Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery
Appropriate antibiotics, blood products, anti-emetics, fluids, electrolytes and general supportive care are to be used as necessary
Acceptable blood work
Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib
Refusal to potentially receive blood products and/or have a hypersensitivity to blood products
Blood transfusion within 4 weeks prior to screening
Non-leukocyte leukocyte-depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Abnormal blood results
Received transfusion of blood products or administration of colony stimulating factors within 4 weeks prior to the first dose of treatment.
Difficulty providing blood samples.
Patients who are receiving licensed cord blood products (only)
Patients who are receiving unlicensed cord blood products from other banks (only)
Patients who are receiving cord blood products that will be \manipulated\ post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
To be performed within 14 days prior to day 1 of protocol therapy: platelets >= 100,000/mm^3\r\n* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
To be performed within 14 days prior to day 1 of protocol therapy: hemoglobin (HgB) >= 9.0 g/dL\r\n* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Received blood products within 30 days to first dosing
Patients with known sensitivities to albumin, blood, or blood products
Non-leukocyte depleted whole blood transfusion within 120 days of the date of patient's start on the study
Blood transfusion within 30 days of consent
Willing to donate blood for research at 4 time points
Willing to donate blood for research at 4 time points
Blood transfusion (including blood products) within 1 week of screening.
Blood transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility
Patients who decline possible transfusion of blood products will be excluded
Patients must be willing to receive transfusions of blood products
Blood transfusion within 5 days of the blood draw being used to confirm eligibility
Agreement not to donate blood or blood products during the study and for 7 months after discontinuation of vismodegib
ELIGIBILITY CRITERIA AT THE TIME OF APHERESIS: Patients must NOT have an active severe infection defined as:\r\n* A positive blood culture 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
Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
Relapsed/refractory MCL: Patients must be willing to receive transfusions of blood products
Appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary
DONOR: Has not donated blood products to recipient
History of at least one documented blood transfusion within 6 months of enrollment
Donation of blood or blood products in excess of 500 mL within 84 days of screening
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors within 4 weeks prior to study Day 1.
Acceptable blood sugar control
Agreement to provide blood samples for pharmacodynamic studies utilizing Peripheral Blood Mononuclear Cells (PMBCs) as outlined in the protocol
Difficulty providing blood samples.
A recognized single pathogen cultured from 1 or more blood cultures; OR
Troponin blood level within normal limits.
Unwillingness to receive infusion of blood products.
Patients must be willing to receive transfusions of blood products.
The subject must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 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 results. Both samples should 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.
Unwillingness to receive infusion of blood products according to the protocol.
Acceptable blood sugar control:
Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab.
refrain from breastfeeding and donating blood or oocytes
blood transfusion(s) prior to 1990,
Subjects who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to randomization
Subject is unwilling to allow transfusion of blood or blood products.
Has not donated blood products to patient
Within 72 hour (h) of initiating study treatment: Hemoglobin (Hgb) >= 9.0 g/dL; Note: transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment
Within 72 h of initiating study treatment: Platelets >= 100,000/mm^3; Note: transfusions of blood and blood products as well as growth factor support are prohibited within 14 days prior to the first dose of study treatment
Consent to potential need for transfusion of blood products
Patients must be willing to receive transfusions of blood products
Anticipated blood donation within the next 90 days
Transfusion of blood products are not allowed to normalize blood parameters within 4 weeks of the first radium treatment
Have a cancer of the blood
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the pharmacogenetic sample collection.
Patients with any history of hyperglycemia (elevated blood glucose level on blood chemistries) should be considered for initiation of Metformin treatment (500mg, PO, twice daily) prior to starting BKM120
Blood transfusion within 5 days of the blood draw being used to confirm eligibility
Patients must be willing to receive transfusions of blood products
Absence of gross blood in stool; red blood on toilet paper only acceptable.
Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
All patients should agree not to donate blood products for 12 months after stopping sonidegib
Blood or albumin transfusion within 5 days of the blood draw being used to confirm eligibility
Hematopoietic growth factors, transfusions of blood or blood products within 1 week
Hematopoietic growth factors, transfusions of blood or blood products within 1 week
DONOR: meet other blood bank criteria for blood product donation (as determined by NBAH Blood Center screening history and laboratory studies)
Abnormal blood test results
Patients must be willing to receive transfusions of blood products
Agreement not to donate blood or blood products during the study and for 7 months after discontinuation of vismodegib
Acceptable blood test results.
History of anaphylactic reaction(s) to blood or blood components.
Refusal to receive allogenic transfusion of blood-derived products.
Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
blood transfusion or hemopoietic factor therapy
Adequate availability of sickle trait negative, leukoreduced, Blood type (ABO) blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement RBC products.
Subjects who refuse blood products.
History of expectoration of blood within 1 month prior to study start or blood clotting problems.
Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Blood or albumin transfusion within 5 days prior to the blood draw being used to confirm eligibility
Blood transfusion within 5 days prior to blood draw being used to confirm eligibility
DONOR: Has not donated blood products to patient
Refrain from donating blood or semen as defined by protocol
Patients must be willing to receive transfusions of blood products
Research blood 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
Patients must be willing to submit blood specimens
Previous treatment with pathogen-reduced blood products
History of blood clot;
Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood
DONOR: has not donated blood products to patient
Pregnancy as assessed on baseline blood hCG level
Women with blood pressures above 180/100 or below 80/50
Estimated blood loss (EBL) > 1 liter
Be willing and able to travel to UCSF for pre- and post-study blood collection
Not able to travel to UCSF for the pre- and post-study blood collection
Difficulty providing blood samples.
Patients with hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products
Thalassemia major or sickle cell disease requiring blood transfusion
Unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose
Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
Previous blood transfusion (7 days prior to genetic testing)
Must be willing to have about 40 cc of blood (approximately 8 tablespoons) drawn at each aspiration visit
Willingness to provide mandatory blood specimens
Transfusion of blood products or intravenous immune globulin within 3 months of study entry
Negative fecal occult blood test
Must be willing to have about 30 ml of blood drawn at 0, 6 and 12 months and about 5-10 ml of blood at 3 and 9 months
Willing to donate 90 mL of blood and endoscopic mucosal biopsies for research
Eligible for donations of human blood and blood components according to local requirements and regulations
Must be willing to have about 30 ml of blood (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
Agreement not to donate blood or blood products during the study and for 7 months after the last dose
Inability to place an IV catheter or draw blood for any reason
Patients must be able to lie flat to obtain the functional scans or have blood access for blood samples
Patients with known sensitivities to albumin, blood, or blood products
Peripheral Blood Samples:
Blood 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
Willing to allow blood collections
Abnormal blood results
Patient agrees to the collection and testing of their blood and is willing and able\n to provide approximately 40mL blood draw(s) at:
Refusal to accept allogeneic or autologous blood transfusion
Unable to accept blood product transfusions
Must be willing and able to accept at least three leukapheresis procedures
Unwillingness to accept the treatment;
Must be willing and able to accept at least three leukapheresis procedures
Willing to consent and accept randomization
Patients must be willing to accept blood product transfusions
Must be willing and able to accept two leukapheresis procedures
Must be willing and able to accept the leukapheresis procedure
Must be willing and able to accept at least two leukapheresis procedures
Must be willing and able to accept at least two tumor biopsies
Must be willing and able to accept two leukapheresis procedures
Must be willing and able to accept at least two leukapheresis procedures
Must be willing and able to accept at least two tumor biopsies
Subjects must be willing to accept/continue transfusions to treat low hemoglobin levels
Unwilling to accept blood product transfusions
Willingness to accept randomization to each of the three arms
Must have, or accept to have, an acceptable central catheter for infusion of melflufen