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

Neovii Biotech260 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

260

Conditions

GVHD Adult Acute Myeloid Leukemia Adult Acute Lymphoid Leukemia Myelodysplastic Syndrome

Interventions

US-ATG-FBIOLOGICAL

20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

PlaceboBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (28)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Overall Survival

Incidence of death from any cause

Time frame: Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months

Number of Participants With Chronic GVHD Mild to Severe

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

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

Number of Participants With Chronic GVHD Moderate to Severe

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

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

Data from ClinicalTrials.gov

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City of Hope

Duarte, California, United States

Stanford University Medical Center, BMT

Stanford, California, United States

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

...and 18 more locations

Number of Participants With Chronic GVHD Severe

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

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

Number of Participants With Acute GVHD Grade I-IV

Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks

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

Number of Participants With Acute GVHD Grade II-IV

Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks

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

Number of Participants With Acute GVHD Grade III-IV

Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks

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

Number of Participants With Relapse

Participants with relapse or disease recurrence, with death as competing risk

Time frame: Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months

Disease-free Survival

Incidence of relapse or death

Time frame: Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months

Number of Participants With Transplant Related Mortality

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

Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD

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

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