Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Weight >/= 10 kg
Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment
Lanksy/Karnofsky score > 60
Participants of childbearing potential must agree to use contraception to prevent pregnancy
Active Grade II acute graft versus host disease (aGVHD) requiring > 0.5 mg/kg methylprednisolone or any diagnosis of Grade III/IV aGVHD
Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation
Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin
Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention
Sequential
QUAIL-100
Biological/Vaccinelive, attenuated bacterial therapeutic
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
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