Ongoing Clinical Trials for Chronic Graft Versus Host Disease In Intestine
This article provides information about 2 ongoing clinical trials for chronic graft versus host disease in the intestine. These studies are exploring different treatment approaches to improve outcomes for patients who have undergone transplantation and are experiencing complications related to immune system responses.
Clinical trial locations
- Germany
- Italy
- Netherlands
- Poland
- Sweden
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study is taking place in the Netherlands and focuses on elderly patients who have received a kidney transplant. The research aims to determine whether using a single medication approach with tacrolimus alone works better than the standard treatment that combines three different medications.
Main focus: The trial examines whether using fewer medications can reduce the risk of infections and improve quality of life in older transplant recipients. Researchers will follow participants for three years after their kidney transplant, monitoring the occurrence of infections, kidney function, and overall patient well-being.
Who can participate: The study accepts patients who are 60 years of age or older and are receiving either a deceased donor or living donor kidney transplant. Patients must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients can participate if they meet all other criteria. Both men and women can join the study, and patients must be able to understand and sign a written informed consent document.
Who cannot participate: The study excludes patients younger than 18 years or older than 65 years, those with previous organ transplants other than the current kidney transplant, and individuals with active or chronic infections. Women who are pregnant or breastfeeding cannot participate. Additionally, patients with known allergies to immunosuppressive medications, severe heart, liver, or lung disease, active cancer or cancer history in the past 5 years, uncontrolled diabetes, or severe kidney dysfunction despite transplantation are excluded. Other exclusion factors include mental conditions affecting the ability to follow study procedures, participation in other clinical trials within the past 30 days, history of substance abuse within the past 2 years, history of organ rejection episodes in the past 6 months, and unstable medical conditions.
Investigational drugs: The study tests tacrolimus as a single-drug therapy approach. Tacrolimus is an immunosuppressive medication that helps prevent organ rejection after kidney transplantation by weakening the immune system’s response to the transplanted kidney. The trial compares using tacrolimus alone versus the standard combination of three immunosuppressive medications, including mycophenolate mofetil and prednisone, in elderly kidney transplant recipients. The goal is to reduce infection-related complications while maintaining adequate protection against organ rejection.
Study on Long-Term Safety of Ruxolitinib, Panobinostat, and Siremadlin for Patients Continuing Treatment from Previous Studies
This clinical trial is being conducted in Sweden, Poland, Germany, and Italy. It focuses on evaluating the long-term safety of treatments for patients who have previously participated in studies involving ruxolitinib, either alone or in combination with other drugs.
Main focus: The purpose of the study is to gather information on the safety of these treatments over a longer period. Participants will continue their treatment with ruxolitinib or its combinations as they have been doing in their previous studies. The study will monitor the frequency and severity of any side effects or adverse events that occur during the treatment. This open-label, multi-center study aims to provide valuable data on the long-term safety of these medications and their combinations.
Who can participate: Patients must be currently enrolled in a study sponsored by Novartis or Incyte and receiving treatment with ruxolitinib alone or in combination with other medicines like panobinostat, siremadlin, or rineterkib. Patients must have met all the requirements of the original study they are part of and must be benefiting from the treatment as determined by the investigator. The study accepts both male and female patients from different age groups, including children, teenagers, and adults. The study may include vulnerable populations who need special protection or care.
Who cannot participate: Patients who are not within the specified age range for the study or who do not meet the specific disease criteria outlined in the parent protocol cannot participate. Patients who are not part of the clinical trial group specified for this study are also excluded.
Investigational drugs: The trial involves several medications. Ruxolitinib is used to treat certain types of blood disorders by inhibiting Janus kinase enzymes, which play a role in the signaling pathways that control blood cell production. Panobinostat is often used in combination with other treatments to help manage certain types of cancer by inhibiting histone deacetylases, affecting gene expression and cancer cell death. Siremadlin works by inhibiting the MDM2 protein, which can lead to the activation of the p53 tumor suppressor pathway, promoting cancer cell death. Rineterkib functions by inhibiting specific signaling pathways involved in cancer cell growth and survival. All medications are administered orally in tablet or capsule form.
Summary
There are currently 2 ongoing clinical trials related to chronic graft versus host disease in the intestine. These studies are taking place across multiple European countries, with trials in the Netherlands, Sweden, Poland, Germany, and Italy. The trials explore different treatment approaches, from immunosuppressive therapies in kidney transplant recipients to long-term safety evaluations of medications for blood disorders and cancer.
One notable observation is that one trial focuses specifically on elderly kidney transplant patients in the Netherlands, examining whether simpler medication regimens can reduce infection risks while maintaining transplant success. The other trial, spanning four countries, represents a continuation study for patients already benefiting from previous treatments with ruxolitinib and related medications, emphasizing the importance of long-term safety monitoring.
These trials demonstrate the ongoing efforts to optimize treatment approaches for patients experiencing complications related to transplantation and immune system disorders. Both studies emphasize patient safety and quality of life as key outcomes, reflecting a patient-centered approach to clinical research.
