Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.

Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.
Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given.

Treatment Arm

Sex: Female, Male

To estimate the proportion of patients with steroid refractory acute Graft vs Host Disease) GvHD who respond (achieve either PR or CR) to Alpha-1 Antitrypsin (AAT) at a dose of 60mg/kg twice weekly for 8 doses
Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.
Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0.

Alpha-1-Antitrypsin (AAT): AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28.

Percentage of Patients That Respond to Treatment

To estimate the proportion of patients in complete remission without additional therapy at four weeks after the last dose of AAT
Complete remission is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0.

Percentage of Patients Who Achieve a Complete Response to Treatment

To estimate the incidence of infection during and following treatment of steroid refractory acute GVHD with AAT

Percentage of Patients With Documented Infection

Survival at 6 months in patients receiving AAT treatment for steroid refractory acute GVHD for patients that achieved a CR or PR.
Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.
Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0.

The Percentage of Patients Alive at 6 Months for Patients in CR or PR

The fold change in levels of plasma biomarkers IL-6, TNF-alpha and ST2 will be measured pre-treatment and after the administration of AAT treatment for steroid refractory GvHD.

Mean Fold Change in Plasma Biomarkers

Plasma levels of Alpha-1-Antitrypsin(AAT)will be measured.

Mean Plasma Levels for Alpha-1-Antitrypsin (AAT)

Overall Study

Dr. Pavan Reddy, MD

Graft vs Host Disease

AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given.

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