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
18 Years
65 Years
Both
GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome
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
transplantation.
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
Type of Study:
Interventional
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:
No
Principal Investigator
Julia Jauch, MD
Investigator Role:
Study Director
Investigator Affiliation:
Fresenius Biotech GmbH
Authority:
United States: Food and Drug Administration
Study ID:
IV-ATG-SCT-01
NCT ID:
NCT01295710
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
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Washington University Medical Center | Saint Louis, Missouri 63105 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| City of Hope | Duarte, California 91010 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Weill Cornell Medical Center | New York, New York 10021 |
| University of Texas Southwestern Medical Center | Dallas, Texas |
| Moffitt Cancer Center | Tampa, Florida 33612 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
| University of North Carolina Hospitals | Chapel Hill, North Carolina 27599 |
| University of Utah School of Medicine | Salt Lake City, Utah 84132 |
| Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
| UPMC Cancer Center | Pittsburgh, Pennsylvania 15232 |
| Stanford University Medical Center, BMT | Stanford, California 94305 |
| Abramson Cancer Center of the University at Perlman Center for Advanced Medicine | Philadelphia, Pennsylvania 19104 |
| Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center | Nashville, Tennessee 37232 |
| Texas Transplant Physician's Group | San Antonio, Texas 78229 |
| VA Puget Sound Healthcare System | Seattle, Washington 98108 |
