In short
This article provides information about 2 ongoing clinical trials related to Chronic Graft Versus Host Disease In Liver. These studies are investigating different treatment approaches for patients who have received organ transplants, focusing on medication regimens and long-term safety monitoring. Trials are currently being conducted across several European countries including Germany, Italy, Netherlands, Poland, and Sweden.
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 trial is being conducted in the Netherlands and focuses on elderly patients who have received a kidney transplant. The study compares two different approaches to preventing organ rejection: using tacrolimus alone or combining it with two additional medications, mycophenolate mofetil and prednisone.
Main inclusion criteria: Patients must be 60 years of age or older and receiving either a deceased donor or living donor kidney transplant. They must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients can participate if they meet all other requirements. Both men and women are eligible, and patients must be able to understand and sign an informed consent document.
Main exclusion criteria: Patients outside the age range of 18 to 65 years cannot participate. Those with previous organ transplants other than the current kidney transplant, active or chronic infections, current pregnancy or breastfeeding, or known allergies to immunosuppressive medications are excluded. Additional exclusion criteria include severe heart, liver, or lung disease, active cancer or cancer history in the past 5 years, uncontrolled diabetes, mental conditions affecting study participation, recent participation in other trials, substance abuse history within 2 years, and inability to provide informed consent.
Focus and goal: The study aims to determine 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 through regular medical tests. The study will track complications and assess how well the transplanted kidney is working throughout the follow-up period.
Investigational drugs: The primary medication being studied is tacrolimus, an immunosuppressive drug that helps prevent the body from rejecting the transplanted kidney by weakening the immune system's response. The comparison group receives standard triple therapy, which combines tacrolimus with mycophenolate mofetil (which also prevents organ rejection) and prednisone (a steroid that reduces inflammation and suppresses the immune system). All medications are taken by mouth daily.
Study on Long-Term Safety of Ruxolitinib, Panobinostat, and Siremadlin for Patients Continuing Treatment from Previous Studies
This multi-center 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 medications.
Main inclusion criteria: Patients must currently be enrolled in a study sponsored by Novartis or Incyte and receiving treatment with ruxolitinib alone or in combination with panobinostat, siremadlin, or rineterkib. They must have met all requirements of their original study and 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, and may include vulnerable populations requiring special protection or care.
Main exclusion criteria: Patients who are not within the specified age range for the study or do not meet the specific disease criteria outlined in the parent protocol are excluded. Those who are not part of the clinical trial group specified for this study or are considered part of a vulnerable population that might need special protection or care are also excluded.
Focus and goal: The primary purpose of this study is to gather information on the long-term safety of ruxolitinib and its combinations over an extended period. Participants will continue their treatment 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 treatment. Regular scheduled visits will allow investigators to assess the clinical benefits patients experience from continued treatment. The study is expected to continue until September 2027.
Investigational drugs: Ruxolitinib is a medication used to treat certain types of blood disorders and is the main drug being studied. It may be combined with panobinostat, a medication often used to help manage certain types of cancer by slowing or stopping cancer cell growth; siremadlin, which is being studied for its potential to treat cancer by targeting specific pathways cancer cells use to grow; or rineterkib, which is being investigated for its ability to interfere with cancer cell multiplication and spread. All medications are administered orally in the form of capsules or tablets.
Summary
The two clinical trials described in this article represent different approaches to managing complications related to organ transplantation and blood disorders. The first trial, conducted in the Netherlands, specifically addresses the needs of elderly kidney transplant recipients by exploring whether simplified medication regimens can reduce infection risks while maintaining adequate protection against organ rejection. This study reflects growing interest in personalized medicine approaches for older patients who may be more vulnerable to medication side effects.
The second trial, conducted across multiple European countries including Sweden, Poland, Germany, and Italy, takes a different approach by focusing on long-term safety monitoring for patients who have already shown benefit from ruxolitinib-based treatments. This continuation study is particularly important for understanding the extended safety profile of these medications, especially when used in combination therapies. The international scope of this trial allows for a more diverse patient population and potentially more robust safety data.
Both studies emphasize patient safety as a primary concern, with careful monitoring protocols and specific inclusion and exclusion criteria designed to protect participants while gathering valuable medical information. Patients interested in participating should discuss these opportunities with their healthcare providers to determine if they meet the eligibility requirements.
