Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
NCT ID: NCT01295710
Last Updated: 2019-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2011-10-10
2015-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Interventions
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US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor
* Patients with a Karnofsky Performance Score ≥ 70%
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Neovii Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Kuan
Role: STUDY_DIRECTOR
Neovii Biotech
Locations
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City of Hope
Duarte, California, United States
Stanford University Medical Center, BMT
Stanford, California, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Weill Cornell Medical Center
New York, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Transplant Physician's Group
San Antonio, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
VA Puget Sound Healthcare System
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Countries
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References
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Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.
Other Identifiers
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IV-ATG-SCT-01
Identifier Type: -
Identifier Source: org_study_id
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