell therapy (NCT04071366). We have numerous clinical trials underway across Oncology and Inflammation & Autoimmunity research areas. Furthermore, itacitinib does not affect CAR T-cell antitumor response in in vivo models. This phase Ib trial studies the side effects and best dose of alemtuzumab when given together with itacitinib in treating patients with T-cell prolymphocytic leukemia. Pre Screen Now Oral placebo everyday for 360 days. Clinical Trial Outcome Measures Primary Measures. Itacitinib is a novel, selective, Janus kinase 1 inhibitor in development for treatment of graft‐versus‐host disease. Incyte-sponsored studies can be found at www.IncyteClinicalTrials.com.. Incyte also supports significant independent research aimed at advancing the study of our products. Experimental: Itacitinib. Clinical Trials / Itacitinib in Advanced Hepatocellular Carcinoma. Itacitinib, which also blocks JAK1, is a large part of that strategy, particularly for expanding into treatment-naive graft-versus-host disease. If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Pemigatinib Clinical Trials (fight) Solid Tumors. Clinical trials are research studies that involve people. Clinical trials look at new ways to prevent, detect, … GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease . Itacitinib is a novel, selective, Janus kinase 1 inhibitor in development for treatment of graft-versus-host disease. About UCSD Clinical Trials. Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. Itacitinib has been used in trials studying the treatment of Melanoma, Carcinoma, Metastatic Cancer, Endometrial Cancer, and B-cell Malignancies, among others. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Graft versus host disease is the most common serious complication after bone marrow transplant. Complementary & Alternative Medicine (CAM) Questions to Ask about Your Treatment. ... Clinical Trials Information. 200 mg oral for 360 days; Drug: Placebo. Change in modified … Why are we doing this research? Data from the ongoing clinical trial program with itacitinib should provide additional evidence about the clinical benefits observed when used earlier in the treatment paradigm. Graft Versus Host Disease Studies . a study on Graft Versus Host Disease. Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. 200mg of oral Itacitinib everyday for 360 days. Itacitinib Phase 2 Trial (39110-211) 8p11 MPN. Search for closest city to find more detailed information on a research study in your area. Type Small Molecule Groups Investigational Structure This trial; Search. Clinical Trial INCB 39110-309: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft Versus Host Disease (GRAVITAS-309) This study is to find out if Itacitinib (INCB039110) (the study drug) in combination with corticosteroids is safe and effective in people who … An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Keywords Lung Cancer non-small cell lung cancer locally advanced metastatic epidermal growth factor receptor (EGFR) inhibition Janus kinase inhibition Lung Neoplasms Carcinoma, Non-Small-Cell Lung Osimertinib Itacitinib Itacitinib + osimertinib Graft Versus Host Disease Studies .