Ongoing Clinical Trials for Allogenic Stem Cell Transplantation
This article provides information about 6 ongoing clinical trials investigating treatments and preventive measures for complications related to allogenic stem cell transplantation. These studies focus on managing conditions such as acute graft-versus-host disease, improving immune system recovery, preventing infections, and optimizing vaccination timing after transplantation.
Clinical trial locations
- Belgium
- France
- Study Comparing Methylprednisolone and Methoxsalen for Treating Grade II Acute Graft-Versus-Host Disease in Adult Stem Cell Transplant Patients
- Study on MaaT033 to Prevent Complications in Patients with Blood Cancer Undergoing Stem Cell Transplantation
- Study on the Safety and Effectiveness of SMART101 for Patients Undergoing Stem Cell Transplantation for Blood Cancers
- Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
- Germany
- Italy
- Netherlands
- Portugal
- Spain
- Study on MaaT033 to Prevent Complications in Patients with Blood Cancer Undergoing Stem Cell Transplantation
- Study Comparing Fosfomycin and Ciprofloxacin for Preventing Fever in Patients with Acute Leukemia After Chemotherapy or Stem Cell Transplant
- Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
- Sweden
Study Comparing Methylprednisolone and Methoxsalen for Treating Grade II Acute Graft-Versus-Host Disease in Adult Stem Cell Transplant Patients
This trial, conducted in France, investigates treatment approaches for Grade II acute graft-versus-host disease, a condition where transplanted donor cells attack the recipient’s body, typically affecting the skin and upper digestive system. The study compares two treatment strategies: corticosteroids alone versus corticosteroids combined with extracorporeal photopheresis, a procedure where blood is treated outside the body.
Inclusion criteria: Participants must be adults over 18 who have received an allogeneic stem cell transplant and developed Grade II acute graft-versus-host disease within 3 months after transplantation. They must need first-line treatment and have adequate blood cell counts, including white blood cells greater than 1.5 G/L and platelets greater than 30 G/L. Suitable venous access for weekly treatment sessions is required.
Exclusion criteria: The study excludes individuals under 18, those not receiving allogeneic stem cell transplantation, patients without Grade II acute graft-versus-host disease affecting the skin or upper digestive system, and those not treated in participating transplant centers.
Study focus: The trial aims to determine which treatment approach better prevents treatment failure over six months. Participants are randomly assigned to receive either corticosteroids alone or corticosteroids with extracorporeal photopheresis. The study monitors disease progression, quality of life, and any complications throughout the treatment period.
Investigational drugs: The study uses corticosteroids including methylprednisolone and prednisone to reduce inflammation and suppress the immune system. For the experimental group, methoxsalen is used with extracorporeal photopheresis to modify the immune response. Additional medications like posaconazole may also be part of the treatment protocol.
Study on HPV Vaccine Timing for Patients After Stem Cell Transplantation Using Gardasil 9
This Swedish trial examines the optimal timing for HPV vaccination in adults who have undergone allogeneic stem cell transplantation. The study compares immune responses when Gardasil 9 vaccine is given starting at 9 months versus 15 months after transplantation.
Inclusion criteria: Adults aged 18 to 45 who have received an allogeneic stem cell transplant from either related or unrelated donors are eligible. Previous HPV vaccination status does not affect eligibility.
Exclusion criteria: The trial excludes those who have not received an allogeneic stem cell transplantation.
Study focus: Participants receive three doses of Gardasil 9 vaccine according to their assigned schedule, with the second dose two months after the first and the third dose six months after the first. Researchers measure antibody levels against HPV at one month and 12 months after the final dose to evaluate immune protection.
Investigational drugs: Gardasil 9 is a vaccine protecting against nine types of human papillomavirus. The study investigates whether earlier or later vaccination after transplantation provides better immune protection against HPV-related diseases.
Study on MaaT033 to Prevent Complications in Patients with Blood Cancer Undergoing Stem Cell Transplantation
This multi-country trial spanning Germany, France, Belgium, Spain, and the Netherlands tests MaaT033, an oral medication containing healthy gut bacteria, in patients with blood cancers undergoing allogeneic stem cell transplantation. The study aims to prevent complications and improve survival rates.
Inclusion criteria: Patients must be 50 years or older with blood cancer requiring allogeneic stem cell transplantation using a reduced-intensity treatment plan. They must have neutrophils greater than 0.5 G/L, have taken broad-spectrum antibiotics within 90 days before joining, and have a Karnofsky performance score of 70% or higher. A suitable donor must be available.
Exclusion criteria: Those not undergoing allogeneic stem cell transplantation or without blood cancers are excluded.
Study focus: Participants are randomly assigned to receive either MaaT033 or placebo as oral capsules. The study compares overall survival rates at 12 months to determine if restoring healthy gut bacteria helps prevent complications after transplantation.
Investigational drugs: MaaT033 is a fecal microbiotherapy treatment using beneficial bacteria from healthy donors to restore gut bacterial balance. This approach aims to support the immune system and reduce harmful inflammation in transplant recipients.
Study on the Safety and Effectiveness of SMART101 for Patients Undergoing Stem Cell Transplantation for Blood Cancers
This trial in France and Italy evaluates SMART101, a cell therapy using specially prepared T-cell precursors, for patients with blood cancers receiving stem cell transplants from partially matched donors. The study focuses on immune system recovery after transplantation.
