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Completed

NCT Number: NCT01295710

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

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.

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Key information

Conditions

GVHD Adult Acute Lymphoid Leukemia Adult Acute Myeloid Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

US-ATG-F

Biological

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 names: Anti-human-T-lymphocyte Immune Globulin, Rabbit

Placebo

Biological

250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Neovii Biotech

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 14, 2011
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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