[c09aa8]: / clusters / clustall9k / 73.txt

Download this file

147 lines (146 with data), 9.2 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
Other protocol defined inclusion criteria could apply.
Other protocol defined exclusion criteria could apply.
ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Other protocol defined inclusion criteria could apply
Other protocol defined exclusion criteria could apply
History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Other protocol-defined inclusion/exclusion criteria.
Pregnant, Other protocol-defined inclusion/exclusion criteria may apply
Other protocol defined exclusion criteria could apply
Other protocol-defined inclusion/exclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Major surgery: ?2 weeks Other protocol defined inclusion/exclusion may apply.
Other protocol defined inclusion criteria could apply
Other protocol defined exclusion criteria could apply
Other protocol defined inclusion criteria could apply
Other protocol defined exclusion criteria could apply
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Others as defined in the protocol
Others as defined in the protocol
Other protocol defined exclusion criteria could apply
Other protocol defined inclusion criteria could apply
Other protocol defined exclusion criteria could apply
Other protocol defined inclusion criteria may apply.
Other protocol defined exclusion criteria may apply.
Other protocol-defined inclusion/exclusion criteria may apply.
Other protocol defined criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
Other protocol defined inclusion criteria could apply
Other protocol defined exclusion criteria could apply
Other Protocol defined Inclusion/Exclusion may apply.
Procurement: Patients with life expectancy >= 6 months
Procurement: Patients with active human immunodeficiency virus (HIV) infection (can be pending at this time)
>= 3 weeks from protocol tissue procurement since treatment (surgery, chemo-, radiation-, hormone- therapy, check point blockade [e.g., anti-CTLA-4, PD-1, PDL-1]); (windows are in relation to the date of the protocol tissue procurement)
PROCUREMENT: Patient able to give informed consent
PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw)
INCLUSION CRITERIA FOR BLOOD PROCUREMENT:
EXCLUSION CRITERIA FOR BLOOD PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA: Patients with life expectancy ? 12 weeks
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
PROCUREMENT EXCLUSION CRITERIA: Patients with active human immunodeficiency virus (HIV) infection at time of procurement
INCLUSION - PROCUREMENT: If pheresis required to collect blood:\r\n* Creatinine <1.5 × upper limit normal
INCLUSION - PROCUREMENT: EBV positive tumor (can be pending)
INCLUSION - PROCUREMENT: Weighs at least 12 kg
PROCUREMENT INCLUSION: Diagnosis of relapsed/refractory HL or NHL
PROCUREMENT INCLUSION CRITERIA: Patients with life expectancy ? 6 weeks
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
PROCUREMENT EXCLUSION CRITERIA: Patients with active human immunodeficiency virus (HIV) infection at time of procurement (can be pending at the time of blood draw)
PROCUREMENT EXCLUSION CRITERIA: Patients in remission who are enrolled on another study where time to progression or disease free survival is a primary endpoint
PROCUREMENT CRITERIA
CELL PROCUREMENT: Life expectancy >= 12 weeks
CELL PROCUREMENT: Bilirubin =< 1.5 x upper limit of normal (ULN), unless attributed to Gilbert’s syndrome, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Aspartate aminotransferase (AST) =< 3.0 x ULN, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Alanine aminotransferase (ALT) =< 3.0 x ULN, obtained within 72 hrs prior to procurement
CELL PROCUREMENT: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to procurement is left to the discretion of the investigator; maintenance doses of chemotherapy are defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; corticosteroid-containing maintenance therapy is permitted only if corticosteroids are administered > 14 days prior to procurement; (Note: corticosteroid use with doses at the discretion of the treating physician are allowed after procurement up to the beginning of lymphodepletion; corticosteroid use is contraindicated following iC9-CAR19 infusion unless medically necessary e.g., to treat CRS)
