[c09aa8]: / clusters / 3009knumclusters / clust_206.txt

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Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity, for Parts A and C; if dose-limiting hematologic toxicity is observed on either Part A or C, all subsequent patients enrolled must be evaluable for hematologic toxicity on that Part
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study if they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity for Part A, the dose escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients on Part A1 must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Patient must not have an antecedent hematologic disorder
Adequate hematologic, hepatic, and renal function
Subject must have adequate hematologic, renal and hepatic function.
Adequate hematologic function
Participants must have adequate hematologic, renal and hepatic function.
Acceptable hematologic status:
Acceptable hematologic status:
Adequate hematologic function
Adequate hepatic, renal, cardiac, and hematologic function
Poor hematologic, renal, or hepatic function
Absolute neutrophil count (ANC) >= 750/uL for subjects with bone marrow involvement; these subjects will not be evaluable for hematologic toxicity or hematologic dose limiting toxicity (DLT), but will be subject to dose modifications based on hematologic criteria
Platelet count >= 75,000/uL (platelet transfusions allowed provided the patient is not known to be refractory to red cell or platelet transfusions) for subjects with bone marrow involvement; these subjects will not be evaluable for hematologic toxicity or hematologic DLT, but will be subject to dose modifications based on hematologic criteria
Acceptable hematologic status
Adequate hematologic, renal, and hepatic parameters
Hematologic function: Adequate bone marrow function is defined as:
Acceptable liver, renal, hematologic and coagulation function
Adequate hematologic, renal, and hepatic function
Adequate hematologic, hepatic, and renal function.
adequate hematologic, renal and hepatic function
Inadequate hematologic function as evidenced by any of the following:
Adequate hematologic function within 28 days prior to study registration defined as meeting all of the following criteria:
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts specified above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity.
Adequate hematologic, renal, and liver function
Participants with hematologic malignancies
Acceptable hematologic status at Screening
The patient has adequate baseline hematologic function, as demonstrated by the following:
Poor hematologic, renal, or hepatic function
Acceptable hematologic, renal and liver function as follows:
Adequate hematologic parameters unless clearly due to the disease under study
Adequate hematologic status
Hematologic malignancies other than lymphomas.
Inadequate hematologic, renal or hepatic function.
Adequate hepatic, renal, cardiac, and hematologic function.
Hematologic malignancies other than lymphomas.
Have adequate hematologic function within 15 days prior to study treatment, defined as meeting all of the following criteria:
Appropriate renal, liver, and hematologic lab values
Adequate hematologic, renal and hepatic laboratory parameters
Current hematologic malignancies.
Must have adequate hematologic, renal and hepatic function.
Concurrent hematologic or non-hematologic malignancy requiring treatment
Adequate hematologic function
Germ cell or hematologic malignancies
Adequate organ function as per Hematologic, Hepatic, Renal and Cardiac Laboratory Values
Hematologic malignancy
Adequate hematologic, hepatic, and renal function
Adequate hematologic parameters without ongoing transfusional support:
Subjects must have adequate hematologic, hepatic and renal function.
Adequate baseline hematologic, renal, and hepatic function
Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as defined by criteria below:
Hematologic (BM Function):
Hematologic (Coagulation Factors):
Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis)
Adequate hematologic parameters without ongoing transfusional support:
Patients with solid tumors metastatic to bone marrow will be eligible for study but not evaluable for hematologic toxicity; these patients must not be known to be refractory to red cell or platelet transfusions; at least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity; if dose limiting hematologic toxicity is observed at any dose level, all subsequent patients enrolled must be evaluable for hematologic toxicity
Subjects with known bone marrow metastatic disease will be eligible for study provided they meet the specified blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these subjects will not be evaluable for hematologic toxicity; if dose-limiting hematologic toxicity is observed, all subsequent subjects enrolled must be evaluable for hematologic toxicity
Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies
Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
Adequate hematologic, hepatic, and renal function
Acceptable hematologic status
Adequate baseline hematologic, renal, and hepatic function
Hematologic malignancies other than lymphomas.
