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a b/clusters/3009knumclusters/clust_206.txt
1
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
2
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
3
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
4
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
5
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
6
Patient must not have an antecedent hematologic disorder
7
Adequate hematologic, hepatic, and renal function
8
Subject must have adequate hematologic, renal and hepatic function.
9
Adequate hematologic function
10
Participants must have adequate hematologic, renal and hepatic function.
11
Acceptable hematologic status:
12
Acceptable hematologic status:
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Adequate hematologic function
14
Adequate hepatic, renal, cardiac, and hematologic function
15
Poor hematologic, renal, or hepatic function
16
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
17
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
18
Acceptable hematologic status
19
Adequate hematologic, renal, and hepatic parameters
20
Hematologic function: Adequate bone marrow function is defined as:
21
Acceptable liver, renal, hematologic and coagulation function
22
Adequate hematologic, renal, and hepatic function
23
Adequate hematologic, hepatic, and renal function.
24
adequate hematologic, renal and hepatic function
25
Inadequate hematologic function as evidenced by any of the following:
26
Adequate hematologic function within 28 days prior to study registration defined as meeting all of the following criteria:
27
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
28
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.
29
Adequate hematologic, renal, and liver function
30
Participants with hematologic malignancies
31
Acceptable hematologic status at Screening
32
The patient has adequate baseline hematologic function, as demonstrated by the following:
33
Poor hematologic, renal, or hepatic function
34
Acceptable hematologic, renal and liver function as follows:
35
Adequate hematologic parameters unless clearly due to the disease under study
36
Adequate hematologic status
37
Hematologic malignancies other than lymphomas.
38
Inadequate hematologic, renal or hepatic function.
39
Adequate hepatic, renal, cardiac, and hematologic function.
40
Hematologic malignancies other than lymphomas.
41
Have adequate hematologic function within 15 days prior to study treatment, defined as meeting all of the following criteria:
42
Appropriate renal, liver, and hematologic lab values
43
Adequate hematologic, renal and hepatic laboratory parameters
44
Current hematologic malignancies.
45
Must have adequate hematologic, renal and hepatic function.
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Concurrent hematologic or non-hematologic malignancy requiring treatment
47
Adequate hematologic function
48
Germ cell or hematologic malignancies
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Adequate organ function as per Hematologic, Hepatic, Renal and Cardiac Laboratory Values
50
Hematologic malignancy
51
Adequate hematologic, hepatic, and renal function
52
Adequate hematologic parameters without ongoing transfusional support:
53
Subjects must have adequate hematologic, hepatic and renal function.
54
Adequate baseline hematologic, renal, and hepatic function
55
Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as defined by criteria below:
56
Hematologic (BM Function):
57
Hematologic (Coagulation Factors):
58
Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis)
59
Adequate hematologic parameters without ongoing transfusional support:
60
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
61
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
62
Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies
63
Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
64
Adequate hematologic, hepatic, and renal function
65
Acceptable hematologic status
66
Adequate baseline hematologic, renal, and hepatic function
67
Hematologic malignancies other than lymphomas.
68
Subject has adequate hematologic function and adequate hepatic function at screening
69
Patients must have adequate renal/hematologic function, as defined by creatinine clearance > 30ml/min and platelets>50,000.
70
Adequate hematologic, coagulation (INR 2-3 max), hepatic and renal function
71
Inadequate hematologic, coagulation (INR >3), hepatic, renal function
72
Adequate hematologic, renal and hepatic function
73
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):
74
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
75
Adequate hematologic parameters without ongoing transfusional support:
76
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
77
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:
78
Adequate hepatic, renal, cardiac, and hematologic function
79
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
80
Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma or secondary amyloidosis)
81
All patients enrolled on the study must be evaluable for hematologic toxicity
82
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
83
All patients enrolled on Part A of the study must be evaluable for hematologic toxicity
84
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
85
Adequate hematologic, renal, and hepatic function.
86
Untreated first hematologic relapse is defined as:
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Adequate hematologic, hepatic, renal, and coagulation function.
88
Has adequate hematologic (bone marrow and coagulation factors), renal and hepatic function as defined by criteria below:
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Hematologic (BM Function):
90
Hematologic (Coagulation Factors):
91
Adequate kidney and hematologic function assessed from baseline laboratory data
92
Participant must have adequate hematologic, renal, hepatic, and lung function.
93
Part 1: solid tumors or lymphomas, or hematologic malignancies
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Adequate hematologic, renal, and hepatic function (within 28 days of randomization).
95
Adequate hematologic, renal, and hepatic function
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Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
97
Adequate hematologic, renal, and hepatic function
98
Have adequate hematologic function.
99
Adequate hematologic function:
100
Adequate hematologic function
101
Acceptable hematologic status:
102
Diagnosis of any of the following hematologic malignancies:
103
Adequate hematologic, hepatic, and renal function
104
Inadequate hematologic, hepatic, or renal function
105
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
106
Adequate hematologic function
107
Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function
108
Adequate hematologic function
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Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests.
110
Has adequate hematologic (bone marrow and coagulation factors), renal, and hepatic function as defined by criteria below:
111
Inadequate hematologic function (unless due to underlying lymphoma)
112
Adequate hematologic, hepatic, and renal function
113
Adequate hematologic, liver, coagulation and kidney function
114
Hematologic and Non-hematologic exclusion criteria before start of therapy.
115
Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ? 7 days before treatment initiation.
116
Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)
117
Adequate hematologic function without growth factor or transfusion support
118
Adequate hematologic function:
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Adequate hematologic, renal and hepatic function, specifically:
120
Adequate renal, and hematologic function
121
Adequate hematologic function
122
Acceptable hematological status (without hematologic support
123
Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
124
Inadequate hematologic, renal, or hepatic function
125
Adequate hematologic, hepatic, renal, and coagulation functions
126
Adequate hematologic, hepatic, and renal function
127
Subject has adequate hematologic, hepatic, renal, and coagulation function
128
Adequate organ function as per pre-defined hematologic, hepatic, renal, and cardiac criteria.
129
Adequate baseline hematologic function, as demonstrated by the following:
130
Adequate hepatic, renal, cardiac, and hematologic function
131
Adequate hematologic status
132
Adequate hepatic, hematologic, and renal function
133
Inadequate hematologic or hepatic function
134
Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
135
Adequate hematologic function:
136
Adequate hematologic, hepatic, and renal function, defined by:
137
Adequate hematologic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
138
Adequate hematologic, hepatic, and renal function
139
Grossly normal pulmonary, cardiac function, renal, hepatic hematologic and performance functions
140
Adequate hematologic function as defined by:
141
Inadequate hematologic, renal or liver function
142
Adequate hematologic, renal and hepatic function.
143
Has adequate hematologic, hepatic, and renal function as defined by the protocol
144
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).
145
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
146
Inadequate hematologic, renal or liver function
147
Adequate hematologic, renal and liver function
148
Adequate hematologic, hepatic, renal and cardiac function.
149
Adequate hematologic, hepatic and renal function
150
Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
151
No significant hematologic abnormalities
152
Have adequate hematologic, hepatic, and renal function
153
Adequate hematologic function
154
Have adequate hematologic, hepatic and renal function
155
Adequate hematologic, hepatic and renal function.
156
Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
157
Have adequate hematologic function, defined as meeting all of the following criteria:
158
Adequate hematologic function within protocol-defined parameters.
159
Adequate hematologic function Arm A (except for CLL subjects with significant BM involvement by biopsy) must meet the following criteria:
160
Acceptable hematologic and organ function
161
Adequate hematologic, hepatic, and renal function
162
Has adequate hematologic, renal, cardiac and hepatic function.
163
Must have adequate hematologic, renal, and liver function
164
Adequate hematologic, hepatic, and renal function.
165
Subject has the following laboratory parameters at screening: Adequate hematologic function including:
166
Adequate hematologic, hepatic, cardiac, and renal function
167
Adequate hematologic, hepatic, and renal function.
168
Not adequate hematologic, renal and hepatic function
169
Adequate hematologic, renal, and hepatic function.
170
Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
171
Adequate hematologic, hepatic, renal function
172
Adequate hematologic function, as defined by the following criteria:
173
Subject must have adequate hematologic reserve
174
Poor hematologic, renal, or hepatic function
175
Adequate hematologic function.
176
Adequate hematologic, hepatic, and renal function:
177
Patient has any of the following hematologic parameters:
178
Adequate baseline hematologic, pulmonary, renal, and hepatic function
179
Adequate hematologic, kidney and liver function
180
Inadequate hematologic or biologic function as determined by the following laboratory tests:
181
Adequate hematologic, hepatic and renal function
182
Acceptable hematological status (without hematologic support
183
Patients must have normal organ and hematologic function therapy
184
Adequate hematologic function:
185
Adequate hematologic, renal and hepatic function
186
Adequate hematologic function defined by:
187
Adequate hematologic function
188
Adequate hematologic, liver, coagulation, renal, and cardiovascular function
189
Evidence of significant hepatic, hematologic, or immunologic disease.
190
Adequate hematologic, renal and hepatic function
191
Patients with any of the following hematologic abnormalities at baseline:
192
Inadequate hematologic, biochemical, and organ function
193
Subject must have adequate hematologic, renal and hepatic function as follows:
194
Antecedent hematologic disease
195
Adequate hematologic, hepatic and renal function
196
Inadequate hematologic, hepatic or renal function
197
Patients with any of the following hematologic abnormalities at baseline:
198
Hematologic:
199
Hematologic function, as follows:
200
Hematologic status:
201
Adequate hepatic, renal, cardiac and hematologic function
202
Adequate hematologic, hepatic and renal function as defined by laboratory assessment
203
Adequate hematologic, renal and liver function
204
Inadequate hematologic, liver, or renal function
205
Adequate hematologic, liver, and renal function
206
Hematologic, liver, and renal function as specified in the study protocol.
207
Has adequate hematologic, liver, and renal function
208
Adequate hematologic, renal, and liver functions
209
Adequate hematologic and renal function as determined by laboratory blood and urine tests
210
Has adequate hematologic, coagulation, hepatic and renal function
211
Hematologic parameters defined by:
212
Adequate hematologic function.
213
Inadequate hematologic function as evidenced by any of the following:
214
Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician
215
Participants with adequate hematologic, hepatic, and renal function.
216
Participant must have adequate hematologic, renal, and hepatic function.
217
Hematologic malignancy
218
Adequate hematologic function as indicated by:
219
Patient has adequate hematologic, hepatic, and renal function as defined by:
220
Any of the following hematologic malignancies:
221
Any of the following hematologic malignancies:
222
Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction
223
Adequate hepatic, renal, cardiac, and hematologic function
224
Adequate hematologic, hepatic, and renal function, as evidenced by:
225
Adequate hematologic, hepatic, and renal function
226
Adequate hematologic, hepatic, and renal function.
227
Patient has adequate hematologic, hepatic, and renal functions
228
Adequate hematologic, immunologic, liver and renal function, defined as