Inclusion criteria: Adults aged 18 or older with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes eligible for allogeneic stem cell transplantation with an HLA-mismatched donor can participate. Patients must have a Karnofsky score of 70% or higher, heart ejection fraction of 40% or higher, and adequate lung, liver, and kidney function. Women of childbearing age must use effective birth control for at least one year after treatment.
Exclusion criteria: Those who have not undergone stem cell transplantation, children aged 3-4, and those not meeting the clinical trial criteria are excluded.
Study focus: The trial is conducted in two segments: first determining the optimal SMART101 dose, then assessing safety and immune recovery, particularly CD4+ T-cells. Participants receive SMART101 through intravenous infusion after their transplant along with cyclophosphamide medication. Regular monitoring tracks immune system recovery and overall health outcomes.
Investigational drugs: SMART101 is designed to help immune system recovery by supporting CD4+ T-cell growth after transplantation. Cyclophosphamide is used to prevent graft-versus-host disease by suppressing the immune system during the critical post-transplant period.
Study Comparing Fosfomycin and Ciprofloxacin for Preventing Fever in Patients with Acute Leukemia After Chemotherapy or Stem Cell Transplant
This Spanish trial compares two antibiotics for preventing febrile neutropenia, a serious condition characterized by fever and low white blood cell counts in patients with acute leukemia undergoing intensive chemotherapy or stem cell transplantation.
Inclusion criteria: Adults aged 18 or older with acute leukemia about to receive their first chemotherapy or first stem cell transplant can participate. They must have an expected neutrophil drop lasting at least seven days and, if the expected range is 100-500, at least one infection risk factor such as expected severe mouth sores, age 65 or older, comorbidity index of 3 or more, low blood albumin, or specific chemotherapy doses. Participants must have adequate organ function and life expectancy exceeding 3 months.
Exclusion criteria: Those not at high risk for infection after chemotherapy, without acute leukemia, not undergoing intensive chemotherapy or stem cell transplantation, or outside the specified age range are excluded.
Study focus: Participants are randomly assigned to receive either fosfomycin or ciprofloxacin orally. The study monitors effectiveness in preventing febrile neutropenia and ensures participant safety throughout treatment, with follow-up continuing until neutrophil recovery or 60 days from neutropenia onset.
Investigational drugs: Both fosfomycin and ciprofloxacin are antibiotics that prevent bacterial infections in patients with weakened immune systems. Fosfomycin stops bacterial growth, while ciprofloxacin kills bacteria or prevents their growth, protecting vulnerable patients from potentially life-threatening infections.
Study of Itolizumab with Corticosteroids for Initial Treatment of Acute Graft Versus Host Disease in Patients After Bone Marrow Transplant
This multi-country trial across France, Italy, Spain, Belgium, Germany, and Portugal evaluates itolizumab combined with corticosteroids as initial treatment for acute graft-versus-host disease following bone marrow transplantation.
Inclusion criteria: Participants must be at least 12 years old and weigh more than 40 kg, with locally permitted enrollment for those under 18. They must have received an initial allogeneic stem cell transplant with confirmed engraftment shown by neutrophil counts of at least 500 per cubic millimeter across three separate blood tests. They must have Grade III-IV acute graft-versus-host disease or Grade II with lower digestive tract involvement and have started corticosteroid treatment at appropriate doses within 72 hours before study medication.
Exclusion criteria: The study excludes those who received investigational drugs within 30 days, have allergic reactions to similar medications, active uncontrolled infections, severe liver or kidney problems, uncontrolled heart conditions, active cancer, pregnancy or breastfeeding, or inability to follow study procedures.
Study focus: This double-blind study randomly assigns participants to receive either itolizumab or placebo through intravenous infusion, both combined with corticosteroids. Treatment response is evaluated on Day 29, with continued monitoring through Day 99 to assess the durability of treatment effects.
Investigational drugs: Itolizumab targets specific immune system proteins to reduce inflammation and control immune responses in acute graft-versus-host disease. Corticosteroids are anti-inflammatory medications that suppress the immune system, commonly used to manage inflammatory conditions and combined with itolizumab in this study.
Summary
These six clinical trials represent diverse approaches to improving outcomes for patients undergoing allogenic stem cell transplantation. A notable concentration of trials occurs in France, with four studies, followed by multiple trials in Belgium, Germany, Italy, and Spain. This geographic distribution suggests strong European research infrastructure and expertise in transplantation medicine.
The trials address several critical aspects of transplantation care. Two studies focus specifically on acute graft-versus-host disease treatment, one comparing different corticosteroid approaches with photopheresis and another evaluating itolizumab combined with corticosteroids. Three trials target infection prevention and immune system support, including studies on antibiotic prophylaxis, gut microbiome restoration, and immune cell therapy. One trial examines optimal timing for HPV vaccination after transplantation.
Several medications appear across multiple trials. Corticosteroids, particularly methylprednisolone and prednisone, feature prominently in graft-versus-host disease management. Cyclophosphamide appears in immune system modulation. Novel approaches include MaaT033 for gut microbiome restoration, SMART101 cell therapy for immune recovery, and itolizumab as a targeted immunotherapy.
The trials generally target adult populations, with most requiring participants aged 18 or older, though one study includes patients as young as 12. Several trials specifically focus on older adults, with one requiring participants to be 50 or older. This age distribution reflects both the demographics of transplantation patients and the safety considerations for experimental treatments.
