--- a +++ b/clusters/9knumclustersv2/clust_1570.txt @@ -0,0 +1,86 @@ +Within weeks prior to screening step registration and within weeks prior to treatment step registration: Total bilirubin =< . X institutional upper limit of normal (ULN) (unless documented Gilberts syndrome, for which bilirubin =< x institutional ULN is permitted) +Total bilirubin =< . x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilberts syndrome +Total bilirubin within normal institutional limits (unless patient has Gilberts syndrome in which total bilirubin should be =< x upper limit of normal [ULN]) +Total bilirubin < . X upper limit of normal unless known diagnosis of Gilberts disease +Total bilirubin =< . x institutional upper limit of normal, unless due to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN) (unless hepatic dysfunction is caused by cGVHD) +Total serum bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts syndrome or hemolysis, in which case =< . x ULN is allowed +Total bilirubin =< . x upper limit of normal (ULN) (unless Gilberts disease), =< days prior to CD +Total serum bilirubin < x upper limit of normal (ULN), unless due to Gilberts syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI) +Bilirubin ? . x ULN, unless due to Gilberts syndrome (unless considered due to leukemic organ involvement) +Direct bilirubin ? X institutional upper limit of normal (ULN) (unless due to known Gilberts syndrome or compensated hemolysis directly attributable to CLL) +Adequate hepatic function including total bilirubin < x upper limit of normal (ULN) unless increase is due to Gilberts disease or leukemic involvement +Total bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts disease obtained =< days prior to registration +Total bilirubin > x institutional upper limit of normal (ULN) (unless documented Gilberts syndrome) +Total serum bilirubin =< x upper limit of normal (ULN), unless due to Gilberts syndrome. +Total bilirubin < .x upper limit of normal (ULN) unless increase is due to Gilberts disease or leukemic involvement +Bilirubin < . x upper limit of normal (ULN) unless believed due to leukemic infiltration +Total serum bilirubin =< x upper limit of normal (ULN), unless due to Gilberts syndrome. +Total bilirubin =< . x upper limit of normal (ULN) unless elevation due to Gilberts syndrome obtained =< days prior to registration +Total bilirubin =< . x upper limit of normal (ULN) (unless related to Gilberts or Meulengrachts syndrome) +Total bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts disease obtained =< days prior to registration +Serum bilirubin =< . x institutional upper limit of normal (ULN) unless diagnosed with Gilberts syndrome. +Total bilirubin =< . x institutional upper limit of normal (ULN) (unless due to Gilberts disease or disease-related hemolysis, then =< . x ULN) +Total bilirubin =< . ULN (upper limit of normal), unless due to Gilberts syndrome +LYMPHODEPLETION: Bilirubin =< . x upper limit of normal (ULN) unless attributed to Gilberts syndrome, obtained within hrs prior to procurement +Obtained =< days prior to registration: Total bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts syndrome +Direct bilirubin =< X institutional upper limit of normal (ULN) (unless due to known Gilberts syndrome or compensated hemolysis directly attributable to CLL) +Bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts syndrome +Total bilirubin =< . times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (e.g., Gilberts disease) +Total bilirubin =< . times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilberts disease) +Bilirubin =< x the upper limit of normal (except Gilberts syndrome) +PHASE I: Total bilirubin =< . x upper limit of normal (ULN) (unless Gilberts disease) +Total bilirubin > . x upper limit of normal (ULN) (unless evidence of Gilberts disease) +Total serum bilirubin =< . x upper limit of normal (ULN) unless attributable to Gilberts syndrome +Total bilirubin =< x institutional upper limit of normal, unless there is a known history of Gilberts disease +Total bilirubin =< . x the upper limit of the normal range (ULN) unless related to disease or patient known to have underlying Gilberts disease +Total bilirubin =< x upper limit of normal (ULN) (unless related to lymphoma or Gilberts disease) OR =< x ULN for subjects with documented or suspected Gilberts disease, or related to involvement of the liver by the lymphoma, obtained =< days prior to registration +Total bilirubin =< . x the upper limit of normal (ULN) unless considered due to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts syndrome (< if liver involvement with primary tumor) +Bilirubin =< x upper limit of normal (ULN) (unless documented Gilberts syndrome, for which bilirubin =< x upper limit of normal [ULN] is permitted) obtained within weeks prior to registration +RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< x upper limit of normal (ULN) (unless documented Gilberts syndrome, for which Bilirubin =< x upper limit of normal [ULN] is permitted); obtained within weeks prior to registration +Total serum bilirubin < x upper limit normal (unless due to hemolysis, Gilberts syndrome, or ineffective erythropoiesis) +Total bilirubin =< . x upper limit of normal (ULN) (unless considered due to Gilberts syndrome or hemolysis) +Within days prior to day of protocol therapy unless otherwise stated: Total bilirubin =< . X upper limit of normal (ULN) OR if Gilberts syndrome =< . X ULN +Serum bilirubin =< . x institutional upper limit of normal (ULN) unless diagnosed with Gilberts syndrome. +Total bilirubin =< . institutional upper limit of normal (ULN), unless known Gilberts syndrome has been diagnosed +Total bilirubin =< . x upper limit of normal unless clearly related to Gilberts disease, hemolysis or leukemic infiltrate +Serum bilirubin greater than times the upper limit of normal, unless attributed to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN) (unless Gilberts syndrome or disease infiltration of the liver is present) +Total bilirubin < . times the upper limit of normal (ULN) unless due to Gilberts disease or hemolysis +Total bilirubin =< . x institutional upper limit of normal; unless due to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN) (unless Gilberts syndrome or disease infiltration of the liver is present) +Total bilirubin =< .X upper limit of normal (ULN) unless secondary to Gilberts disease +Total serum bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts disease +Total bilirubin < X institutional upper limit of normal (ULN) unless predominantly indirect and therefore likely due to hemolysis or Gilberts syndrome +Total bilirubin =< . X upper limit of normal (ULN) unless history of Gilberts syndrome documented prior to first-line treatment of cancer and other liver function tests are within normal limits +Total bilirubin =< . X upper limit of normal (ULN) (unless bilirubin rise due to Gilberts syndrome) +Total bilirubin =< . times the upper limit of normal (ULN) unless due to Gilberts disease or hemolysis +Total bilirubin =< . x upper limit of normal (ULN), unless due to Gilberts syndrome +Total bilirubin < . times institutional upper normal limit (unless due to disease involvement of liver, hemolysis or a known history of Gilberts disease) +Total bilirubin =< X institutional upper limit of normal unless nd to Gilberts disease +Total bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts disease +PART B: Total bilirubin =< . x institutional upper limit of normal (ULN), unless due to Gilberts syndrome +Total bilirubin =< . x upper limit of normal (ULN) unless Gilberts syndrome or disease infiltration of the liver is present +Total bilirubin =< . x institutional upper limit of normal (unless elevated from documented Gilberts syndrome) +Bilirubin =< x the upper limit of normal (except Gilberts syndrome) +Serum total bilirubin =< . x upper limit of normal (ULN) (unless known Gilberts disease) +Total bilirubin =< . upper limit of normal (ULN) for the laboratory unless resulting from hemolysis +Total serum bilirubin < x upper limit of normal (unless due to hemolysis or Gilberts syndrome, then no upper limit) +POST-TRANSPLANT ELIGIBILITY CRITERIA:\r\n* In complete remission (CR) (including incomplete blood count recovery [CRi] and marrow CR) on bone marrow biopsy for response assessment after HCT (typically day +)\r\n* Patient is within - days after HCT\r\n* Absolute neutrophil count (ANC) >= /uL, platelet count >= ,/uL\r\n* ECOG performance status -\r\n* Adequate major organ function, as defined by AST and ALT =< x upper limit of normal\r\n* Total serum bilirubin < x upper limit of normal (unless due to hemolysis or Gilberts syndrome, then no upper limit)\r\n* Creatinine =< x upper limit of normal unless there is known chronic kidney disease (CKD) (creatinine must be at baseline for subjects with CKD)\r\n* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of days after study treatment, for all male and female patients who are fertile +Total bilirubin =< . upper limit of normal (ULN) (unless Gilberts syndrome or disease infiltration of the liver is present) +Liver function tests less than x upper limit of normal range (unless related to medications or Gilberts disease) +Total bilirubin =< . x the upper limit of normal (ULN), unless presence of Gilberts syndrome +Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilberts disease +Total bilirubin > x institutional upper limit of normal (ULN) (unless documented Gilberts syndrome) +Total bilirubin =< . X institutional upper limit of normal (unless associated with Gilberts syndrome) +Total bilirubin < . x upper limit of reference range (ULRR), unless the patient meets the criteria for Gilberts syndrome +Total bilirubin =< . x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilberts syndrome +Total bilirubin < . X institutional upper limit of normal (unless associated with Gilberts syndrome) +Total bilirubin =< . x upper limit of normal (ULN) unless due to Gilberts disease +Total bilirubin >= . x upper limit of normal (ULN) (unless documented Gilberts) +Total bilirubin =< . X institutional upper limit of normal, unless there is a known history of Gilberts disease +Within days prior to signing consent: Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilberts syndrome) +Bilirubin > . x upper limit of normal (ULN) unless with Gilberts syndrome or +Bilirubin < . x upper limit of normal (ULN) (unless Gilberts is suspected)