Memorial Sloan Kettering Cancer Center
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation).
Inclusion Criteria: * Age ≥ 18 * Ability to swallow capsules * Have undergone allo-HCT from any donor source * Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed * Steroid-refractory, steroid-dependent or intolerant, defined as: * Progressive (i.e., increase in stage of the lower GI tract) after 3 days of treatment with corticosteroids (≥1 mg/kg/day prednisone or IV equivalent), or * Failure to improve (i.e., decrease in stage in the GI tract) after 5 days of corticosteroid treatment (≥1 mg/kg/day prednisone or IV equival…
Ruxolitinib will be initiated concurrently with LBP treatment at a starting dose of 10 mg twice daily and will continue for at least 28 days.
The LBP-MARCO consists of five capsules of individual bacterial strains that will be given at least 1 day apart from one another and within 7-10 days of the first dose.