Ongoing Clinical Trials for Graft Versus Host Disease
This article provides detailed information about 7 ongoing clinical trials investigating treatments and prevention strategies for Graft Versus Host Disease, a condition that can occur after stem cell or bone marrow transplantation. These trials are being conducted across multiple European countries and test various approaches including cell therapies, immunosuppressive medications, and novel biological agents.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Germany
- Comparison of Post-Transplant Cyclophosphamide versus Anti-T Lymphocyte Immunoglobulin for Prevention of Graft versus Host Disease in Patients Receiving Unrelated Donor Transplantation
- Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
- Study on the Safety and Effectiveness of Human Alpha1-Proteinase Inhibitor for Preventing Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Cell Transplant.
- Greece
- Hungary
- Italy
- Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions
- Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
- Study on the Safety and Effectiveness of Human Alpha1-Proteinase Inhibitor for Preventing Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Cell Transplant.
- Netherlands
- Norway
- Poland
- Portugal
- Spain
- Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions
- Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
- Study on the Safety and Effectiveness of Human Alpha1-Proteinase Inhibitor for Preventing Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Cell Transplant.
- Sweden
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study is designed for elderly patients aged 60 years or older who are receiving a kidney transplant. Participants can receive either a deceased or living donor kidney, but they must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients are allowed to participate if they meet all other criteria. Both men and women can join the study, and participants must be able to understand and sign an informed consent document.
The trial excludes patients younger than 18 or older than 65 years, those with previous organ transplants other than kidney, active or chronic infections, current pregnancy or breastfeeding, known allergies to immunosuppressive medications, and severe heart, liver, or lung disease. Additional exclusion criteria include active cancer or recent cancer history, uncontrolled diabetes, mental conditions affecting study compliance, recent participation in other clinical trials, and substance abuse history.
The main focus of this research is to determine whether using tacrolimus alone works better than combining three medications in reducing infection risks among elderly transplant recipients. The study follows participants for three years after transplantation, monitoring infection occurrence, kidney function, and overall quality of life through regular medical tests and assessments.
The investigational approach compares tacrolimus as a single-drug therapy against standard triple immunosuppressive therapy. Tacrolimus is an immunosuppressive medication that helps prevent organ rejection by weakening the immune system’s response to the transplanted kidney. The standard approach combines tacrolimus with mycophenolate mofetil and prednisone.
Study of iG-Tregs for Preventing Graft-versus-Host Disease in Adults Undergoing HLA-Matched Sibling Stem Cell Transplantation
This trial focuses on patients undergoing HLA-matched sibling donor allogeneic hematopoietic cell transplantation for blood-related cancers. Participants must have a fully compatible sibling donor and maintain a Karnofsky performance status of 60% or higher. Adequate blood and organ function is required, including specific measurements of neutrophil count, kidney function, liver enzymes, and heart function. The study requires continuous cyclosporine treatment at therapeutic levels starting three days before transplantation.
Patients who are not adults, those not receiving stem cell transplantation from a fully compatible sibling donor, or those not receiving treatment to prevent or treat the condition are excluded. The study also excludes individuals considered part of vulnerable populations.
The study investigates inducible HLAG+ Regulatory T Cells given through injection to help prevent the condition after transplant. The research aims to determine the safest dose of these special cells and evaluate their safety and effectiveness when used in patients who have received a transplant from a fully compatible sibling donor. Participants receive the cell infusion and are monitored for any side effects or reactions, with follow-up lasting up to 52 weeks.
The investigational treatment involves iG-Tregs, a type of cell therapy taken from a donor who is a perfect match for the patient. These cells are designed to help prevent acute complications by modulating the immune response to reduce the risk, leveraging their regulatory function to maintain immune balance.
Study on the Safety of Decidua Stromal Cells for Patients with Steroid-Resistant Severe Acute Graft vs Host Disease
This study focuses on patients with severe acute complications following stem cell transplant that do not respond to standard steroid treatments. Participants must be 18 years old or older and have undergone a specific type of stem cell transplant. A clinical diagnosis of steroid-resistant disease is required, meaning the condition does not improve with high doses of steroids or worsens despite treatment.
Exclusion criteria include patients not within the specified age range and those considered part of vulnerable populations. The study also excludes individuals with the condition but who do not meet other specific criteria.
The treatment being tested involves Decidua Stromal Cells, which are derived from the placenta and expanded outside the body. Three different formulations will be compared to the best available treatment options. Participants receive treatment through intravenous infusion, and the study monitors response at 28 days and 56 days after starting treatment, tracking side effects, complications, and overall survival.
The investigational approach compares Decidua Stromal Cells against the best available treatment. These cells work by modulating the immune response, potentially reducing inflammation and tissue damage. The study measures various outcomes including the proportion of patients achieving complete or partial response by day 28 and maintaining it by day 56.
Comparison of Post-Transplant Cyclophosphamide versus Anti-T Lymphocyte Immunoglobulin for Prevention of Graft versus Host Disease in Patients Receiving Unrelated Donor Transplantation
This study involves patients at least 18 years old with conditions including Acute Myeloid Leukemia in first complete remission with intermediate or high-risk features, relapsed or refractory disease, Myelodysplastic Syndrome with intermediate to very high-risk features, or related conditions. Participants must have adequate heart function and be scheduled to receive peripheral blood stem cells from an unrelated donor whose tissue type matches with no more than one mismatch.
