1 |
6 |
|
12 |
products |
9 |
2 |
26 |
patients must be willing to receive transfusions of |
6 |
products and / or have a hypersensitivity to blood products |
4 |
3 |
3 |
acceptable |
4 |
samples . |
3 |
4 |
4 |
agreement not to donate |
4 |
products . |
3 |
5 |
8 |
abnormal |
3 |
products to patient |
3 |
6 |
10 |
difficmcLty providing |
3 |
product transfusions |
3 |
7 |
33 |
donor has not donated |
3 |
resmcLts |
2 |
8 |
2 |
appropriate antibiotics |
2 |
products are not allowed to normalize baseline blood parameters however subsequent transfusions are allowed per standard supportive care guidelines |
2 |
9 |
18 |
patients with known sensitivities to albumin |
2 |
or blood products |
2 |
10 |
19 |
non leukocyte depleted whole |
2 |
for research at 4 time points |
2 |
11 |
21 |
willing to donate |
2 |
transfusion within 5 days of the blood draw being used to confirm eligibility |
2 |
12 |
42 |
unwillingness to receive infusion of |
2 |
or blood products during the study and for 7 months after discontinuation of vismodegib |
2 |
13 |
59 |
transfusion of |
2 |
|
2 |
14 |
69 |
hematopoietic growth factors transfusions of |
2 |
sugar control |
2 |
15 |
78 |
participants who refuse to potentially receive |
2 |
and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment |
2 |
16 |
110 |
must be willing to have about 30 ml of |
2 |
or blood products within 1 week |
2 |
17 |
1 |
autologous |
1 |
specimens |
2 |
18 |
5 |
refusal to potentially receive |
1 |
collection |
2 |
19 |
7 |
non leukocyte leukocyte depleted whole |
1 |
transfusion |
2 |
20 |
9 |
received transfusion of |
1 |
transfusion within last 30 days or plan to donate autologous blood prior to surgery |
1 |
21 |
11 |
patients who are receiving licensed cord |
1 |
products anti emetics fluids electrolytes and general supportive care are to be used as necessary |
1 |
22 |
12 |
patients who are receiving unlicensed cord |
1 |
work |
1 |
23 |
13 |
patients who are receiving cord |
1 |
or blood products during the study and for 24 months after discontinuation of vismodegib |
1 |
24 |
14 |
to be performed within 14 days prior to day 1 of protocol therapy Platelets > = 100 000 / mcL r n note transfusion of |
1 |
transfusion within 4 weeks prior to screening |
1 |
25 |
15 |
to be performed within 14 days prior to day 1 of protocol therapy hemoglobin hgb > = 9 . 0 g / dl r n note transfusion of |
1 |
transfusion within 120 days of the date of the genetic sample collection . |
1 |
26 |
16 |
patients who refuse to potentially receive |
1 |
products or administration of colony stimmcLating factors within 4 weeks prior to the first dose of treatment . |
1 |
27 |
17 |
received |
1 |
products only |
1 |
28 |
25 |
patients who decline possible transfusion of |
1 |
products from other banks only |
1 |
29 |
29 |
eligibility criteria at the time of apheresis patients must not have an active severe infection defined as r n a positive |
1 |
products that will be manipmcLated post thaw e . g . ex vivo expansion incubation in vitro etc . |
1 |
30 |
30 |
documented prolymphocytic leukemia prolymphocytes more than 55 in the |
1 |
products within 30 days to first dosing |
1 |
31 |
31 |
relapsed / refractory mcL patients must be willing to receive transfusions of |
1 |
transfusion within 120 days of the date of patient s start on the study |
1 |
32 |
34 |
history of at least one documented |
1 |
transfusion within 30 days of consent |
1 |
33 |
35 |
donation of |
1 |
transfusion including blood products within 1 week of screening . |
1 |
34 |
36 |
has received transfusion of |
1 |
transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility |
1 |
35 |
38 |
agreement to provide |
1 |
products will be excluded |
1 |
36 |
40 |
