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

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

US-ATG-F

Placebo

Anne Kuan

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

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

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

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

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

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

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

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

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

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

Participants with transplant related mortality

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

Neovii Biotech

Total

18 years to ≤40 years

>40 years to 65 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Australia

Region of Enrollment

Disease

Source of stem cells

Conditioning regimen

Participant's absolute lymphocyte count (ALC) prior to the start of study drug administration on Day -3, i.e. 3 days prior to stem cell transplantation

ALC at Study Day -3 Overall Study

Regimen: CY-TBI

Regimen: BU-CY

Regimen: FLU-BU

Regimens: BU-CY + FLU-BU

Participant's absolute lymphocyte count (ALC) prior to the start of study drug administration on Day -3, i.e. 3 days prior to stem cell transplantation. Participants are grouped based on administered conditioning regimen.

Analysis of patients who received a specific conditioning regimen

ALC at Study Day -3 by Conditioning Regimen

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

Overall Survival

Number of Participants With Chronic GVHD Mild to Severe

Number of Participants With Chronic GVHD Moderate to Severe

Number of Participants With Chronic GVHD Severe

Number of Participants With Acute GVHD Grade I-IV

Number of Participants With Acute GVHD Grade II-IV

Number of Participants With Acute GVHD Grade III-IV

Number of Participants With Relapse

Disease-free Survival

Number of Participants With Transplant Related Mortality

Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD

Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators 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

Number of Participants With First Occurrence of Moderate or Severe Chronic GVHD According to 2005 NIH Criteria as Determined by Principal Investigator or Death From Any Cause After Allogeneic Stem Cell Transplantation

Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause

Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS)

Participants with grade III-IV acute GVHD as determined by the Investigator, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause

Grade III-IV Acute GVHD-free, GRFS

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. Analysis was conducted by conditioning regimen.

Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen

Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause. Analysis was conducted by conditioning regimen.

Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen

Participants with grade III-IV acute GVHD as determined by the Investigator, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause. Analysis was conducted by conditioning regimen.

Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen

Incidence of death from any cause. Analysis was conducted by conditioning regimen.

Overall Survival by Conditioning Regimen

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. Analysis was conducted by conditioning regimen.

Chronic GVHD Mild to Severe by Conditioning Regimen

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. Analysis was conducted by conditioning regimen.

Chronic GVHD Moderate to Severe by Conditioning Regimen

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. Analysis was conducted by conditioning regimen.

Chronic GVHD Severe by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Acute GVHD Grade I-IV by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Acute GVHD Grade II-IV by Conditioning Regimen

Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.

Acute GVHD Grade III-IV by Conditioning Regimen

Participants with relapse or disease recurrence, with death as competing risk. Analysis was conducted by conditioning regimen.

Relapse by Conditioning Regimen

Incidence of relapse or death. Analysis was conducted by conditioning regimen.

Disease-free Survival by Conditioning Regimen

Participants with transplant related mortality. Analysis was conducted by conditioning regimen.

Spots Global Cancer Trial Database for adult acute lymphoid leukemia