The study excludes patients younger than 18 or older than 65, those who are pregnant or breastfeeding, individuals with previous stem cell transplantation, active uncontrolled infections, severe organ dysfunction, active psychiatric disorders, known allergies to study medications, recent participation in other trials, HIV positive status, active hepatitis infections, inability to provide informed consent, cancer spread to the central nervous system, or poor performance status.
The research compares two different approaches to prevent complications after stem cell transplantation from an unrelated donor. The study uses several medications including cyclophosphamide, mycophenolate mofetil, and tacrolimus. One group receives Grafalon containing antibodies affecting the immune system, while another group receives a different medication combination. Treatment is given around the time of transplantation, with specific schedules lasting from days to months.
The investigational drugs include post-transplant cyclophosphamide, which suppresses the immune system to prevent donated cells from attacking the recipient’s body, and anti-thymocyte globulin, an antibody medication that targets T-cells to reduce the risk of complications.
Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions
This study provides extended treatment for individuals who previously participated in ibrutinib clinical trials and continue to benefit from its use. Participants must have been in a previous ibrutinib trial, benefit from continuing or restarting treatment according to their doctor, not have access to commercial ibrutinib in their region, have completed all necessary evaluations in their previous study, and wish to continue treatment. Both males and females who can have children must agree to use effective birth control methods.
The study excludes patients with certain types of cancer who do not meet age requirements, are not part of specified clinical trial groups, are not eligible for long-term access to the medication, or are considered part of vulnerable populations.
The purpose is to allow patients who showed positive results from previous trials to continue receiving ibrutinib, even if it is not commercially available in their region. Participants continue taking ibrutinib in hard capsule form taken orally, with monitoring for long-term effects and potential side effects, specifically serious adverse events.
Ibrutinib is a targeted therapy medication that interferes with the growth and spread of cancer cells by inhibiting Bruton’s tyrosine kinase, a protein crucial for the survival and spread of cancer cells. This trial provides long-term treatment for patients who previously benefited from the medication in earlier studies.
Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
This study focuses on treating complications occurring after bone marrow transplants. Participants must be at least 12 years old and weigh more than 40 kg. They must have received an initial allogeneic stem cell transplant and show signs of successful stem cell growth with adequate neutrophil count. A diagnosis of severe or moderate disease with digestive tract involvement is required. Participants must have started corticosteroid treatment at appropriate doses within 72 hours before starting the study medication.
The trial excludes patients with previous treatment with investigational drugs within 30 days, history of allergic reactions to similar medications, active uncontrolled infections, severe organ problems, uncontrolled heart conditions, active cancer other than the treated condition, pregnancy or breastfeeding, inability to follow study procedures, mental conditions preventing understanding, or current participation in other trials.
The research evaluates itolizumab used together with corticosteroids as an initial treatment. The study tests whether adding itolizumab to corticosteroid treatment works better than adding placebo. The medication is given through intravenous infusion over 84 days, with dosing based on patient weight. The study uses methods ensuring neither doctors nor patients know which treatment each person receives. The main goal is to assess early-stage response to treatment.
Itolizumab is a monoclonal antibody medication targeting specific proteins in the immune system to help reduce inflammation and control immune response. It is being studied in combination with corticosteroids, anti-inflammatory medications that help suppress the immune system and manage symptoms.
Study on the Safety and Effectiveness of Human Alpha1-Proteinase Inhibitor for Preventing Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Cell Transplant.
This trial focuses on patients undergoing hematopoietic cell transplant. Participants can be male or female and must be at least 12 years old, though in Germany the minimum age is 18. They should be undergoing transplantation for specific blood-related cancers including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. A planned myeloablative conditioning regimen is required before transplant.
The study excludes patients with a different medical condition than the one being studied, those not within the specified age range, individuals not part of the specific clinical trial group, patients not of the included genders, and those considered part of vulnerable populations.
The research tests Alpha-1 Antitrypsin treatment for preventing complications after transplant. The treatment uses Respreeza, a powder and solvent mixed to form a solution for infusion into the bloodstream. Participants receive either the treatment or placebo, with follow-up monitoring for signs of complications, side effects, and other health changes. The study will monitor patients for up to 180 days for the development of severe complications and for up to 730 days for long-term outcomes.
Alpha-1 Antitrypsin is a protein that may help reduce inflammation and protect tissues. The medication works by inhibiting enzymes that can cause tissue damage, thereby reducing inflammation and immune response, potentially preventing complications after transplant.
Summary
These seven ongoing clinical trials represent diverse approaches to preventing and treating complications following transplantation. The trials are spread across multiple European countries, with notable concentration in countries like Germany, Spain, Italy, and France, reflecting strong research infrastructure in these regions.
Several trials focus on prevention strategies using different immunosuppressive approaches, including novel cell therapies like iG-Tregs and Decidua Stromal Cells, as well as established medications in new combinations. Other studies investigate treatment options for patients whose condition does not respond to standard steroid therapy, representing an important area of unmet medical need.
The research includes both early-phase studies testing safety and optimal dosing of new treatments, and later-phase trials comparing different medication strategies. Many trials focus specifically on patients receiving transplants from unrelated or sibling donors, addressing the particular challenges these patients face. The studies collectively aim to improve outcomes for transplant recipients by reducing complications, improving quality of life, and enhancing long-term survival.
