--- a +++ b/clusters/9knumclustersv2/clust_1352.txt @@ -0,0 +1,44 @@ +Patients must not be known to be refractory to red blood cell or platelet transfusions +Hemoglobin ? g/dL with no blood transfusions (packed red blood cells and platelet transfusions) in the past days, within days prior to administration of study treatment +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable +Whole blood transfusions in the last days prior to entry to the study which may interfere with gBRCA testing (packed red blood cells and platelet transfusions are acceptable) +No platelet transfusions within days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time +Transfusions are permitted to meet both the platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions +Measured within days prior to registration: hemoglobin >= . g/dL with no blood transfusions (packed red blood cells in the past days is permitted) +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) +Liver MRI (? days prior to initiation of transplant conditioning) to document hepatic iron content is required for participants who are currently receiving ? packed red blood cell transfusions for ? year or have received ? packed red blood cell transfusions (cumulative). Participants who have hepatic iron content ? mg Fe/ g liver dry weight by liver MRI must have a liver biopsy and histological examination/documentation of the absence of cirrhosis, bridging fibrosis and active hepatitis (? days prior to initiation of transplant conditioning). +Blood (packed red blood cells, platelets) transfusions within month prior to study start +Unable to accept blood product transfusions +Use of red blood cell or platelet transfusions within weeks of treatment +Within days prior to registration: Hemoglobin >= g/dL; patients may be transfused packed red blood cells (PRBCs) up to week prior to when enrollment labs are drawn; on study, transfusions may be given as clinically indicated +Patients who have had a whole blood transfusion within days prior to enrollment. (Packed red blood cells and platelet transfusions are acceptable) +Packed red blood cell transfusions or erythropoietin therapy within days prior to the study enrollment unless erythropoietin therapy has been used to maintain a stable condition for at least month prior to the enrollment +Whole blood transfusions in the last days prior to entry to the study +Hematologic function, as follows (no red blood cell or platelet transfusions are allowed within days of the first dose of enfortumab vedotin): +Within two weeks prior to enrollment: Not refractory to red cell or platelet transfusions +Patients should not be known to be refractory to red blood cell or platelet transfusions +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) +Patients known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support. +Patients must be willing to accept blood product transfusions +Whole blood transfusions in the last days +Transfusion independent (no red blood cell or platelet transfusions in the preceding weeks of screening) +PHASE I: No blood transfusions days prior to study entry +PHASE II: No blood transfusions days prior to study entry +Patients refractory to red blood cell or platelet transfusions +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable). +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) +Anemia that requires red blood cell transfusions +Patients in CRi must have evidence of hematologic recovery after prior therapy independent of red blood cell transfusions +blood transfusions prior to , +Whole blood transfusions in the last days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable. +Within days after subjects signed the treatment consent: Hemoglobin >= g/dl; patients may be transfused packed red blood cells (PRBCs) up to week prior to when enrollment labs are drawn; on study, transfusions may be given as clinically indicated +Unwilling to accept blood product transfusions +Patients refractory to red blood cell or platelet transfusions +Subject has received blood transfusions or hematopoietic factor therapy within days prior to the first dose of study drug. +Blood transfusions or hemopoietic factor therapy +Patients with leukemia must not be known to be refractory to red blood cell or platelet transfusions. +Any patient requiring chronic maintenance of red blood cell, white blood cell or granulocyte counts through the use of blood transfusions or growth factor support (e.g. Neulasta, Neupogen) +Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > units packed red blood cells every months) +Blood transfusions or hemopoietic factor therapy +Platelet count >= X ^/L w/o blood transfusions for days preceding lab assessment, obtained within days prior to PET scan