Hepatitis B or C serologies consistent with past or current infections
Known active infections
No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)
Patients with clinically significant active infections
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
Use of antibiotics to treat chronic infections within 28 days prior to first dose
Active systemic infections requiring antibiotics
Active clinically serious infections or other serious uncontrolled medical conditions
Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
Active bacterial infections.
Uncontrolled infections
No active serious infections or other conditions precluding chemotherapy
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
Active infections requiring antibiotics, physician monitoring or recurrent fevers >100.4?F (38.0?C) associated with a clinical diagnosis of active infection
Active or uncontrolled infections
Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
Active viral or bacterial infections: this includes any infections that are being actively treated even if the signs and symptoms appear to have resolved. Courses of antibiotics or anti-viral treatment should be completed before the patient is enrolled
Active hepatitis viral infections
Active serious infections not controlled by antibiotics
Patients with active infection requiring antibiotics are not eligible (with the exception of uncomplicated UTI and uncomplicated respiratory tract infections)
Active (acute or chronic) or uncontrolled severe infections
History of ocular events related to keratitis or corneal disorders, or any current ongoing active ocular infections.
Patients who have an active infection requiring systemic therapy are not eligible, except for uncomplicated urinary tract infections
Uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Must have no ongoing active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
Active or uncontrolled infections
Severe infections within 4 weeks prior to Cycle 1, Day 1
Any evidence of serious active infections; any infections being treated must complete antibiotic therapy at least 7 days before planned first dose.
Have active (acute or chronic) or uncontrolled severe infections
Serious illnesses, e.g., serious infections requiring antibiotics
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses
Concurrent opportunistic infections
Concurrent opportunistic infections
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
Concurrent opportunistic infections
Chronic infections (e.g., hepatitis B or C, tuberculosis)
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Concurrent opportunistic infections
Repeated infections requiring oral or i.v. antibiotics
Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.
Patient with active, uncontrolled infections (patients must be afebrile for > 48 hours off antibiotics).
Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
Active or fungal infections requiring systemic treatment within 7 days prior to screening
Uncontrolled active systemic infections
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
Severe infections within 4 weeks prior to enrollment;
Concurrent opportunistic infections
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active major medical illnesses of the cardiovascular, respiratory or immune system
Patients who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must have been adequately treated for at least 2 weeks before study entry; subjects with bacteremia must have documented negative blood cultures prior to study entry
Active infections
Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system. Principal investigator (PI) or his/her designee shall make the final determination regarding appropriateness of enrollment.
Active or uncontrolled infections
Patients with active infections. The principal investigator (PI) is the final arbiter of the eligibility;
Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active or uncompensated major medical illnesses
Patients with any active and uncontrolled infections (such as bacterial, fungal, and new or reactivated viral infections)
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 14 days prior to randomization
Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Infections such as pneumonia or wound infections that would preclude protocol therapy.
Uncontrolled infections.
Concurrent opportunistic infections
Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active or uncompensated major medical illnesses
Acute or chronic infections requiring systemic therapy, including, among others:
Systemic rheumatic or autoimmune diseases or acute or chronic infections
Patients with active systemic infections requiring intravenous antibiotics within 1 week prior to enrollment
No uncontrolled infections;
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
Concurrent opportunistic infections
No uncontrolled infections;
Other active infections aside from hepatitis
Presence of any serious illnesses, serious medical conditions, serious medical history, active bacterial or viral infections including hepatitis B or C, or known to be HIV positive.
FOR ALL PHASES (Ib AND II): Uncontrolled infection; active, clinically serious infections (> CTCAE grade 2)
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
No active infections
Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility
Severe infections ? 4 weeks prior to enrolment in the study as well as active, uncontrolled bacterial, viral or fungal infections requiring systemic treatment.
