Thymoglobulin to Prevent Acute Graft vs. Host Disease (GvHD) in Patients With Acute Lymphocytic Leukemia (ALL) or Acute Myelogenous Leukemia (AML) Receiving a Stem Cell Transplant
Condition: Acute Myelogenous Leukemia (AML); Acute Lymphocytic Leukemia (ALL); Graft vs. Host Disease (GvHD)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Graft vs Host Disease
Study type: Interventional

Summary: 
      This study involves the use of a drug called Thymoglobulin, which is approved in the USA to
      treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant
      rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus
      host disease in bone marrow transplantation. This study is to evaluate two (2) doses of
      Thymoglobulin and its safety and effectiveness when used with a "myeloablative" conditioning
      regimen prior to receiving a stem cell transplant (also called bone marrow transplantation)
      from a matched, related donor.

      A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the
      subject's existing bone marrow.

      Subjects meeting all inclusion and exclusion criteria and who have a relative with matching
      (genetically similar) stem cells who are also willing to donate them (i.e.
      matched-related-donor) are eligible to participate in this study. Following myeloablative
      therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood
      stream.

      One of the most common complications of this type of transplant is graft-versus-host disease
      (GvHD). This is a condition where the transplanted donor cells attack the transplant
      recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD
      following stem cell transplantation.

      To enter this study, subjects must be having a matched-related donor stem cell transplant. If
      a subject qualifies for entry into this study, he/she will be assigned to receive
      Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is
      not chosen by the subject or their physician.

      Subjects are admitted to the hospital for the transplant procedure and are treated with
      Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will
      also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly
      used by transplant centers to minimize the risk of GvHD, will not be used in this study.

      Subjects will be monitored during treatment with Thymoglobulin and during the transplant
      hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months
      following the transplant.

      Approximately 60 study subjects from approximately 14 transplant centers in the United States
      and Canada will be enrolled.
    


Intervention name(s): Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]; Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
Intervention type(s): Biological; Biological
Intervention description(s): total dose 4.5 mg/kg; total dose 8.5 mg/kg
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Acute myelogenous leukemia (AML); Acute lymphocytic leukemia (ALL); Anti-T cell antibodies; Allogenic stem cell transplant; Graft vs. Host Disease (GvHD)