Subject has adequate hematologic function and adequate hepatic function at screening
Patients must have adequate renal/hematologic function, as defined by creatinine clearance > 30ml/min and platelets>50,000.
Adequate hematologic, coagulation (INR 2-3 max), hepatic and renal function
Inadequate hematologic, coagulation (INR >3), hepatic, renal function
Adequate hematologic, renal and hepatic function
Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Adequate hematologic parameters without ongoing transfusional support:
Adequate bone marrow function defined as:\t\r\n* Subjects with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these subjects will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent subjects enrolled must be evaluable for hematologic toxicity
Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
Adequate hepatic, renal, cardiac, and hematologic function
Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria; patients with marrow disease are not evaluable for hematologic toxicity
Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma or secondary amyloidosis)
All patients enrolled on the study must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity, for the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
All patients enrolled on Part A of the study must be evaluable for hematologic toxicity
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
Adequate hematologic, renal, and hepatic function.
Untreated first hematologic relapse is defined as:
Adequate hematologic, hepatic, renal, and coagulation function.
Has adequate hematologic (bone marrow and coagulation factors), renal and hepatic function as defined by criteria below:
Hematologic (BM Function):
Hematologic (Coagulation Factors):
Adequate kidney and hematologic function assessed from baseline laboratory data
Participant must have adequate hematologic, renal, hepatic, and lung function.
Part 1: solid tumors or lymphomas, or hematologic malignancies
Adequate hematologic, renal, and hepatic function (within 28 days of randomization).
Adequate hematologic, renal, and hepatic function
Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
Adequate hematologic, renal, and hepatic function
Have adequate hematologic function.
Adequate hematologic function:
Adequate hematologic function
Acceptable hematologic status:
Diagnosis of any of the following hematologic malignancies:
Adequate hematologic, hepatic, and renal function
Inadequate hematologic, hepatic, or renal function
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ? 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply
Adequate hematologic function
Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function
Adequate hematologic function
Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests.
Has adequate hematologic (bone marrow and coagulation factors), renal, and hepatic function as defined by criteria below:
Inadequate hematologic function (unless due to underlying lymphoma)
Adequate hematologic, hepatic, and renal function
Adequate hematologic, liver, coagulation and kidney function
Hematologic and Non-hematologic exclusion criteria before start of therapy.
Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ? 7 days before treatment initiation.
Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)
Adequate hematologic function without growth factor or transfusion support
Adequate hematologic function:
Adequate hematologic, renal and hepatic function, specifically:
Adequate renal, and hematologic function
Adequate hematologic function
Acceptable hematological status (without hematologic support
Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
Inadequate hematologic, renal, or hepatic function
Adequate hematologic, hepatic, renal, and coagulation functions
Adequate hematologic, hepatic, and renal function
Subject has adequate hematologic, hepatic, renal, and coagulation function
Adequate organ function as per pre-defined hematologic, hepatic, renal, and cardiac criteria.
Adequate baseline hematologic function, as demonstrated by the following:
Adequate hepatic, renal, cardiac, and hematologic function
Adequate hematologic status
Adequate hepatic, hematologic, and renal function
Inadequate hematologic or hepatic function
Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
Adequate hematologic function:
Adequate hematologic, hepatic, and renal function, defined by:
Adequate hematologic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
Adequate hematologic, hepatic, and renal function
Grossly normal pulmonary, cardiac function, renal, hepatic hematologic and performance functions
Adequate hematologic function as defined by:
Inadequate hematologic, renal or liver function
Adequate hematologic, renal and hepatic function.
Has adequate hematologic, hepatic, and renal function as defined by the protocol
Adequate hematologic, hepatic, and renal function (absolute neutrophil count ?1.5x 109/L, Hgb >10 g/dL, platelet count ?100 x 109/L, AST/ALT ?2.5x ULN, creatinine ?1.5x ULN).
