Dependency on IV hydration > 1 day per week within the screening period
SCREENING/PRE-SCREENING REGISTRATION:
Patients who have had a transfusion within 7 days of screening are NOT eligible for participation
Patients who are candidates for enrollment for the phase I or surgical studies must sign a screening consent and provide pre-trial tumor material for Rb1 testing unless testing is not needed due to diagnosis or the availability of prior Rb1 IHC results; the screening consent is to be obtained according to institutional guidelines
Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection in the 30 days before screening.
Positive serology for HTLV 1 or 2. Re-screening for infection disease markers is not required at baseline (prior to lymphodepleting chemotherapy)
No documented myelofibrosis at screening marrow biopsy
Inclusion Criteria:\n\n        Subjects must meet the following criteria to be included:\n\n          -  Willing and able to read, understand and sign an informed consent form\n\n          -  Confirmed diagnosis by enrolling physician of WAIHA\n\n          -  Must use medically acceptable contraception\n\n        Exclusion Criteria:\n\n        Subjects meeting any of the following criteria are to be excluded:\n\n          -  Subject unable or unwilling to comply with the protocol\n\n          -  Active non-hematologic malignancy or history of non-hematologic malignancy in the 3\n             years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in\n             situ)\n\n          -  Positive for HIV or hepatitis C antibody\n\n          -  Positive for hepatitis B surface antigen\n\n          -  Any exposure to an investigational drug or device within the 30 days prior to\n             screening\n\n          -  IVIG treatment within 60 days of screening\n\n          -  Plasmapheresis or immunoadsorption within 60 days of screening\n\n          -  Subject has any current medical condition that, in the opinion of the Investigator,\n             may compromise their safety or compliance, preclude successful conduct of the study,\n             or interfere with interpretation of the results
ELIGIBILITY FOR SCREENING: EBV positive tumor (can be pending)
Received bupivacaine or any other local anesthetic within 7 days of screening.
Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than 2 months prior to the screening.
Lactic acid levels > 2 mmol/L and/or serum pH < 7.35 at screening.
Experienced at least 1 VOC within the preceding 12 months prior to Screening, as determined by medical history.
If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the drug for at least 6 months prior to Screening
Ongoing hospitalization prior to Screening
Immunomodulatory therapy: ? 28 days prior to screening.
Females who are breastfeeding or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 h before the first dose of study drug.
Positive screening EBV antibody titer on screening test
Syncopal episode within 12 months of screening
Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator
CRITERIA FOR SCREENING
No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened one time, >= 2 months after therapy
Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment
PRE-SCREENING: Mesothelin positive
PRE-SCREENING: No history of keratitis or corneal disease
PRE-SCREENING: No prior treatment with anetumab ravtansine (or any other mesothelin-based therapy)
Grade ?2 hypotension at screening
If currently receiving erythroid stimulating agents (ESA) with plans to continue during study, less than 2 months duration of therapy with ESA prior to screening or dose escalation performed within 2 months of screening or addition of granulocyte colony stimulating factor (GCSF) to ESA within 2 months of screening
Lactate levels > 2 mmol/L and or and serum pH < 7.35 at screening
Patients who fail MRI screening
Diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera (post-PV) myelofibrosis (MF) or post-essential thrombocythemia (post-ET) MF based on the World Health Organization (WHO) criteria or the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria, which must be confirmed by bone marrow (BM) aspirate and/or biopsy within 6 weeks prior to screening; measurement of janus kinase 2 (JAK2) V617F allele burden in BM samples, if not done within 6 months prior to screening, must be provided with the screening BM biopsy/aspirate report (patients are eligible regardless of JAK2 mutation status)
Investigational therapy within 2 weeks of screening
Had alemtuzumab therapy within 12-weeks prior to screening.
