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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)
Both
GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome

Thank you

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 ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Washington University Medical CenterSaint Louis, Missouri  63105
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Massachusetts General HospitalBoston, Massachusetts  02114-2617
City of HopeDuarte, California  91010
Duke University Medical CenterDurham, North Carolina  27710
University of Chicago Medical CenterChicago, Illinois  60637
Weill Cornell Medical CenterNew York, New York  10021
University of Texas Southwestern Medical CenterDallas, Texas  
Moffitt Cancer CenterTampa, Florida  33612
Oregon Health and Science UniversityPortland, Oregon  97201
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
University of North Carolina HospitalsChapel Hill, North Carolina  27599
University of Utah School of MedicineSalt Lake City, Utah  84132
Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033
UPMC Cancer CenterPittsburgh, Pennsylvania  15232
Stanford University Medical Center, BMTStanford, California  94305
Abramson Cancer Center of the University at Perlman Center for Advanced MedicinePhiladelphia, Pennsylvania  19104
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer CenterNashville, Tennessee  37232
Texas Transplant Physician's GroupSan Antonio, Texas  78229
VA Puget Sound Healthcare SystemSeattle, Washington  98108