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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
GVHD
Adult Acute Myeloid Leukemia
Adult Acute Lymphoid Leukemia
Myelodysplastic Syndrome
Biological: US-ATG-F
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Neovii Biotech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 250
Study Start Date: June 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Placebo
250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation
Biological: Placebo
250 mL normal saline, IV infusion over 6-12 hours 3 days prior to transplantation

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295710

  Show 28 Study Locations
Sponsors and Collaborators
Neovii Biotech
Neovii Biotech NA (formerly Fresenius Biotech North America, Inc.)
Investigators
Study Director: Anne Kuan Neovii Biotech
  More Information

No publications provided

Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT01295710     History of Changes
Other Study ID Numbers: IV-ATG-SCT-01
Study First Received: February 9, 2011
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Neovii Biotech:
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014