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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295710
Recruitment Status : Unknown
Verified May 2016 by Neovii Biotech.
Recruitment status was:  Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):
Neovii Biotech

Brief Summary:
The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

Condition or disease Intervention/treatment Phase
GVHD Adult Acute Myeloid Leukemia Adult Acute Lymphoid Leukemia Myelodysplastic Syndrome Biological: US-ATG-F Biological: Placebo Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2011
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
Biological: US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
Other Name: Anti-human-T-lymphocyte Immune Globulin, Rabbit

Placebo Comparator: Placebo
250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
Biological: Placebo
250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation

Primary Outcome Measures :
  1. First occurrence of moderate or severe chronic GVHD according to NIH criteria or death from any cause after allogeneic stem cell transplantation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Acute GVHD [ Time Frame: 12 months ]
    Incidence of and time to

  2. Chronic GVHD [ Time Frame: 12 months ]
    Incidence of and time to mild to severe, moderate to severe, and severe

  3. Overall survival [ Time Frame: 12 months ]
    Transplant related mortality

  4. Relapse [ Time Frame: 12 months ]
    Incidence of and time of

  5. Systemic immunosuppressive medication for treatment of chronic GVHD [ Time Frame: 12 months ]
    Incidence of and time to start of

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01295710

  Hide Study Locations
United States, California
City of Hope
Duarte, California, United States, 91019
Stanford University Medical Center, BMT
Stanford, California, United States, 94305
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Transplant Physician's Group
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Washington
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 03050
Sponsors and Collaborators
Neovii Biotech
Study Director: Anne Kuan Neovii Biotech

Responsible Party: Neovii Biotech Identifier: NCT01295710     History of Changes
Other Study ID Numbers: IV-ATG-SCT-01
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Neovii Biotech:
adult acute myeloid leukemia
adult acute lymphoid leukemia
adult myelodysplastic syndrome
allogenic stem cell transplantation
unrelated donor
US-ATG-F (Anti-human-T-lymphocyte Immune Globulin, Rabbit)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents