Horse Anti-Thymocyte Globulin (hATG)

Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)

What's the purpose of the trial?

This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
140
Last Updated
1 month ago
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Participating Centers

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Experimental Treatments

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  • Antithymocyte Globulin (ATG) is an antibody preparation made from rabbits or horses immune cells altered with human thymocytes. ATG is used to prevent or treat acute cellular rejection after solid organ transplantation and as a therapy for certain other blood disorders.
  • Cyclosporine is a drug that suppresses the immune system. It may be used in patients who have had organ transplants, autoimmune disorders, or graft vs host disease.
  • Filgrastim is a bone marrow stimulant medication used to treat low white blood cell counts that are common side effects of cancer treatments. 
  • Methylprednisolone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Pegfilgrastim is a medication given by subcutaneous injection to treat low white blood cells (neutropenia) caused by some cancer medicines.

Arms / Cohorts

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Accepting patients

Methylprednisolone + hATG + Cyclosporine + G-CSF

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