OHSU

IRB #

IRB00008664

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 (IV-ATG-SCT-01)

Principal Investigator

Richard Maziarz

Study Purpose

This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant.

Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation.

Medical Condition(s)

GVHD
Adult Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Myelodysplastic Syndrome

Eligibility Criteria

18 Years to 65 Years of age

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. Patients with prior malignancy being curatively treated and disease-free for less than 10 years
•Known contraindications to the administration of rabbit immunoglobulin antibodies
•Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products

Age Range

18 - 65

Healthy Volunteers Needed

No

Duration of Participation

The visits will last for at least 12 months after your transplant including a Day 360 study visit. . If the study has not ended, there will be additional follow up visits. You will receive telephone calls after 12 months. These follow up visits and telephone calls could last 3 to 4 years.

Minors Included

No

Contact

Nan Subbiah, 503-494-4603 subbiahn@ohsu.edu

Sponsor

Fresenius Biotech North America

Recruitment End

05/01/2014

Compensation Provided

No


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