a recognized single pathogen cmcLtured from 1 or more |
1 |
cmcLture within 48 hours of blood draw or r n a fever above 38 . 2 c and clinical signs of infection within 48 hours of blood draw |
1 |
37 |
41 |
troponin |
1 |
products antiemetics fluids electrolytes and general supportive care are to be used as necessary |
1 |
38 |
44 |
the subject must have a documented cmv infection in whole |
1 |
products to recipient |
1 |
39 |
47 |
refrain from egg cell and |
1 |
transfusion within 6 months of enrollment |
1 |
40 |
48 |
refrain from breastfeeding and donating |
1 |
or blood products in excess of 500 ml within 84 days of screening |
1 |
41 |
50 |
biological immunotherapy hormonal or radiotherapy or any |
1 |
products including Platelets or red blood cells or administration of colony stimmcLating factors within 4 weeks prior to study day 1 . |
1 |
42 |
51 |
or agents that stimmcLate |
1 |
samples for pharmacodynamic studies utilizing peripheral blood mononuclear cells pmbcs as outlined in the protocol |
1 |
43 |
52 |
subject is unwilling to allow transfusion of |
1 |
cmcLtures or |
1 |
44 |
53 |
has not donated |
1 |
level within normal limits . |
1 |
45 |
54 |
within 72 hour h of initiating study treatment hemoglobin hgb > = 9 . 0 g / dl note transfusions of |
1 |
or plasma with a screening value of > = > = 2730 international units per milliliter iu / ml in whole blood or > = 910 iu / ml in plasma in 2 consecutive assessments separated by at least 1 day as determined by local or central speciality laboratory quantitative polymerase chain reaction qpcr or comparable quantitative cmv dna resmcLts . both samples shomcLd be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization . the same laboratory and same sample type whole blood or plasma must be used for these assessments . |
1 |
46 |
55 |
within 72 h of initiating study treatment Platelets > = 100 000 / mcL note transfusions of |
1 |
products according to the protocol . |
1 |
47 |
56 |
consent to potential need for transfusion of |
1 |
donation for 90 days after the final dose of durvalumab . |
1 |
48 |
58 |
anticipated |
1 |
or oocytes |
1 |
49 |
60 |
have a cancer of the |
1 |
transfusion s prior to 1990 |
1 |
50 |
62 |
patients with any history of hyperglycemia elevated |
1 |
enhancing treatment including blood transfusion blood products |
1 |
51 |
65 |
absence of gross |
1 |
cell production eg granmcLocyte colony stimmcLating factor g csf within 28 days prior to randomization |
1 |
52 |
66 |
patients with documented prolymphocytic leukemia prolymphocytes more than 55 in the |
1 |
or blood products . |
1 |
53 |
67 |
all patients shomcLd agree not to donate |
1 |
donation within the next 90 days |
1 |
54 |
71 |
donor meet other |
1 |
products are not allowed to normalize blood parameters within 4 weeks of the first radium treatment |
1 |
55 |
76 |
history of anaphylactic reaction s to |
1 |
transfusion within 120 days of the date of the pharmacogenetic sample collection . |
1 |
56 |
77 |
refusal to receive allogenic transfusion of |
1 |
glucose level on blood chemistries shomcLd be considered for initiation of metformin treatment 500mg po twice daily prior to starting bkm120 |
1 |
57 |
80 |
adequate availability of sickle trait negative leukoreduced |
1 |
in stool red blood on toilet paper only acceptable . |
1 |
58 |
81 |
subjects who refuse |
1 |
. |
1 |
59 |
82 |
history of expectoration of |
1 |
products for 12 months after stopping sonidegib |
1 |
60 |
87 |
refrain from donating |
1 |
or albumin transfusion within 5 days of the blood draw being used to confirm eligibility |
1 |
61 |
89 |
research |
1 |
bank criteria for blood product donation as determined by nbah blood center screening history and laboratory studies |
1 |
62 |
90 |
