In short
Clinical trials involving Antithymocyte Immunoglobulin are studying how it is used in different treatment settings, mainly transplant care and severe autoimmune disease. These studies look at outcomes such as survival, graft function, and disease activity in children and adults. The trials also help define which patients may benefit most and how well the study regimens perform.
Key points
- Clinical trials involving Antithymocyte Immunoglobulin in the source data are studying transplant-related care and multiple sclerosis. One Phase 3 study is in children with acute myeloid leukemia, looking at a transplant conditioning regimen and long-term survival without severe graft-versus-host disease, relapse, or death. Another trial is a Phase 2 kidney transplant study focused on graft function at 12 months, measured by eGFR. A third Phase 3 study in aggressive relapsing remitting multiple sclerosis is comparing treatment strategies and measuring no evidence of disease activity over 2 and 5 years. Together, these trials show that Antithymocyte Immunoglobulin is being studied as part of broader treatment plans in different patient groups.
Clinical trials overview
The source data includes three interventional studies that mention Antithymocyte Immunoglobulin as part of the treatment plan or comparison group. These studies are being done in different diseases: acute myeloid leukemia in children receiving transplantation, kidney transplant rejection prevention, and multiple sclerosis. All three trials are marked Authorised in the source data.
Pediatric transplant study in acute myeloid leukemia
One Phase 3 study is titled “Studying Conditioning Regimen In Pediatric Transplantation -AML” and includes children with acute myeloid leukemia. The study is testing whether one conditioning regimen with an alkylator plus two antimetabolites gives better 2-year survival without severe graft-versus-host disease, without chronic non-limited graft-versus-host disease, and without relapse than a regimen with three alkylating agents.
The source data lists Thymoglobuline among the study drugs in this trial, which is a form of Antithymocyte Immunoglobulin named in the trial record. The primary endpoint is a combined measure called GRFS, which means graft-versus-host disease-free, relapse-free survival. This endpoint counts whether a patient stays free from severe graft-versus-host disease, chronic non-limited graft-versus-host disease, relapse, or death during follow-up.
Kidney transplant study and graft function
Another study is the BESTOW trial, a Phase 2, multicenter, randomized, open-label study in people undergoing kidney transplantation. The trial is looking at safety and efficacy of tegoprubart and comparing graft function at 12 months after transplant in participants treated with tegoprubart versus tacrolimus-treated participants.
The source data lists Thymoglobuline as one of the study drugs in this trial record, along with other transplant medicines such as Prograf, CellCept, Myfortic, and Prednisolone. The main endpoint is the mean estimated glomerular filtration rate, or eGFR, at 12 months. eGFR is a kidney function test that estimates how well the transplanted kidney is filtering waste from the blood.
Multiple sclerosis study in aggressive relapsing remitting disease
The third study, called RAM-MS, is a Phase 3 prospective randomized trial in people with multiple sclerosis. The study objective is to compare HSCT with a comparator group that includes alemtuzumab, cladribine, or ocrelizumab in patients with aggressive relapsing remitting MS. HSCT means hematopoietic stem cell transplantation, a treatment approach that uses stem cells as part of therapy.
The source data lists Thymoglobuline among the interventions in this trial record, together with Mavenclad, Sendoxan, Ocrevus, and Lemtrada. The primary endpoint is the proportion of patients with no evidence of disease activity, or NEDA, after 2 years and 5 years. NEDA means there is no protocol-defined disease activity event during the study period.
Main endpoints used in these trials
The trials use endpoints that measure long-term benefit rather than only short-term changes. In the transplant study for children with AML, the endpoint combines severe graft-versus-host disease, relapse, and death into one survival measure. In the kidney transplant study, the endpoint is kidney function at 12 months using eGFR. In the multiple sclerosis study, the endpoint is the share of patients who remain free of disease activity at 2 and 5 years.
Who the trials are for
These studies focus on three different patient groups. One group is children with acute myeloid leukemia who are undergoing transplantation. Another group is people receiving a kidney transplant to prevent rejection of the new kidney. The third group is patients with aggressive relapsing remitting multiple sclerosis.
Trial phases and what they mean
The source data includes two Phase 3 trials and one Phase 2 trial. Phase 2 trials usually look more closely at safety and early signs of benefit, while Phase 3 trials compare treatment strategies in larger groups of patients. The listed enrollment sizes are 135 for the pediatric AML study, 192 for the kidney transplant study, and 100 for the multiple sclerosis study.