Active infections within 48 hours of study entry
Active uncontrolled acute infections
Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when the intravenous antibiotics have been administered for less than 72 hours); active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system; history of myocardial infarction; history of ventricular tachycardia or ventricular fibrillation; active cardiac arrhythmias (active atrial fibrillation is not allowed, but resolved atrial fibrillation is allowed); active obstructive or restrictive pulmonary disease; or active autoimmune diseases such as rheumatoid arthritis
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
Evidence of active infections =< 7 days prior to initiation of study drug therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry)
Active uncontrolled bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy
Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible
Known active infections
CELL PROCUREMENT: Patients who are on treatment for other active uncontrolled infections (not referenced above) with resolution of signs/symptoms are not excluded; non-influenza, non-respiratory syncytial virus (RSV), isolated upper respiratory infections are not excluded; other active uncontrolled infections will be excluded
LYMPHODEPLETION: Patients who are on treatment for other active uncontrolled infections (not referenced above) with resolution of signs/symptoms are not excluded; non-influenza, non-RSV, isolated upper respiratory infections are not excluded; other active uncontrolled infections will be excluded
Significant acute or chronic infections requiring systemic therapy
Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility
Active, clinically serious infections or other serious uncontrolled medical conditions
Active clinically serious infections requiring antibiotics, antiviral or antifungal agents; participants must be off these agents for at least 28 days prior to the first dose of the study drug
Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptable
Active uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Uncontrolled infections
Concurrent opportunistic infections
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
Concurrent opportunistic infections
Active or uncontrolled infections
Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
Active or uncontrolled infections
Patient with known active herpes simplex virus infections (prior uncomplicated oral herpes simplex virus [HSV] lesions are not an exclusion), prior complications from HSV infections such as encephalitis, or who require systemic antiviral therapy at the time of study enrollment should be excluded
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Not have active, uncontrolled infections
Active, uncontrolled infections
No active infections requiring systemic antibiotics
Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias (active atrial fibrillation is not allowed, resolved atrial fibrillation not requiring current treatment is allowed [anticoagulants count as current treatment]), active obstructive or restrictive pulmonary disease, active autoimmune diseases such as rheumatoid arthritis
Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded
Active clinically serious infections (> CTCAE grade 2)
Concurrent opportunistic infections
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Active HBV or HCV infections requiring therapy.
Known active infections or oral temperature > 38.2 Celsius (C) fewer than 72 hours prior to receiving study treatment or systemic infection requiring chronic maintenance or suppressive therapy
Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry
PHASE I: Patients should be free of active infection requiring antibiotic therapy (except for uncomplicated urinary tract infections)
PHASE II: Patients should be free of active infection requiring antibiotic therapy (except for uncomplicated urinary tract infections)
Presence of an infection including ulcerations and fungal infections in the breast to be studied
Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Active infections requiring therapy, including HIV, hepatitis
Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment
Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment
Active known clinically serious infections
Patients with other uncontrolled infections (except HIV/AIDS); for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Evidence of active infections
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Evidence of active infections
Patients with uncontrolled active infections (fever >= 38 degrees Celsius [C], septic shock)
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Serious concomitant systemic disorders (including active infections or chronic infection requiring suppressive antibiotics) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Patients with multiple viral infections including AdV are eligible if their AdV infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
Patients with other uncontrolled/progressing infections defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
Uncontrolled infections
Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection; patients with ongoing viral infections are excluded
Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Concurrent opportunistic infections
Patients with active, uncontrolled infections
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Concurrent opportunistic infections
Patients with multiple CMV, EBV, adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy; patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll
Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment\r\n* Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved
Patients with systemic infections and/or organ dysfunction mandating a reduced intensity conditioning regimen are also excluded
Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
Concurrent opportunistic infections
Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile I)
Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile II)
Have active, acute, or chronic clinically significant infections.
Uncontrolled infections; principal investigator (PI) is the final arbiter of this criterion
Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies
Active Mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter and Leishmania infections.
