Clinical trial NCT01295710: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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)
Lead sponsor: Neovii Biotech
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Overall Survival
timeFrame: Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months
measure: Number of Participants With Chronic GVHD Mild to Severe
timeFrame: 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
measure: Number of Participants With Chronic GVHD Moderate to Severe
timeFrame: 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
measure: Number of Participants With Chronic GVHD Severe
timeFrame: 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
measure: Number of Participants With Acute GVHD Grade I-IV
timeFrame: 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
measure: Number of Participants With Acute GVHD Grade II-IV
timeFrame: 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
measure: Number of Participants With Acute GVHD Grade III-IV
timeFrame: 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
measure: Number of Participants With Relapse
timeFrame: Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months
measure: Disease-free Survival
timeFrame: Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months
measure: Number of Participants With Transplant Related Mortality
timeFrame: Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months
measure: Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD
timeFrame: 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
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center, BMT
state: California
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University at Perlman Center for Advanced Medicine
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Physician's Group
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Neovii Biotech
name: Anne Kuan
role: STUDY_DIRECTOR
References: