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

Primary Purpose

GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
US-ATG-F
Placebo
Sponsored by
Neovii Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for GVHD focused on measuring 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)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope
  • Stanford University Medical Center, BMT
  • University of Florida Shands Cancer Center
  • Moffitt Cancer Center
  • University of Chicago Medical Center
  • Loyola University Medical Center
  • University of Kansas Medical Center
  • Tulane University Health Sciences Center
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Mayo Clinic
  • Washington University Medical Center
  • Weill Cornell Medical Center
  • University of North Carolina Hospitals
  • Duke University Medical Center
  • University of Oklahoma Health Sciences Center
  • Oregon Health and Science University
  • Penn State Hershey Cancer Institute
  • Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
  • Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
  • University of Texas Southwestern Medical Center
  • Texas Transplant Physician's Group
  • University of Utah School of Medicine
  • VA Puget Sound Healthcare System
  • Fred Hutchinson Cancer Research Center
  • Royal Adelaide Hospital
  • Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

US-ATG-F

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Incidence of death from any cause
Number of Participants With Chronic GVHD Mild to Severe
Participants with 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
Number of Participants With Chronic GVHD Moderate to Severe
Participants with 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
Number of Participants With Chronic GVHD Severe
Participants with 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
Number of Participants With Acute GVHD Grade I-IV
Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks
Number of Participants With Acute GVHD Grade II-IV
Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks
Number of Participants With Acute GVHD Grade III-IV
Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks
Number of Participants With Relapse
Participants with relapse or disease recurrence, with death as competing risk
Disease-free Survival
Incidence of relapse or death
Number of Participants With Transplant Related Mortality
Participants with transplant related mortality
Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD
Participants who started on systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks

Full Information

First Posted
February 9, 2011
Last Updated
March 29, 2019
Sponsor
Neovii Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT01295710
Brief Title
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2011 (Actual)
Primary Completion Date
October 15, 2015 (Actual)
Study Completion Date
October 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovii Biotech

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GVHD, Adult Acute Myeloid Leukemia, Adult Acute Lymphoid Leukemia, Myelodysplastic Syndrome
Keywords
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)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-ATG-F
Arm Type
Active Comparator
Arm Description
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Intervention Type
Biological
Intervention Name(s)
US-ATG-F
Other Intervention Name(s)
Anti-human-T-lymphocyte Immune Globulin, Rabbit
Intervention Description
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Primary Outcome Measure Information:
Title
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
Description
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 Frame
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 Outcome Measure Information:
Title
Overall Survival
Description
Incidence of death from any cause
Time Frame
Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months
Title
Number of Participants With Chronic GVHD Mild to Severe
Description
Participants with 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
Time Frame
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
Title
Number of Participants With Chronic GVHD Moderate to Severe
Description
Participants with 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
Time Frame
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
Title
Number of Participants With Chronic GVHD Severe
Description
Participants with 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
Time Frame
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
Title
Number of Participants With Acute GVHD Grade I-IV
Description
Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks
Time Frame
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
Title
Number of Participants With Acute GVHD Grade II-IV
Description
Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks
Time Frame
Time from first study drug administration until the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Title
Number of Participants With Acute GVHD Grade III-IV
Description
Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks
Time Frame
Time from first study drug administration until the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Title
Number of Participants With Relapse
Description
Participants with relapse or disease recurrence, with death as competing risk
Time Frame
Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months
Title
Disease-free Survival
Description
Incidence of relapse or death
Time Frame
Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months
Title
Number of Participants With Transplant Related Mortality
Description
Participants with transplant related mortality
Time Frame
Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months
Title
Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD
Description
Participants who started on systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks
Time Frame
Time from first study drug administration until start of systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks, assessed up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Kuan
Organizational Affiliation
Neovii Biotech
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91019
Country
United States
Facility Name
Stanford University Medical Center, BMT
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Transplant Physician's Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
VA Puget Sound Healthcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
03050
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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