Ongoing Clinical Trials for Acute Graft Versus Host Disease in Liver
Currently, there are 2 ongoing clinical trials investigating treatments for patients with conditions related to transplantation and blood disorders. These studies are being conducted across several European countries including Germany, Italy, Netherlands, Poland, and Sweden. The trials focus on improving treatment outcomes through different medication approaches, including single-drug therapy versus combination treatments, and long-term safety monitoring of established medications.
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 being conducted in the Netherlands and focuses on elderly patients who have recently received a kidney transplant. The main goal is to determine whether a simpler treatment approach using only one medication might work better for older transplant recipients compared to the standard three-drug combination.
Who can participate: The trial is designed for patients who are 60 years of age or older and are receiving either a kidney from a deceased donor or a living donor. Participants must not have donor-specific anti-HLA antibodies at the time of transplantation. Both men and women can join the study, and even those who have had a previous kidney transplant may be eligible if they meet all other requirements. Patients must be able to understand and provide written informed consent.
Who cannot participate: The study excludes people who are outside the age range of 18 to 65 years, those with previous organ transplants other than the current kidney transplant, and individuals with active or chronic infections. Pregnant or breastfeeding women cannot participate. Other exclusion criteria include known allergies to immunosuppressive medications, severe heart, liver or lung disease, active cancer or cancer history within the past five years, uncontrolled diabetes, mental conditions affecting study compliance, recent participation in other clinical trials, and substance abuse history within the past two years.
What the trial is testing: The study compares two different approaches to preventing organ rejection. One approach uses tacrolimus as a single medication, while the other uses the traditional combination of three medications: tacrolimus, mycophenolate mofetil, and prednisone. Tacrolimus works by suppressing the immune system to prevent the body from rejecting the transplanted kidney. The combination therapy includes mycophenolate mofetil, which also helps prevent organ rejection, and prednisone, a steroid that reduces inflammation and suppresses the immune system.
Study focus: Researchers will follow participants for three years after their transplant to monitor the occurrence of infections, kidney function, and overall quality of life. The main objective is to determine if using fewer medications can reduce infection risks while still effectively protecting against organ rejection. Regular blood tests will check kidney function and monitor for viral infections such as cytomegalovirus and BK-virus, which can be particularly problematic in transplant patients taking immune-suppressing medications.
Study on Long-Term Safety of Ruxolitinib, Panobinostat, and Siremadlin for Patients Continuing Treatment from Previous Studies
This clinical trial is taking place across four European countries: Sweden, Poland, Germany, and Italy. It is designed for patients who have already participated in previous research studies and are continuing to benefit from their current treatment.
Who can participate: This study is open to patients who are currently enrolled in a research study sponsored by Novartis or Incyte and are receiving treatment with ruxolitinib, either alone or in combination with other medications such as panobinostat, siremadlin, or rineterkib. To be eligible, patients must have met all requirements of their original study and must be experiencing clinical benefit from their treatment as determined by their doctor. The study accepts both male and female patients across different age groups, including children, teenagers, and adults.
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 join. The trial is limited to those who are part of the specified clinical trial group and have been previously enrolled in qualifying studies.
What the trial is testing: The study involves several medications used to treat blood disorders and certain types of cancer. Ruxolitinib is a medication that works by blocking certain enzymes involved in blood cell production and is used to treat conditions affecting blood and bone marrow. Panobinostat is often used in combination treatments to help manage certain cancers by slowing down cancer cell growth. Siremadlin and rineterkib are investigational medications being studied for their potential to treat cancer by targeting specific pathways that cancer cells use to grow and survive.
Study focus: The main purpose of this trial is to gather long-term safety information about these medications. Researchers will monitor the frequency and severity of any side effects or adverse events that occur during continued treatment. Patients will attend scheduled visits where doctors will assess whether they continue to benefit from their treatment. All medications in this study are taken orally as capsules or tablets. The study is expected to continue until September 2027, and patients will remain enrolled as long as they continue to benefit from their treatment and meet study requirements.
Summary
These two clinical trials represent different approaches to understanding and improving transplant-related treatments. The first study focuses specifically on elderly kidney transplant recipients in the Netherlands and seeks to simplify treatment regimens while reducing infection risks. This research is particularly important given the vulnerability of older patients to both infections and medication side effects.
The second trial takes a broader geographical approach, spanning four European countries, and focuses on long-term safety monitoring for patients already benefiting from treatment with ruxolitinib and related medications. This study provides valuable continuation options for patients who have responded well to these treatments in previous trials.
Both trials emphasize patient safety and quality of life as key outcomes. The kidney transplant study will run for three years per participant, while the safety monitoring study is planned to continue until 2027, demonstrating the commitment to long-term follow-up and comprehensive safety data collection.