CELL PROCUREMENT: Received anti-CD19 antibody-based therapy OR cytotoxic chemotherapy not described as maintenance therapy within 2 weeks of procurement
PRIOR TO CELL PROCUREMENT: Serum creatinine ? 1.5 times ULN
PRIOR TO CELL PROCUREMENT: Negative serum pregnancy test in females within 72 hours prior to procurement or documentation that the subject is post-menopausal or premenarchal
PRIOR TO CELL PROCUREMENT: Pregnant or lactating
AT THE TIME OF PROCUREMENT: Recurrent or refractory GBM
AT THE TIME OF PROCUREMENT: Subjects having a tumor resection
AT THE TIME OF PROCUREMENT: Karnofsky score of ? 60
PROCUREMENT: Karnofsky score ? 50%
PROCUREMENT: Diagnosis of myeloma after receiving at least one treatment regimen
PROCUREMENT: Patient able to give informed consent
PROCUREMENT: Patients with severe active infection
PROCUREMENT: Patients with active human immunodeficiency virus (HIV) infection at time of procurement (can be pending at the time of blood draw)
INCLUSION CRITERIA AT TIME OF PROCUREMENT:
EXCLUSION CRITERIA AT TIME OF PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA:
PROCUREMENT EXCLUSION CRITERIA:
PROCUREMENT ELIGIBILITY:
PROCUREMENT ELIGIBILITY:
AT TIME OF PROCUREMENT:
AT TIME OF PROCUREMENT:
PROCUREMENT INCLUSION CRITERIA:
PROCUREMENT EXCLUSION CRITERIA:
AT THE TIME OF PROCUREMENT: Nasopharyngeal carcinoma in first or subsequent relapse or with primary refractory disease
AT THE TIME OF PROCUREMENT: EBV positive tumor
Patients must have an accessible metastatic lesion for pretreatment core biopsy procurement.
ELIGIBILITY FOR BLAST COLLECTION (PROCUREMENT)
Procurement consent signed and faxed to Research Coordinator
Additional criteria may apply. MELANOMA (pembrolizumab only)
Additional criteria may apply
Other Inclusion Criteria May Apply.
Further inclusion criteria apply
Other inclusion criteria may apply
Additional cohort-specific criteria may apply.
Further inclusion criteria apply
Subject must be able to provide an evaluable core or excisional biopsy prior to the start of treatment. Other Inclusion Criteria May Apply
Other inclusion criteria may apply
Other inclusion criteria apply.
Other inclusion criteria may apply
Further Inclusion criteria apply
Further inclusion criteria apply.
Further inclusion criteria apply.
Additional criteria may apply.
Additional criteria may apply.
Other exclusions apply
Additional criteria apply, please contact the investigator for more information
Additional criteria apply, please contact the investigator for more information
Additional criteria may apply
Additional criteria may apply
Other inclusion criteria may apply
Other criteria apply.
Other criteria apply.
Other inclusion criteria may apply
Patients unable to apply Estring
Other Inclusion Criteria May Apply
Criteria 10, Other Inclusion Criteria May Apply.
Other Inclusion Criteria May Apply
Other criteria may apply, please contact the investigator for additional information
Other criteria may apply, please contact the investigator for additional information
Additional inclusion criteria exist
Additional exclusion criteria exist
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
Additional criteria exist.
ADDITIONAL CRITERIA
No additional restrictions exist regarding co-morbid disease or incurrent illness
Further exclusion criteria apply
Other Exclusion Criteria May Apply.
Further exclusion criteria apply
COHORT A: All other inclusion and exclusion criteria apply
Other exclusion criteria may apply
Other exclusion criteria may apply
Other exclusion criteria may apply
Further Exclusion criteria apply
Further exclusion criteria apply.
Further exclusion criteria apply
Further exclusion criteria apply
Other exclusion criteria may apply
Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply
Other Exclusion Criteria May Apply
Criteria 7, Other Exclusion Criteria May Apply
Other Exclusion Criteria May Apply