Patients will not be seen for screening appointments or enrolled on the protocol if they have been hospitalized within the 7 days prior to the screening appointment or the date of protocol enrollment
Patients must have a positive screening Epstein-Barr virus (EBV) antibody titer on screening test as this is required to protect against EBV infection during the time of lymphodepletion
All participants are screened before MR examination using a MRI safety screening questionnaire as part of Columbia University Medical Center/New York-Presbyterian (CUMC/NYP) MRI safety policy; any patient who would normally be excluded by this screening process would also be excluded from this study
Syncopal episode within 12 months of screening
Psychiatric hospitalization within 1 year of screening date
Had eculizumab therapy within three months prior to screening
Syncopal episode within 12 months of screening
Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
Hemoglobin >= 8 g/L, at screening
SCREENING:
Positive Hepatitis C test result at screening or within 3 months prior to first dose of study treatment.
Clinical diagnosis of TDT with ? 8 documented RBC transfusion events per year on an annualized basis in the 2-years prior to screening
Pregnant women must not take part in this trial and will be considered as screening failures.
Clinically stable in NYHA class 2 or 3 for the 3 months preceding screening
Orthopnoea of sufficient severity to preclude supine scanning as determined at screening
Orthopnoea of sufficient severity to preclude supine scanning as determined at Screening
Screening CLEC12A level ? 20%;
Normal electrocardiogram at screening
Treatment with systemic cancer therapy within 21 days before screening.
Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
The subject has an active cancer being treated with chemotherapy at the time of screening
Investigational therapy within 4 weeks of Screening.
PSTAT3 SCREENING: Availability of archival tissue specimen suitable for pStat3 testing; either paraffin-embedded or fresh frozen sample is allowed for screening; testing of either primary or recurrent specimen is allowed for screening
Participants must be hepatitis C negative =< 6 months prior to screening
Patients must have a positive screening Epstein Barr virus (EBV) antibody titre on screening test as this is required to protect against EBV infection during the time of lymphodepletion
Patients must have a positive screening Epstein-Barr virus (EBV) antibody titre on screening test
All patients who have received prior chemotherapy for histologically proven advanced non-small cell lung cancer, and whose tumors display the appropriate phenotype, i.e. high ISG15 (ISG15H), are eligible; results of tumor screening will be sent in writing from Lovelace Respiratory Research Institute within 14 days of submitting tumor specimens for screening; screening may occur prior to failure of frontline, second, or third line regimen\r\n* Note: A separate informed consent document will be available for patients to undergo screening for ISG15H status
Participants with known or suspected COPD must have a FEV1 test during Screening
Is suspected to have certain other protocol-defined diseases based on imaging at screening period
Hospitalization within 2 weeks prior to screening
Bone marrow biopsy at screening (unless it was performed within 3 months prior to screening)
Investigational therapy within 4 weeks of Screening.
Hb < 10 g/dL at screening OR have received at least one transfusion within 12 months prior to screening
Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
SCREENING
SCREENING
Have circulating HAMA noted on initial screening
Patient has positive urine cytology for malignancy at Screening.
Acute thrombosis within 3 months of screening
Screening 99mTc-MDP bone scintigraphy showing a superscan;
At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Participants with known or suspected COPD must have a FEV1 test during screening
Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
Vasectomy or surgical castration at least 6 months prior to Screening.
Moderate to severe cGVHD (in accordance with 2014 cGVHD NIH Consensus Criteria [Jagasia, 2015; Appendix 9]) at screening with involvement of at least one of the following organs at the screening and baseline visits: skin, mouth, eyes, gastrointestinal (GI) tract, liver, lungs, and joint and fascia.
Subjects may not have had a transfusion within 7 days of screening assessment
laboratory criteria at screening:
WBC > 11.0 × 10^9/L at screening.
Ferritin> 1000 mcg/L at screening
Evidence of TLS at screening
Presence of DVT on pre-operative screening ultrasound study
The donor has donated plasma within 7 days before screening or has donated blood within 56 days before screening.
Recent chemotherapy within 3 weeks of screening
No increase in steroid dose during the week prior to screening brain MRI
Subject has symptomatic or untreated central nervous system (CNS) metastases; any type of active seizure disorder; febrile neutropenia; ? Grade 2 peripheral neuropathy; peritoneal or pleural effusions requiring a tap more frequently than every 14 days; QT interval corrected (QTc) prolongation or a prior history of serious arrhythmias or significant abnormalities on screening ECG; previously experienced a severe reaction to a liposomal product or a taxane; received IV treatment for bacterial/fungal infection within 7 days of screening.
Prior TACE < 6 months prior to screening phase in case of patients progressing from an intermediate to an advanced stage due to occurrence of PVT
Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
A positive pre-study drug/alcohol screening (testing at time of screening is not required).
Certain scores on an anxiety and depression mood questionnaire given at screening
Administration of an investigational therapeutic within 30 days of screening
Major trauma within 36 hours of screening
Availability of subject to be observed for up to 18 months post-screening evaluation
Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
Documented, confirmed OIC defined as less than 3 laxations per week over a 1-week OIC confirmation period at any time during screening and prior to initial treatment period day 1
Does not have health insurance at screening
Have evidence of at least mild clinical depression on a standardized screening questionnaire
Patient treated with antifibrinolytic agents (including EACA) within 14 days prior to screening
Intelligence quotient (IQ) below 70 based on baseline/screening assessment
No documented bacteremia at time of initial screening
Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
Patient already on NIPPV at the time of screening
Score of 34 or greater (>= 34) on the Prolonged Grief (PG)-13 at screening
Subjects who have unknown transfusion history for at least the 12 weeks prior to screening
Completion of successful fMRI safety screening
Is currently in a partnered relationship that could involve sexual activity (as determined by eligibility screening script)
ECOG performance status of 0 or 1 at screening and within 72 hours prior to first dose if first dose occurs more than 72 hours post-screening
Patient has a Karnofsky performance status (KPS) ? 70 at Screening, and within 72 hours prior to date of first dose if first dose occurs more than 72 hours after screening (Part 1B only)
Serum albumin < 3 g/dL at screening visit and within 72 hours prior to first dose if first dose occurs more than 72 hours post screening
Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= 5)
For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND for whom a prior mammogram interpretation is not available, breast density will be determined by the radiologist’s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic 2D portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM
Women who report no history of Pap screening within the last four years
Asymptomatic women presenting to the imaging center for a screening mammogram
Women scheduled for screening WBUS and a screening full field digital mammography (FFDM) on the same day or within the following 30 days of each other
Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have a expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
Individuals that fall within the age range for CRC screening surveillance from AHP
Are eligible for CRC screening surveillance from AHP
Are not eligible for CRC screening surveillance from AHP
Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
Women who have a screening digital mammogram on the day of CESM or within 365 days prior
Women with “mosaic mammographic screening views”, i.e., whose larger breast size precludes being imaged within a single mammographic screening view
Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed.
Received a negative mammography screening result in the previous four weeks
Psychiatric hospitalization within 1 year of screening date
Underwent screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months
Psychiatric hospitalization within 1 year of screening date
Inflammatory eye disease requiring steroid treatment within 28 days of screening
Smoking history >= 20 pack/years; subjects must be included in an ongoing annual screening with low dose CT scan or must have two consecutive CT outside the context of a screening program confirming subsolid nodules
Up to date with CRC screening guidelines.
Successful completion of MRI screening form
The subject is clinically node negative (cN0) at the time of screening
the use of the copper-releasing intrauterine device (to have been in place for at least 2 months prior to screening)
Patient should pass MRI screening questionnaire
FOBT or FIT screening completed within the last year
Half of the participants will be overdue for CRC screening and the remaining half will be current on their screening, as defined by national published guidelines
Positive Coombs tests at screening.
Initiation of new photosensitizing drugs within 30 days of Screening.