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

This study is currently recruiting participants.
Verified April 2013 by Fresenius Biotech GmbH
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by (Responsible Party):
Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:
NCT01295710
First received: February 9, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Fresenius Biotech GmbH:

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

  Show 28 Study Locations
Sponsors and Collaborators
Fresenius Biotech GmbH
Fresenius Biotech North America
Investigators
Study Director: Julia Jauch, MD Fresenius Biotech GmbH
  More Information

No publications provided

Responsible Party: Fresenius Biotech GmbH
ClinicalTrials.gov Identifier: NCT01295710     History of Changes
Other Study ID Numbers: IV-ATG-SCT-01
Study First Received: February 9, 2011
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Fresenius Biotech GmbH:
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:
Graft vs Host Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
Antibodies
Immunoglobulins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013