Patients with lymphoma metastatic to bone marrow who have granulocytopenia, anemia, and/or thrombocytopenia will be eligible for study but not evaluable for hematologic toxicity (in Part A, there will be a maximum of one per cohort); such patients must meet the blood counts as in Part A (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled in Part A must be evaluable for hematologic toxicity
Inadequate hematologic, renal or liver function
Adequate hematologic, renal and liver function
Adequate hematologic, hepatic, renal and cardiac function.
Adequate hematologic, hepatic and renal function
Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
No significant hematologic abnormalities
Have adequate hematologic, hepatic, and renal function
Adequate hematologic function
Have adequate hematologic, hepatic and renal function
Adequate hematologic, hepatic and renal function.
Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Have adequate hematologic function, defined as meeting all of the following criteria:
Adequate hematologic function within protocol-defined parameters.
Adequate hematologic function Arm A (except for CLL subjects with significant BM involvement by biopsy) must meet the following criteria:
Acceptable hematologic and organ function
Adequate hematologic, hepatic, and renal function
Has adequate hematologic, renal, cardiac and hepatic function.
Must have adequate hematologic, renal, and liver function
Adequate hematologic, hepatic, and renal function.
Subject has the following laboratory parameters at screening: Adequate hematologic function including:
Adequate hematologic, hepatic, cardiac, and renal function
Adequate hematologic, hepatic, and renal function.
Not adequate hematologic, renal and hepatic function
Adequate hematologic, renal, and hepatic function.
Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
Adequate hematologic, hepatic, renal function
Adequate hematologic function, as defined by the following criteria:
Subject must have adequate hematologic reserve
Poor hematologic, renal, or hepatic function
Adequate hematologic function.
Adequate hematologic, hepatic, and renal function:
Patient has any of the following hematologic parameters:
Adequate baseline hematologic, pulmonary, renal, and hepatic function
Adequate hematologic, kidney and liver function
Inadequate hematologic or biologic function as determined by the following laboratory tests:
Adequate hematologic, hepatic and renal function
Acceptable hematological status (without hematologic support
Patients must have normal organ and hematologic function therapy
Adequate hematologic function:
Adequate hematologic, renal and hepatic function
Adequate hematologic function defined by:
Adequate hematologic function
Adequate hematologic, liver, coagulation, renal, and cardiovascular function
Evidence of significant hepatic, hematologic, or immunologic disease.
Adequate hematologic, renal and hepatic function
Patients with any of the following hematologic abnormalities at baseline:
Inadequate hematologic, biochemical, and organ function
Subject must have adequate hematologic, renal and hepatic function as follows:
Antecedent hematologic disease
Adequate hematologic, hepatic and renal function
Inadequate hematologic, hepatic or renal function
Patients with any of the following hematologic abnormalities at baseline:
Hematologic:
Hematologic function, as follows:
Hematologic status:
Adequate hepatic, renal, cardiac and hematologic function
Adequate hematologic, hepatic and renal function as defined by laboratory assessment
Adequate hematologic, renal and liver function
Inadequate hematologic, liver, or renal function
Adequate hematologic, liver, and renal function
Hematologic, liver, and renal function as specified in the study protocol.
Has adequate hematologic, liver, and renal function
Adequate hematologic, renal, and liver functions
Adequate hematologic and renal function as determined by laboratory blood and urine tests
Has adequate hematologic, coagulation, hepatic and renal function
Hematologic parameters defined by:
Adequate hematologic function.
Inadequate hematologic function as evidenced by any of the following:
Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician
Participants with adequate hematologic, hepatic, and renal function.
Participant must have adequate hematologic, renal, and hepatic function.
Hematologic malignancy
Adequate hematologic function as indicated by:
Patient has adequate hematologic, hepatic, and renal function as defined by:
Any of the following hematologic malignancies:
Any of the following hematologic malignancies:
Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction
Adequate hepatic, renal, cardiac, and hematologic function
Adequate hematologic, hepatic, and renal function, as evidenced by:
Adequate hematologic, hepatic, and renal function
Adequate hematologic, hepatic, and renal function.
Patient has adequate hematologic, hepatic, and renal functions
Adequate hematologic, immunologic, liver and renal function, defined as