Clinical trials on Graft Versus Host Disease

Graft Versus Host Disease (GVHD) Overview

Graft Versus Host Disease (GVHD) is a significant medical condition that occurs after an allogeneic tissue or organ transplant. In this scenario, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and initiate an immune response against the host’s tissues and organs. This complex interaction can lead to a range of symptoms and affects various parts of the body, including the skin, liver, gastrointestinal tract, and more. GVHD is categorized into two types: acute and chronic, each with distinct clinical features and timelines.

The acute GVHD typically manifests within the first 100 days post-transplant and is characterized by a rapid onset of symptoms such as skin rash, liver dysfunction, and gastrointestinal issues like nausea, vomiting, and diarrhea. On the other hand, chronic GVHD can develop after 100 days and presents more insidiously with symptoms that can include skin changes, dry eyes or mouth, lung dysfunction, and musculoskeletal pain. The management of GVHD involves a multidisciplinary approach, focusing on immunosuppressive medications to reduce the donor immune cells’ activity against the host’s tissues.

Preventive strategies and early intervention are crucial in managing GVHD. The use of prophylactic immunosuppressive drugs post-transplant is a common practice to reduce the risk of developing GVHD. Despite these measures, GVHD remains a challenging complication that can significantly impact the quality of life and overall survival of transplant recipients. Ongoing research and clinical trials are dedicated to finding more effective treatments and understanding the underlying mechanisms of GVHD to improve outcomes for affected individuals.

Prognosis for Graft Versus Host Disease

Graft Versus Host Disease (GVHD) is a condition where donor cells attack the recipient’s body after a transplant. The long-term prospects for individuals with GVHD vary widely and depend on the severity and response to initial treatments. In cases of acute GVHD, which appears shortly after transplantation, the prognosis can range from complete resolution to life-threatening complications. Chronic GVHD, developing later, often presents as a long-term condition that can lead to significant disability, although periods of remission may occur. The overall outlook is better for those who receive prompt and effective management of symptoms, and survival rates have been improving with advances in post-transplant care. However, GVHD remains a serious concern that can impact quality of life and requires careful monitoring and management over time.

Complications in Graft Versus Host Disease

Graft Versus Host Disease (GVHD) can lead to a range of complications that significantly impact health and daily living. Common issues include:

  • Skin problems, such as rashes and thickening, which can cause discomfort and affect appearance.
  • Infections are also more likely because GVHD can weaken the immune system, making it harder to fight off germs.
  • Digestive complications may arise, including nausea, diarrhea, and weight loss, which can make eating and maintaining nutrition challenging.
  • Liver problems can also occur, potentially leading to jaundice, where the skin and eyes turn yellow.
  • Lung complications, such as difficulty breathing and dry cough, can reduce the ability to perform physical activities.
  • Chronic GVHD may result in long-term issues like joint pain or muscle stiffness, hindering movement and daily tasks.

These complications can diminish the quality of life, causing emotional distress, and making it difficult to enjoy activities once taken for granted.

Treatment Methods for Graft Versus Host Disease

For the management of Graft Versus Host Disease (GVHD), several non-clinical trial treatments are often recommended:

  • Dietary adjustments can play a crucial role; a balanced, nutrient-rich diet may support the immune system.
  • Incorporation of physical activity, as tolerated, can also be beneficial for overall health and well-being.
  • Pharmacotherapy options typically include medications that suppress the immune system to reduce the severity of GVHD symptoms. These may involve corticosteroids or other immunosuppressive agents, which should be used under the guidance of healthcare professionals.
  • Modern technology offers additional support, such as photopheresis, where blood is treated with light to modulate the immune response, potentially alleviating symptoms.

Consultation with healthcare providers is important to determine the most appropriate treatment strategy based on individual needs and the specifics of the condition.

  • CT-EU-00053467

    Studying effects of ruxolitinib and panobinostat on myelofibrosis and polycythemia vera

    This is a study to check the long-term safety of two drugs – Ruxolitinib alone or Ruxolitinib combined with Panobinostat. In that trial, patients can take part if they’ve previously been involved in a study by Novartis or Incyte, and the treatment was beneficial. All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study. Researchers will look at participant’s general health and well-being. They’ll also note down any side effects or health problems that appear during taking the drugs.

    • panobinostat
    • Ruxolitinib
  • Exploring the effectiveness of Itolizumab in enhancing Acute Graft Versus Host Disease treatment with corticosteroids

    This trial examines Itolizumab, combined with corticosteroids, for treating Acute Graft Versus Host Disease (aGVHD). It’s designed to test the safety and effectiveness of Itolizumab in comparison to a placebo. Participants receive the treatment through IV every two weeks, with a total of 7 doses. The study involves 200 participants across various sites and tracks their health for about a year to see how well Itolizumab works against aGVHD when taken alongside standard corticosteroids.

    • Itolizumab/EQ001
  • Examining new treatment for digestive complications of Graft Versus Host Disease

    This study is examining the effects of a therapy called MaaT013 in patients who do not respond well to a drug called Ruxolitinib. Patients suffer from a disease called acute GVHD that affects their stomach. Previous studies have shown promising results, with most patients showing improvement after receiving MaaT013. Due to these results, MaaT013 will be used as “rescue therapy” in patients who do not improve with steroids or JAK inhibitors, drugs often used to treat the disease. The standard first treatment for acute GVHD is steroids, but some patients do not respond well to this treatment, and those who do may have serious side effects if they take high doses for a long time. Therefore, scientists are interested in exploring alternative treatments such as MaaT013. A drug called Ruxolitinib was approved by the FDA in 2019, but again, not all patients respond well to this treatment, prompting the need to develop alternatives.

    • MaaT013- new potential medication for gastrointestinal acute graft-versus-host disease
  • Investigating new therapies for high-risk acute graft-versus-host disease with uvadex

    The project is an innovative study targeting an improved treatment for patients with high-risk acute graft-versus-host disease (GVHD). The study aims to enhance patient outcomes in terms of response to therapy and associated mortality. This trial focuses on patients with high-risk acute GVHD, specifically those with an Ann Arbor score 2 or 3. The treatment procedure employs Extracorporal Photopheresis with UVADEX coupled with standard steroid treatment, expected to deliver a complete response rate of above or equal to 52% on the 28th day. This significantly betters the standard care response by 15%. Patient treatment endures for approximately 8 weeks and tracking for a year to assess long-term effects.

    • Uvadex