Ongoing Clinical Trials for Acute Graft Versus Host Disease In Intestine
There are currently 3 clinical trials underway for acute graft versus host disease affecting the intestine. These studies are being conducted across multiple European countries and are testing different treatment approaches for patients who have undergone stem cell or organ transplantation and are experiencing complications related to the immune system attacking their gastrointestinal tract or other organs.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
- Sweden
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study is examining whether using a single medication approach works better than combining three medications for older patients who have received a kidney transplant. The focus is on reducing infections while preventing the body from rejecting the transplanted kidney.
Who can participate: This trial is open to patients who are 60 years of age or older and are receiving either a kidney transplant from a deceased donor or a living donor. 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 requirements. Both men and women are eligible. Participants must be able to understand and sign a written informed consent document.
Who cannot participate: Patients below 18 years or above 65 years of age cannot participate. Those who have had previous organ transplants other than the current kidney transplant are excluded. Patients with active or chronic infections, current pregnancy or breastfeeding, known allergies to immunosuppressive medications, severe heart, liver, or lung disease, active cancer or history of cancer in the past 5 years, uncontrolled diabetes, mental conditions affecting their ability to follow study procedures, or participation in other clinical trials within the past 30 days are not eligible. Additionally, those with a history of substance abuse within the past 2 years, inability to provide informed consent, severe kidney dysfunction despite transplantation, history of organ rejection episodes in the past 6 months, or unstable medical conditions are excluded.
What the study focuses on: The trial compares using tacrolimus alone versus the standard combination of three immunosuppressive medications in elderly kidney transplant recipients. The goal is to reduce infection-related complications while maintaining adequate protection against organ rejection. Participants will be followed for three years after their kidney transplant, during which researchers will monitor the occurrence of infections, the function of the transplanted kidney, and overall quality of life through regular medical tests.
Medications being tested: The study compares tacrolimus as a single medication against the standard triple therapy combination. Tacrolimus is an immunosuppressive medication that helps prevent organ rejection by weakening the immune system’s response to the transplanted kidney. The standard triple therapy includes tacrolimus combined with mycophenolate mofetil and prednisone, which are additional immune-suppressing medications. 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 trial focuses on monitoring the long-term safety of treatments for patients who have previously participated in studies involving ruxolitinib, either alone or combined with other medications. The study gathers information on the safety of these treatments over an extended period.
Who can participate: 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 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. It 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 are excluded. Those who are not part of the clinical trial group specified for this study cannot participate.
What the study focuses on: The main objective is to evaluate long-term safety data, focusing on any serious adverse events or other side effects. The study monitors the frequency and severity of these events throughout the treatment period. Researchers will assess the clinical benefits of the treatment during scheduled visits, helping determine the proportion of patients experiencing positive outcomes. The study is expected to continue until September 2027.
Medications being tested: Ruxolitinib is used to treat certain types of blood disorders by reducing symptoms such as enlarged spleen. Panobinostat is often used in combination with other treatments to help manage certain types of cancer by slowing down cancer cell growth. Siremadlin is being studied for its potential to treat cancer by targeting specific pathways that cancer cells use to grow. Rineterkib is being investigated for its ability to interfere with the processes that allow cancer cells to multiply and spread. All medications are administered orally.
Study on MaaT013 for Treating Acute Gastrointestinal Graft-Versus-Host Disease in Patients Not Responding to Ruxolitinib
This clinical trial is studying a condition called acute graft-versus-host disease that affects the gastrointestinal tract. This condition can occur in patients who have undergone a stem cell transplant and involves the donor cells attacking the patient’s body, particularly the digestive system. The trial specifically targets patients whose condition is resistant or intolerant to a medication called ruxolitinib.
Who can participate: Patients must be 18 years old or older and have had an allogeneic stem cell transplant from a donor. They must have an acute graft-versus-host disease episode affecting the gastrointestinal tract and must be resistant to steroids and either resistant to or intolerant of ruxolitinib. Participants must sign an informed and written consent form, or have it signed by a legally acceptable representative if under guardianship or trusteeship.
Who cannot participate: Patients who have a different type of illness not related to the treatment of acute graft-versus-host disease affecting the gastrointestinal tract are excluded. Those who are not resistant or intolerant to ruxolitinib, not within the specified age range, or not part of the specified clinical trial group cannot participate.
What the study focuses on: The study evaluates how effective MaaT013 is in treating acute graft-versus-host disease in the gastrointestinal tract. Participants receive the treatment over a period of 28 days, with the primary evaluation occurring at day 28 and further assessments at day 56 and month 3. The study monitors the response of the disease to treatment and assesses how well it works in reducing symptoms and improving patients’ quality of life. Researchers also track the duration of response and any changes in patients’ condition over time.
Medications being tested: MaaT013 is a rectal solution containing a mixture of healthy bacteria from donor stool, known as allogeneic fecal microbiota. It is administered as an enema, targeting the gastrointestinal tract directly. This microbiome therapeutic works by restoring the balance of gut bacteria, which is believed to help moderate the immune response and reduce inflammation. It is being tested as a salvage therapy for patients who have not responded to other treatments like ruxolitinib.
Summary
The three clinical trials for acute graft versus host disease in the intestine represent diverse approaches to managing complications following transplantation. Two of the three trials specifically address graft-versus-host disease, while the third focuses on kidney transplant patients, reflecting the broader spectrum of transplant-related complications.
Geographically, the trials show a strong concentration in European countries, with Germany and Italy participating in two trials each. The MaaT013 study has the widest geographic reach, being conducted across six European countries including Spain, France, Italy, Germany, Belgium, and Austria. The ruxolitinib long-term safety study is being conducted in Sweden, Poland, Germany, and Italy, while the kidney transplant study is limited to the Netherlands.
An interesting observation is the focus on patients who have already tried standard treatments and need alternative options. The MaaT013 trial specifically targets patients who are resistant or intolerant to ruxolitinib, representing an important option for those who have exhausted first-line therapies. The long-term safety study follows patients who are already benefiting from ruxolitinib-based treatments, providing valuable data on extended use of these medications.
The approaches being tested vary significantly, from traditional immunosuppressive medications in the kidney transplant study to innovative microbiome-based therapies in the MaaT013 trial. This diversity reflects ongoing efforts to find safer and more effective treatments for transplant patients, particularly those in vulnerable populations such as the elderly or those with treatment-resistant disease.
