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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295710
First Posted: February 14, 2011
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neovii Biotech
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Acute GVHD [ Time Frame: 12 months ]
    Incidence of and time to

  • Chronic GVHD [ Time Frame: 12 months ]
    Incidence of and time to mild to severe, moderate to severe, and severe

  • Overall survival [ Time Frame: 12 months ]
    Transplant related mortality

  • Relapse [ Time Frame: 12 months ]
    Incidence of and time of

  • Systemic immunosuppressive medication for treatment of chronic GVHD [ Time Frame: 12 months ]
    Incidence of and time to start of


Enrollment: 260
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295710


  Show 28 Study Locations
Sponsors and Collaborators
Neovii Biotech
Investigators
Study Director: Anne Kuan Neovii Biotech
  More Information

Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT01295710     History of Changes
Other Study ID Numbers: IV-ATG-SCT-01
First Submitted: February 9, 2011
First Posted: February 14, 2011
Last Update Posted: May 16, 2016
Last Verified: May 2016

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:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents