๐ฌIn plain words
What the trial is, and whether it could suit you
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Planned anti-leukemic therapy within 21 days of planned dosing
* Use of tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening
* Any prior investigational Listeria product including QUAIL-100
* Live, attenuated vaccine within 4 weeks of first dose