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Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Not Recruiting
Trial ID: NCT01295710
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
Stanford Investigator(s)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
biological: Placebo
biological: US-ATG-F
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822