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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

Phase 3
18 Years
65 Years
Open (Enrolling)
GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome

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Trial Information

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

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


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

First occurrence of moderate or severe chronic GVHD according to NIH criteria or death from any cause after allogeneic stem cell transplantation

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Julia Jauch, MD

Investigator Role:

Study Director

Investigator Affiliation:

Fresenius Biotech GmbH


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

September 2015

Related Keywords:

  • GVHD
  • Adult Acute Myeloid Leukemia
  • Adult Acute Lymphoid Leukemia
  • Myelodysplastic Syndrome
  • adult acute myeloid leukemia
  • adult acute lymphoid leukemia
  • adult myelodysplastic syndrome
  • allogenic stem cell transplantation
  • unrelated donor
  • GVHD
  • US-ATG-F (Anti-human-T-lymphocyte Immune Globulin, Rabbit)
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



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