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Antithymocyte Immunoglobulin

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.

Table of contents

Clinical trials overview

The source data includes three interventional studies that mention Antithymocyte Immunoglobulin as part of the treatment plan or comparison group.[1][2][3] These studies are being done in different diseases: acute myeloid leukemia in children receiving transplantation, kidney transplant rejection prevention, and multiple sclerosis.[1][2][3] All three trials are marked Authorised in the source data.[1][2][3]

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.[1] 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.[1]

The source data lists Thymoglobuline among the study drugs in this trial, which is a form of Antithymocyte Immunoglobulin named in the trial record.[1] The primary endpoint is a combined measure called GRFS, which means graft-versus-host disease-free, relapse-free survival.[1] 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.[1]

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.[2] 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.[2]

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.[2] The main endpoint is the mean estimated glomerular filtration rate, or eGFR, at 12 months.[2] eGFR is a kidney function test that estimates how well the transplanted kidney is filtering waste from the blood.[2]

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.[3] The study objective is to compare HSCT with a comparator group that includes alemtuzumab, cladribine, or ocrelizumab in patients with aggressive relapsing remitting MS.[3] HSCT means hematopoietic stem cell transplantation, a treatment approach that uses stem cells as part of therapy.[3]

The source data lists Thymoglobuline among the interventions in this trial record, together with Mavenclad, Sendoxan, Ocrevus, and Lemtrada.[3] The primary endpoint is the proportion of patients with no evidence of disease activity, or NEDA, after 2 years and 5 years.[3] NEDA means there is no protocol-defined disease activity event during the study period.[3]

Main endpoints used in these trials

The trials use endpoints that measure long-term benefit rather than only short-term changes.[1][2][3] In the transplant study for children with AML, the endpoint combines severe graft-versus-host disease, relapse, and death into one survival measure.[1] In the kidney transplant study, the endpoint is kidney function at 12 months using eGFR.[2] In the multiple sclerosis study, the endpoint is the share of patients who remain free of disease activity at 2 and 5 years.[3]

Who the trials are for

These studies focus on three different patient groups.[1][2][3] One group is children with acute myeloid leukemia who are undergoing transplantation.[1] Another group is people receiving a kidney transplant to prevent rejection of the new kidney.[2] The third group is patients with aggressive relapsing remitting multiple sclerosis.[3]

Trial phases and what they mean

The source data includes two Phase 3 trials and one Phase 2 trial.[1][2][3] 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.[2][1][3] The listed enrollment sizes are 135 for the pediatric AML study, 192 for the kidney transplant study, and 100 for the multiple sclerosis study.[1][2][3]

Condition ATG Type Key Findings
Kidney Transplantation Rabbit ATG (Thymoglobuline) Used in combination with other immunosuppressants to prevent acute rejection; may reduce incidence of severe acute GVHD
Stem Cell Transplantation Rabbit ATG Used in non-myeloablative conditioning regimens; may reduce risk of GVHD
Aplastic Anemia Rabbit ATG (Thymoglobuline) Combined with cyclosporine for first-line treatment; shows promise in improving response rates
Graft-versus-host Disease Rabbit ATG Used in prophylaxis regimens; may reduce incidence and severity of acute and chronic GVHD

FAQ

  • What conditions are being studied in trials with Antithymocyte Immunoglobulin? The trials in the source data study acute myeloid leukemia in pediatric transplantation, kidney transplant rejection prevention, and multiple sclerosis. Each trial looks at a different treatment setting and patient group.
  • Who can take part in these trials? The target groups include children undergoing transplant for acute myeloid leukemia, people undergoing kidney transplantation, and patients with aggressive relapsing remitting multiple sclerosis. Exact eligibility depends on the specific study.
  • What phases are the Antithymocyte Immunoglobulin trials in? The source data includes Phase 2 and Phase 3 trials. Phase 2 studies usually focus on safety and early signs of benefit, while Phase 3 studies compare treatment strategies in larger groups.
  • What are the trials trying to measure? The trials measure outcomes such as survival without severe graft-versus-host disease, kidney graft function, and no evidence of disease activity. These are ways to see whether the treatment plan works well over time.
  • Is Antithymocyte Immunoglobulin being studied alone? No. In the trial data, it appears as part of larger treatment plans or comparison groups. The studies are testing whole regimens, not only one medicine by itself.

Ongoing Clinical Trials on Antithymocyte Immunoglobulin

  • Study on Conditioning Treatments with Busulfan, Clofarabine, and Fludarabine for Children with Acute Myeloid Leukemia Undergoing Stem Cell Transplantation

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Finland The Netherlands Norway Sweden

  • Study comparing stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab in patients with aggressive relapsing-remitting multiple sclerosis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark The Netherlands Norway Sweden

  • Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

Glossary

  • Acute myeloid leukemia (AML): A type of blood cancer that affects the bone marrow and blood.
  • Conditioning regimen: A treatment plan given before a transplant to prepare the body and lower the chance of rejection or other problems.
  • Transplantation: A medical procedure where a patient receives cells, tissue, or an organ from a donor or another source.
  • Kidney transplantation: A transplant where a new kidney is placed in a person with kidney failure.
  • Renal allograft rejection: When the body attacks a transplanted kidney. 'Renal' means kidney, and 'allograft' means a transplant from another person.
  • Graft function: How well a transplanted organ is working after surgery.
  • Estimated glomerular filtration rate (eGFR): A blood test estimate of how well the kidneys are filtering waste.
  • Multiple sclerosis: A long-term disease that affects the brain and spinal cord and can cause problems with movement, vision, and balance.
  • Relapsing remitting: A pattern of illness where symptoms get worse in attacks, then improve for a time.
  • No evidence of disease activity (NEDA): A study goal meaning there are no signs of new disease attacks, worsening disability, or new scan activity during the follow-up period.
  • Phase 2: A trial stage that often looks at safety and early signs that a treatment may work.
  • Phase 3: A later trial stage that compares treatments in larger groups to see which strategy works better.

References