Patients who have uncontrolled systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems
Active and uncontrolled infections
Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile I)
Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile II)
Patients with untreated or uncontrolled infections
No uncontrolled infections as determined by the investigator
Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved
Active systemic infections (requiring anti-infective treatment), coagulation disorders, or any other active or uncompensated major medical illnesses
Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
Recent or ongoing serious infections within 2 weeks
Patients with uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Active serious infections not controlled by antibiotics
Evidence of active infections
Patients with serious uncontrolled infections will not be eligible
Patients with serious uncontrolled infections at the time of planned transplant will be excluded
Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress test and/or abnormal PFT; PI or designee shall make the final determination regarding appropriateness of enrollment (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Active serious infections not controlled by antibiotics
Known infections:
Uncontrolled infections not responding to antimicrobial therapy or requiring intensive critical care or vasopressors
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator, including active autoimmune disease requiring treatment within the past 30 days
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
Has uncontrolled active infection of any kind. (Patients with infections controlled by active antibiotic treatment are eligible).
Patients with active chronic or current infections requiring oral or intravenous antibiotics are NOT eligible for enrollment to the study until resolution of the infection and completion of therapeutic antibiotics
Active and uncontrolled systemic infections.
Histry of significant chronic or recurrent infections requiring treatment
Concurrent serious infections (i.e., requiring an intravenous antibiotic)
Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival
Acute or chronic infections requiring systemic therapy, including, among others:
Active clinically serious infections (? CTCAE v4.03 Grade 2).
Active infections
Concurrent vaginal, vulvar, anal lesions or symptomatic infections
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred.
Infections:\r\n* Known active current or history of recurrent bacterial, viral, fungal, parasitic, mycobacterial or other opportunistic infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds)\r\n* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to enrollment\r\n* History of tuberculosis or positive PPD without anti-mycobacterial therapy and/or active tuberculosis (TB) requiring treatment within the previous 3 years; subjects treated for tuberculosis with no recurrence in 3 years are permitted\r\n* Human immunodeficiency virus (HIV) positive, hepatitis B surface antigen or core antibody positive, hepatitis C infections (current or past), active Epstein-Barr virus infection\r\n* History of 2 or more episodes of cellulitis within the past 12 months\r\n* History of recurrent herpes simplex infections requiring suppressive antiviral therapy\r\n* History of invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii\r\n* History of recurring or chronic infection
Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry
Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =< 12 weeks prior to registration
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma
DONOR: Current serious systemic illness including uncontrolled infections
Current uncontrolled infections.
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Patients who have an uncontrolled infection are not eligible; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Active clinically serious infections or other serious uncontrolled medical conditions
Active systemic infections (defined as infections causing fevers or requiring anti-microbial treatment), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, active cardiac arrhythmias, active obstructive or restrictive pulmonary disease
Active infections or oral temperature > 38.2º Celsius (C) within 48 hours of study entry
Uncontrolled infections
Active bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Active (acute or chronic) or uncontrolled severe infections.
Serious, active infections requiring treatment with IV antibiotics
Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded
Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illness of the cardiovascular, respiratory or immune system, which in the opinion of the PI or treating co-investigator is not acceptable risk for ACT, are excluded
Subjects must have recovered from major infections and/or surgical procedures and, in\n             the opinion of the investigator, not have a significant active concurrent medical\n             illness precluding protocol treatment.
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Active (acute or chronic) or uncontrolled severe infections
Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible
Patients with serious uncontrolled infections at the time of transplant will be excluded
They have active infections such as hepatitis or fungal infections.
Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Significant acute or chronic infections
Active or uncontrolled infections
Poor medical risk because of systemic diseases (e.g. active uncontrolled infections) in addition to the qualifying disease under study.
Active, unresolved infections
History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
Acute infections requiring parenteral therapy
Severe infections at the time of randomization
required parenteral antimicrobial therapy for active, intercurrent infections
Active uncontrolled infections
Known systemic infections including, but not limited to hepatitis B or C, or HIV
All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Active systemic infections requiring intravenous antibiotics
Patients with known systemic infections requiring antibiotics or chronic maintenance/suppressive therapy
Active clinically serious infections (> grade 2)
Patients with systemic infections requiring active therapy within 72 hours of lymphodepletion
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
Uncontrolled infection within one week of the first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Patients with active systemic infections requiring antibiotics or active hepatitis A, B, or C.
Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease
Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
No active infections requiring systemic therapy
No active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
History of, or presently active or chronic viral infections (i.e. zoster or hepatitis)
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Active clinically serious infections > CTCAE Grade 2
Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
Subjects with signs or symptoms of other major diseases including, but not limited to: end organ failure, major chronic illnesses other than cancer, coagulation disorders, hemolytic conditions (eg, sickle cell disease ) or active infections that, in the opinion of the investigator, make it undesirable for the subject to participate in the study.
Severe infections within 4 weeks prior to randomization
Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics
Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ?14 days before the first dose of study drug.
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Severe infections within 4 weeks prior to Cycle 1, Day 1
Infections such as pneumonia or wound infections that would preclude protocol therapy
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Patients must have recovered from any major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active medical illness precluding protocol treatment or survival
Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Active clinically serious infections
Infections or intercurrent illness requiring active therapy
Active (acute or chronic) or uncontrolled severe infections hepatitis
Severe infections within 4 weeks prior to Cycle 1 Day 1
Other active serious illnesses (e.g., serious infections requiring antibiotics).
Patients who have active infections requiring therapy.
Serious concurrent medical illnesses (including uncontrolled major cardiac, pulmonary, Child-Pugh C liver or psychiatric diseases) or active major infections (including human immunodeficiency virus [HIV], hepatitis A-C)
Subjects with clinically serious infections requiring ongoing antibiotic therapy
Recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of study drug
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have significant active concurrent medical illnesses precluding study treatment
Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.
Subjects who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry
Any evidence of serious active infections
Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
Severe infections necessitating use of antibiotics / antivirals during the screening period
Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Uncontrolled infections
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
Patients must not have any active infections
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent
Serious, active infections requiring treatment with intravenous (IV) antibiotics
Concurrent opportunistic infections
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Patients with severe systemic infections
Uncontrolled systemic disease like active infections
Active serious infections not controlled by antibiotics
Active hepatitis or other active infections
Patients with active clinical infections
Active infections not responding to therapy; all efforts should be made to clear the infection prior to enrollment
Known active infections
Active systemic infections, coagulation disorders or other major medical illnesses
Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
Significant acute or chronic infections, including:
Patients with active infections requiring systemic treatment.
c. Active or failed to control serious infections (CTCAE version 4.03 > grade 2 infections)
Known active infections
Active systemic infections requiring intravenous antibiotics
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Active infections requiring systemic antibiotics.
Active infections requiring systemic antibiotics.
certain heart problems, active or chronic infections, serious significant diseases, AIHA requiring treatment, other current cancer or within last 5 years
Patients with acute infections (viral, bacterial or fungal infections requiring therapy)
Active clinically serious infections (i.e. patients currently taking antibiotics)( Grade 2 NCI-CTC Version 3.0)
Known HIV and/or Hepatitis B or C infections
DONOR: Current serious systemic illness including uncontrolled infections
Patients must be free of active infections requiring antibiotics, with the exception of uncomplicated urinary tract infections (UTIs)
Current infections requiring antibiotic therapy.
Any evidence of serious active infections.
DONOR: No active or chronic infections
Clinically significant uncontrolled illness or active infections
Active uncontrolled serious infection or sepsis at study enrollment; patients receiving antibiotics for infections that are under control may be included in the study
Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
Chronic or current infectious disease requiring systemic antibiotics, antifungal (excluding antifungals given for nail-beds infections), or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
Uncontrolled life-threatening infections
Active or uncontrolled infections
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma
Patients requiring intravenous (IV) antiviral or IV antibiotic treatment for ongoing infections
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy
Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections
Active and uncontrolled infections, including hepatitis B or C
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Patients must not have active uncontrolled infections, other medical or psychological/social conditions that might increase the likelihood of patient adverse effects or poor outcomes
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Active infection requiring systemic treatment or any uncontrolled infections =< 14 days prior to enrollment
8. Any evidence of serious active infections.
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
Active infections prior to receiving study treatment or systemic infection requiring chronic maintenance or suppressive therapy
Patients with active infections, including HIV, will be excluded
Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Severe infections within 28 days prior to the first dose of study treatment
Severe intercurrent infections
Concurrent serious infections requiring parenteral antibiotic therapy.
Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
Does not have an uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Patients with other uncontrolled/progressing infections defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Any evidence of serious active infections
Active or chronic recurrent systemic infections that require continuous antimicrobial therapy during the Kevetrin study period
Active infections requiring antibiotics
Infections
Active or incompletely treated infections that could involve the device implant site.
Patients with systemic infections requiring antibiotics or chronic maintenance/suppressive therapy
Patients with uncontrolled concurrent illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever > 38.5°C on the day of scheduled dosing
Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved
Chronic or current active infections requiring systemic antibiotics, antifungals or antiviral therapy
Known active infection (except fungal nail infections).
Patients with multiple CMV, EBV or adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above; patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll
Uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment
Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent
Active infections, including opportunistic infections
Severe systemic infections, current or within the two weeks prior to initiation of AEB071.
Active (acute or chronic) or uncontrolled severe infections
Severe systemic diseases or active uncontrolled infections
Have active, acute, or chronic clinically significant infections or bleeding.
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Severe infections within 4 weeks prior to Cycle 1, Day 1
Recent infections not meeting the criteria for severe infections within 2 weeks prior to Cycle 1, Day 1
Participants who have active, uncontrolled infections.
Patients with important infections requiring antibiotics are INELIGIBLE, but patients who acquire minor infections while on the study may remain on the study
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Opportunistic infections
Patients with active infections; the principal investigator (PI) is the final arbiter of the eligibility
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Known active infections requiring IV antibiotic, antiviral, or antifungal therapy.
Acute infections (viral, bacterial or fungal infections requiring therapy).
Patients with active infections, including HIV, will be excluded, due to unknown effects DAC/THU on systemic immunity
Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Active systemic infections requiring intravenous antibiotics
Concurrent opportunistic infections
Active systemic infections (for e.g.: requiring anti-infective treatment), coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
Concurrent opportunistic infections
Patients with active systemic infections requiring antibiotics or chronic maintenance/suppressive therapy; once the infection in question has resolved and patient is off antimicrobial treatment, patients may participate
Uncontrolled (not being treated) infections at the time of cytoreduction
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Patients with opportunistic viral infections other than CMV
Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
Local skin infections at or near the acustimulation site
Uncontrolled infections that are not responsive to antimicrobial therapy
Local skin infections at or near the acupuncture sites or are under treatment for active systemic infection
Severe infections within 4 weeks prior to Day 1
Active clinically serious infections of > Grade 2
Active serious infections uncontrolled by antibiotics
Patients who have uncontrolled systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems.
Patients with any active hepatitis infections.
Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 2 weeks before Segment B enrollment
Local skin infections at or near the acupuncture sites or active systemic infection
Patients must have no evidence of active infections at the time of transplantation
There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy
Patient with active infections
Active and uncontrolled infections
Treatment may be given to eligible patients with a single or multiple infections; patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll
Patients with other uncontrolled infections; for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
Patients with uncontrolled infections
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
Active uncontrolled bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
Active infections requiring systemic therapy
Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.
Evidence of severe pulmonary infections, as judged by the investigator
Subject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.
Patients with ongoing symptomatic dental infections
active infections of the oral cavity
Active infection (except mild upper respiratory infections)
Uncontrolled intercurrent illness including, but not limited to active infections
Patients with clinically significant active infections
Patients with known active treatment for hepatitis B and C infections
Active serious infections not controlled by antibiotics
Patients with active urinary tract infections
Patients should not have active infections or concurrent neoplastic disease except for skin cancer
Documented acute prostatitis or urinary tract infections
Active acute infection (i.e. currently treated with antibiotics); patients with chronic infections such as hepatitis B or C, mycobacterium avium or similar infections will be eligible provided they meet all other eligibility criteria
Patients with invasive fungal infections
Patients with known active treatment for hepatitis B and C infections
Clinically active hepatitis A, B, or C infections
Active infections of oral cavity
Patients with active treatment for active hepatitis B and C infections
Patients with active infections.
Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization
Active, uncontrolled infections within 7 days of study entry requiring systemic therapy.