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

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are undergoing allogeneic stem cell transplant from an unrelated donor.

Patients who receive a stem cell transplant may develop something called graft versus host disease (GVHD). GVHD may occur when the T cells from the donor reject your tissue. In order to prevent GVHD, the standard therapy for patients receiving a stem cell transplant is immunosuppressive drugs.

The purpose of this study is determine if an investigational drug called US-ATG-F is effective at preventing GVHD when given along with standard preventive therapy after stem cell transplantation.

All patients in the study will receive the immunosuppressive medication standard of care. Patients will be randomized to one of two study groups:

  • Group 1: US-ATG-F via IV infusion once a day for 3 days plus immunosuppressive medication
  • Group 2: Placebo (does not contain any medication) via IV infusion once a day for 3 days plus immunosuppressive medication

Patients will be in the study for a minimum of 12 months after stem cell transplantation. 

Disease Status and/or Stage

Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Sponsor

Fresenius Biotech GmbH

Key Eligibility

  • Men and women age 18 to 60
  • Undergoing allogeneic stem cell transplantation from unrelated donor
  • Previously diagnosed with Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Usama Gergis, MD

Contact

  • June Greenberg, RN
  • (212) 746-2651
  • [email protected]
  • Bone Marrow Transplant Medical Practice
  • (212) 746-2119

Protocol ID

IV-ATG-SCT-01

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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