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

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.
 
ClinicalTrials.gov Identifier: NCT01295710
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : March 20, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
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
Actual Study Start Date : October 10, 2011
Actual Primary Completion Date : October 15, 2015
Actual Study Completion Date : October 15, 2015


Arm Intervention/treatment
Active Comparator: US-ATG-F
20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 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 6-16 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 6-16 hours 3 days prior to transplantation
Biological: Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation




Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
    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, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months ]
    Incidence of death from any cause

  2. Number of Participants With Chronic GVHD Mild to Severe [ Time Frame: 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 ]
    Participants with 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

  3. Number of Participants With Chronic GVHD Moderate to Severe [ Time Frame: 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 ]
    Participants with 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

  4. Number of Participants With Chronic GVHD Severe [ Time Frame: 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 ]
    Participants with 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

  5. Number of Participants With Acute GVHD Grade I-IV [ Time Frame: 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 ]
    Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks

  6. Number of Participants With Acute GVHD Grade II-IV [ Time Frame: 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 ]
    Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks

  7. Number of Participants With Acute GVHD Grade III-IV [ Time Frame: 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 ]
    Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks

  8. Number of Participants With Relapse [ Time Frame: Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months ]
    Participants with relapse or disease recurrence, with death as competing risk

  9. Disease-free Survival [ Time Frame: Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months ]
    Incidence of relapse or death

  10. Number of Participants With Transplant Related Mortality [ Time Frame: Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months ]
    Participants with transplant related mortality

  11. Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD [ Time Frame: 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 ]
    Participants who started on systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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


Locations
Show Show 28 study locations
Sponsors and Collaborators
Neovii Biotech
Investigators
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Study Director: Anne Kuan Neovii Biotech
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Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT01295710    
Other Study ID Numbers: IV-ATG-SCT-01
First Posted: February 14, 2011    Key Record Dates
Results First Posted: March 20, 2019
Last Update Posted: April 9, 2019
Last Verified: March 2019
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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immune System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immunoglobulins
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents