[c09aa8]: / clusters / 9knumclustersv2 / clust_636.txt

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Patients must have normal organ and marrow function independent of transfusion for at least days prior to screening and independent of growth factor support for at least days prior to screening
REGISTRATION STEP -RANDOMIZATION: Patients who are transfusion-dependent and patients receiving growth factor support are eligible; patients must discontinue growth factor support prior to initiation of protocol therapy
Platelets >= x ^/L within days of treatment initiation and must be independent of hematopoietic growth factor support
Adequate hematologic function independent of transfusion and growth factor support for at least days prior to screening and randomization, with the exception of PEGylated granulocyte colony stimulating factor (GCSF) (pegfilgrastim) and darbepoetin which require at least days prior to screening and randomization
Platelet count >= ,/mm^; in the case that platelets are between , -,, the patient can be enrolled if the plasma cell count in the bone marrow is superior to >= %; to meet this hematological eligibility no transfusion support and hematological growth factor are not allowed within days before study enrollment
Acceptable hematologic status (without growth factor support or transfusion dependency):
Patients who have received neutrophil growth factor support within days of randomization.
STRATUM B: ANC >= to /mm^ without growth factor support within days of the test
STRATUM C: ANC >= ,/mm^ without growth factor support within days of the test
(* = without ongoing growth factor or transfusion support)
Patients must have adequate organ and bone marrow function within days prior to registration, as defined by: absolute neutrophil count >= ,/mcL, regardless of transfusion or growth factor support
Patients must have adequate organ and bone marrow function within days prior to registration, as defined by: platelets >= ,/mcl, regardless of transfusion or growth factor support
Platelet >= ,/mm^ without transfusion or growth factor support for at least week
Platelets >= ,/mcl; transfusion and/or growth factor are permitted within any timeframe
Hemoglobin > . g/dL independent of transfusion and growth factor support for at least days prior to screening (except for pegylated G-CSF [pegfilgrastim] and darbepoetin which require at least days prior to screening)
If the bone marrow evaluation shows heavy infiltration with underlying disease, growth factor support may be administered after screening and prior to the first dose of therapy
Platelets >= ,/mcl, regardless of transfusion or growth factor support
PHASE I: Platelets >= ,/mcL without growth factor support
PHASE II SCLC: Platelets >= ,/mcL without growth factor support
UROTHELIAL CARCINOMA EXPANSION COHORT: Platelets >= ,/mcL without growth factor support
mCRPC EXPANSION COHORT: Platelets >= ,/mcL without growth factor support
Bone marrow reserve consistent with: absolute neutrophil count (ANC) >= . x ^/L values must be obtained without the need for myeloid growth factor support, platelet or packed red blood cell (PRBC) transfusion support within days
Bone marrow reserve consistent with: platelet count >= x /L values must be obtained without the need for myeloid growth factor support, platelet or PRBC transfusion support within days
White blood cell >= , cells/ul without growth factor support
Current or planned growth factor or transfusion support until after initiation of treatment; if growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible
Platelets >= ,/uL (without transfusion or growth factor support), performed within days prior to registration
Values must be obtained without need for myeloid growth factor or platelet transfusion support within days of registration; however, erythrocyte growth factor is allowed as per published American Society of Clinical Oncology (ASCO) guidelines
Platelets > K without growth factor or transfusion support for a week at least
NOTE: white blood count and platelet count criteria must be met without any transfusion or growth factor support
Adequate hematologic function independent of growth factor support for at least days prior to screening and randomization, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which cannot be administered within days of screening
Platelets >= ,/mm^ (without transfusion or growth factor support)
Patients must have normal organ and marrow function as defined below, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least days prior to first dose of study drug, with the exception of pegylated granulocyte-colony stimulating factor (G-CSF) (pegfilgrastim) and darbepoetin which require at least days prior to screening and randomization
Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)
ANC ?/mm (?. /L) without growth factor support for days
Laboratory results within days prior to MRZ administration (transfusions and/or growth factor support may not be used to meet this criteria):
Adequate hematologic function without growth factor or transfusion support
Prior therapy with growth factor support, lenalidomide, -azacytidine, decitabine or other investigational agents are allowed; a four week wash out period will be required before receiving study medication
Patients who have received hematopoietic growth factor support within days of day of SGN-
(* = without ongoing growth factor or transfusion support)
Growth factor or cytokine support
Adequate marrow function independent of growth factor or transfusion support within weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
Hematologic(These values must be independent of growth factor support and stable for at least one week post transfusion)
Serum bilirubin <=. x upper limit of normal (ULN)( These values must be independent of growth factor support and stable for at least one week post transfusion)
Patients must have normal organ and marrow function, independent of transfusion or growth factor support within days before enrollment; patients should not receive growth factors or transfusions for at least days prior to the first dose of study drug, with the exception of pegylated GCSF (pegfilgrastim) and darbepoetin, which require at least days prior to screening and enrollment
Platelets >= ^/L; if the bone marrow contains >= % plasma cells, a platelet count of >= ^/L is allowed (without transfusion support and without hematological growth factor support within weeks of cycle day )
Growth factor or cytokine support;
Platelet count >= x ^/L. No transfusion or growth factor support for one week prior to labs.
Patients must have normal organ and marrow function, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoeitin which require at least days prior to screening and randomization
Patients must have acceptable organ and marrow function, which should be present independent of growth factor or transfusion support for at least days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbopoeitin which require a -day period between dosing and first dose of study drug
Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
Neutrophils >= . x ^/L (growth factor support is not allowed), within days prior to registration
Adequate bone marrow function without transfusion or growth factor support, defined as:
Acceptable hematologic status (without growth factor support for neutropenia or transfusion dependency):
Adequate hematologic function independent of transfusion and growth factor support for at least days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least days prior to screening), defined as:
ANC > /mm, platelets > ,/mm, Hgb > g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within days, however, erythrocyte growth factor is allowed as per published ASCO guidelines.
Growth factor/cytokine support;
Platelets >= ,/ul without growth factor or transfusional support
Platelets >= ,/ul without growth factor or transfusional support
Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)
Subjects with myelodysplastic syndrome who have not been treated previously with -azacytidine or decitabine are eligible, regardless of International Prognostic Scoring System risk score; subjects may have received transfusion support, growth factor support, or lenalidomide as previous therapy; however, they shall not have received growth factor support or lenalidomide within weeks of study enrollment