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Clinical Trial VICCBMT1218

Title

A Randomized, Prospective, Double Blind, Placebo-Controlled, Phase 3 Study of US-ATG-F Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients after Allogeneic Stem Cell Transplantation from Unrelated Donors

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCBMT1218
  • Open Date: 09/04/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective is to demonstrate the efficacy of US-ATG-F versus Placebo when combined with standard GVHD prophylaxis (TAC plus MTX) in moderate to severe chronic GVHD-free survival after allogeneic stem cell transplantation from unrelated donors.
  • Disease Sites: Leukemia; Myelodysplastic Syndrome
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: US-ATG-F
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01295710
  • Secondary Protocol No: IV-ATG-SCT-01

Description

Patients are invited to take part in this study if they have acute lymphoid leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS) and are going to have a stem cell transplant. Patients who receive a stem cell transplant (SCT) may develop graft versus host disease (GVHD). GVHD may occur when the T cells from the donor rejects the patients tissue. In order to try to prevent GVHD, the standard therapy for patients receiving a stem cell transplant is immunosuppressive drugs. Immunosuppressive drugs are thought to weaken the ability of the donor's T cells to attack the organs and tissues of patients. The purpose of this study is to find out if the investigational drug called US-ATG-F can be safely used to prevent graft versus host disease (GVHD), with a focus on moderate to severe chronic GVHD. Study participants will receive the immunosuppressive drugs Tacrolimus and Methotrexate. Tacrolimus and Methotrexate are standard immunosuppressive GVHD prevention medicines. The investigational drug that is being studied in this trial, US-ATG-F, may be given to patients in addition to Tacrolimus and Methotrexate. Study participants will have an equal (50%) chance of receiving either US ATG F, or placebo (0.9% sodium chloride IV solution but does not contain any medicine). Before their stem cell transplant, participants will be randomly assigned (like a flip of a coin) to receive placebo or US-ATG-F from an IV infusion. This study is double blinded, which means that both patients and the study doctor will not know if they are receiving the study drug or the placebo. The study pharmacist will be the only person at the study center who has access to this information.

Eligibility

Ages Eligible for Study:18 Years to 65 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Key Inclusion Criteria:
• Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of one of the primary diseases in early or intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia, and myelodysplastic syndrome)
• Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor
• Patients with a Karnofsky Performance Score ≥ 70%
Key Exclusion Criteria:
• Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS)
• Bacterial, viral, or fungal infections
• Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have been tested positive for HIV
• Patients with any concurrent malignancy. Cancer treated with curative intent < 5 years previously will not be allowed except for patients with resected basal cell carcinoma or treated cervical carcinoma in situ
• Known contraindications to the administration of rabbit immunoglobulin antibodies
• Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products