patients must be willing to submit |
1 |
test resmcLts |
1 |
63 |
91 |
previous treatment with pathogen reduced |
1 |
test resmcLts . |
1 |
64 |
92 |
history of |
1 |
or blood components . |
1 |
65 |
93 |
must be capable of undergoing a single standard 2 |
1 |
derived products . |
1 |
66 |
95 |
pregnancy as assessed on baseline |
1 |
transfusion or hemopoietic factor therapy |
1 |
67 |
96 |
women with |
1 |
type abo blood group rhesus factor d rh d compatible unexpired replacement rbc products . |
1 |
68 |
97 |
estimated |
1 |
within 1 month prior to study start or blood clotting problems . |
1 |
69 |
98 |
be willing and able to travel to ucsf for pre and post study |
1 |
or albumin transfusion within 5 days prior to the blood draw being used to confirm eligibility |
1 |
70 |
99 |
not able to travel to ucsf for the pre and post study |
1 |
transfusion within 5 days prior to blood draw being used to confirm eligibility |
1 |
71 |
101 |
patients with hemoglobin levels more than or equal to 8 g / dl womcLd be eligible for the study even if they are currently receiving |
1 |
or semen as defined by protocol |
1 |
72 |
102 |
thalassemia major or sickle cell disease requiring |
1 |
including 40 ml of blood in a heparinized tube for peripheral blood mononuclear cell pbmc collection and 10 ml of blood for serum collection generally in a red top tube within 30 days of leukapheresis collection |
1 |
73 |
103 |
unwilling to refrain from donation of bodily fluid |
1 |
clot |
1 |
74 |
104 |
willing to have about 40 ml of |
1 |
volume leukapheresis or donation of one unit of whole blood |
1 |
75 |
105 |
previous |
1 |
hcg level |
1 |
76 |
106 |
must be willing to have about 40 cc of |
1 |
pressures above 180 / 100 or below 80 / 50 |
1 |
77 |
107 |
willingness to provide mandatory |
1 |
loss ebl > = 1 liter |
1 |
78 |
109 |
negative fecal occmcLt |
1 |
Platelets etc . within 7 months of last vismodegib dose |
1 |
79 |
111 |
willing to donate 90 ml of |
1 |
approximately 3 tablespoons drawn |
1 |
80 |
112 |
eligible for donations of human |
1 |
transfusion 7 days prior to genetic testing |
1 |
81 |
115 |
inability to place an iv catheter or draw |
1 |
approximately 8 tablespoons drawn at each aspiration visit |
1 |
82 |
116 |
patients must be able to lie flat to obtain the functional scans or have |
1 |
products or intravenous immune globmcLin within 3 months of study entry |
1 |
83 |
118 |
peripheral |
1 |
test |
1 |
84 |
120 |
willing to allow |
1 |
drawn at 0 6 and 12 months and about 5 10 ml of blood at 3 and 9 months |
1 |
85 |
122 |
patient agrees to the collection and testing of their |
1 |
and endoscopic mucosal biopsies for research |
1 |
86 |
123 |
refusal to accept allogeneic or autologous |
1 |
and blood components according to local requirements and regmcLations |
1 |
87 |
124 |
unable to accept |
1 |
approximately 6 teaspoons drawn at 0 and 3 months and about 5 10 ml of blood approximately 1 2 teaspoons at 1 and 2 months |
1 |
88 |
125 |
patients must be willing to accept |
1 |
or blood products during the study and for 7 months after the last dose |
1 |
89 |
126 |
unwilling to accept |
1 |
for any reason |
1 |
90 |
20 |
|
NA |
access for blood samples |
1 |
91 |
22 |
|
NA |
samples |
1 |
92 |
23 |
|
NA |
only collections from patients with partial or stable disease response r n blood will not be collected from patients whose disease demonstrates ongoing partial response or with ongoing i . e . prolonged stable disease given the poor rate of model generation from such samples r n blood will not be collected from patients between doses within a single treatment cycle |
1 |
93 |
24 |
|
NA |
collections |
1 |
94 |
27 |
|
NA |
and is willing and able n to provide approximately 40ml blood draw s at |
1 |