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

This study is currently recruiting participants.
Verified November 2013 by Neovii Biotech
Sponsor:
Collaborator:
Neovii Biotech NA (formerly Fresenius Biotech North America, Inc.)
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT01295710
First received: February 9, 2011
Last updated: November 26, 2013
Last verified: November 2013

February 9, 2011
November 26, 2013
June 2011
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01295710 on ClinicalTrials.gov Archive Site
  • Acute GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of and time to
  • Chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of and time to mild to severe, moderate to severe, and severe
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Transplant related mortality
  • Relapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of and time of
  • Systemic immunosuppressive medication for treatment of chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of and time to start of
  • Incidence of and time to acute GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of and time to mild to severe, moderate to severe, and severe chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of and time of relapse [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of and time to start of systemic immunosuppressive medication for treatment of chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • GVHD
  • Adult Acute Myeloid Leukemia
  • Adult Acute Lymphoid Leukemia
  • Myelodysplastic Syndrome
  • 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
  • Biological: Placebo
    250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
  • 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
    Intervention: Biological: US-ATG-F
  • Placebo Comparator: Placebo
    250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Not Provided
United States,   Australia
 
NCT01295710
IV-ATG-SCT-01
Yes
Neovii Biotech
Neovii Biotech
Neovii Biotech NA (formerly Fresenius Biotech North America, Inc.)
Study Director: Anne Kuan Neovii Biotech
Neovii Biotech
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP