Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Trial ID or NCT#

NCT01295710

Status

not recruiting iconNOT RECRUITING

Purpose

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

Official Title

Phase 3 Study of US-ATG-F 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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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CONTACT

Physician Referrals
(650) 723-0822