Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
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
1 other identifier
interventional
260
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
October 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2015
CompletedResults Posted
Study results publicly available
March 20, 2019
CompletedApril 9, 2019
March 1, 2019
4 years
February 9, 2011
January 22, 2019
March 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation
Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause
Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, or death from any cause, assessed up to 48 months
Secondary Outcomes (11)
Overall Survival
Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months
Number of Participants With Chronic GVHD Mild to Severe
Time from first study drug administration until the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Number of Participants With Chronic GVHD Moderate to Severe
Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Number of Participants With Chronic GVHD Severe
Time from first study drug administration until the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Number of Participants With Acute GVHD Grade I-IV
Time from first study drug administration until the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
- +6 more secondary outcomes
Study Arms (2)
US-ATG-F
ACTIVE COMPARATOR20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Placebo
PLACEBO COMPARATOR250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Interventions
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neovii Biotechlead
Study Sites (28)
City of Hope
Duarte, California, 91019, United States
Stanford University Medical Center, BMT
Stanford, California, 94305, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Transplant Physician's Group
San Antonio, Texas, 78229, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Melbourne Hospital
Parkville, Victoria, 03050, Australia
Related Publications (1)
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.
PMID: 37341189DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne Kuan
- Organization
- Neovii
Study Officials
- STUDY DIRECTOR
Anne Kuan
Neovii Biotech
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 14, 2011
Study Start
October 10, 2011
Primary Completion
October 15, 2015
Study Completion
October 15, 2015
Last Updated
April 9, 2019
Results First Posted
March 20, 2019
Record last verified: 2019-03