Patients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXOpportunistic infection within the last 3 monthsXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPresence of an active uncontrolled infection.Xx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection that requires systemic treatmentXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXSTEP I: Patients must not have active, uncontrolled infectionXx_NEWLINE_xXPatients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocolXx_NEWLINE_xXPatients must not have documented evidence of acute hepatitis or have an active or uncontrolled infectionXx_NEWLINE_xXPatients with septicemia or severe infectionXx_NEWLINE_xXPatient must not have an active uncontrolled infectionXx_NEWLINE_xXPatients with hepatitis C virus (HCV) infection are eligible provided they meet the other eligibility criteria and:\r\n* They have previously undergone curative therapy and have no evidence of active HCV infection\r\n* They have no evidence of liver damage owing to prior HCV infectionXx_NEWLINE_xXPatients with septicemia or severe infectionXx_NEWLINE_xXActive, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilationXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients with uncontrolled infectionXx_NEWLINE_xXAny active acute or chronic or uncontrolled infectionXx_NEWLINE_xXPatients with active, uncontrolled infectionXx_NEWLINE_xXSubject has an active infectionXx_NEWLINE_xXActive HBV or HCV infection.Xx_NEWLINE_xXUnstable systemic disease or active uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infection;Xx_NEWLINE_xXPatients with a clinically apparent active infection will not be eligible (please note, an isolated elevation in the white blood cell count, by itself, does not constitute evidence of an infection)Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients with an active infection or serious intercurrent medical illnessXx_NEWLINE_xXPatients with uncontrolled infectionXx_NEWLINE_xXNo evidence of intercurrent infectionXx_NEWLINE_xXHas an active infection requiring systemic therapy or uncontrolled infection. Has a known additional malignancy that is progressing or requires active treatment. Has an underlying medical condition that would preclude study participation.Xx_NEWLINE_xXActive uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are not excludedXx_NEWLINE_xXProcurement: Patients with severe intercurrent infectionXx_NEWLINE_xXPatients with severe intercurrent infectionXx_NEWLINE_xXPatients who have an active or uncontrolled infection are not eligibleXx_NEWLINE_xXPatients with an active or uncontrolled infection.Xx_NEWLINE_xXUncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive and uncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infection, including HIV/AIDS or Hepatitis B or CXx_NEWLINE_xXActive candida infection, including mucocutaneous infection or history of invasive candidiasis. Additional exclusion criteria for Combination arm PDR001+trametinibXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXHave any known active uncontrolled infectionXx_NEWLINE_xXSerious, uncontrolled infectionXx_NEWLINE_xXResearch participants with uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXSubjects who have an uncontrolled infection are not eligibleXx_NEWLINE_xXKnown ongoing or active systemic infection, active hepatitis B or C virus infectionXx_NEWLINE_xXActive or uncontrolled infection.Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXUncontrolled intercurrent active infection; controlled infection on long term suppressive or maintenance therapy is permissibleXx_NEWLINE_xXPROCUREMENT: Patients with severe intercurrent infectionXx_NEWLINE_xXTREATMENT: Patients with severe intercurrent infectionXx_NEWLINE_xXActive serious infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXPatients with a severe intercurrent infectionXx_NEWLINE_xXUncontrolled Grade 3 or higher infectionXx_NEWLINE_xXPoor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.Xx_NEWLINE_xXHave an active, uncontrolled infectionXx_NEWLINE_xXHBV and HVC co-infection, or HBV and Hep D co-infectionXx_NEWLINE_xXSevere infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.Xx_NEWLINE_xXSevere infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXAny active, uncontrolled infection at the time of enrollmentXx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infectionXx_NEWLINE_xXPatients with severe intercurrent infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligible.Xx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection not adequately responding to appropriate therapyXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXEXCLUSION - INFUSION: Severe active intercurrent infectionXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXAt high medical risk because of non-malignant systemic disease including uncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligibleXx_NEWLINE_xXPatients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocolXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXActive infection within one-week prior to study, including unexplained feverXx_NEWLINE_xXPresence of a serious acute infection or chronic infectionXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding diatheses, or active infection.Xx_NEWLINE_xXUncontrolled infection or other serious medical illnesses.Xx_NEWLINE_xXInfection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXActive uncontrolled infection.Xx_NEWLINE_xXAny active or uncontrolled infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXOngoing infection > grade 2Xx_NEWLINE_xXPatient with active or uncontrolled infectionXx_NEWLINE_xXEvidence of active infectionXx_NEWLINE_xXClinically significant active infection or uncontrolled medical conditionXx_NEWLINE_xXActive uncontrolled infection.Xx_NEWLINE_xXActive infection =< 7 days prior to study entryXx_NEWLINE_xXPatients with active infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXSevere acute infectionXx_NEWLINE_xXPatients with severe intercurrent infectionXx_NEWLINE_xXPatients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)Xx_NEWLINE_xXUncontrolled active life-threatening infection.Xx_NEWLINE_xXConcurrent serious infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXRecent (< 4 weeks) active, documented, cervical infectionXx_NEWLINE_xXPatients with active infectionXx_NEWLINE_xXInfection: Patients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXEvidence of severe of uncontrolled infection.Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXNo evidence of active, uncontrolled infectionXx_NEWLINE_xXActive infection of any kind.Xx_NEWLINE_xXSignificant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimenXx_NEWLINE_xXPresence of active untreated infectionXx_NEWLINE_xXActive and uncontrolled infection at time of transplantation.Xx_NEWLINE_xXPatients that have an active, uncontrolled infection are not eligibleXx_NEWLINE_xXDONOR: Evidence of active infectionXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXNo active or uncontrollable infection.Xx_NEWLINE_xXHistory of refractory systemic infection.Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active or poorly controlled infectionXx_NEWLINE_xXUncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis).Xx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive and uncontrolled infection at time of transplantation.Xx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXUncontrolled ongoing infection.Xx_NEWLINE_xXChronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXSerious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infectionXx_NEWLINE_xXActive and uncontrolled disease (active infection requiring systemic therapy, fever likely secondary to infection within prior 48 hours, uncontrolled hypertension despite adequate medical therapy as judged by the treating physician.Xx_NEWLINE_xXResearch participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infectionsXx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXRecent or ongoing serious infection, including:Xx_NEWLINE_xXActive infection or corneal ulcer (e.g. keratitis)Xx_NEWLINE_xXUncontrolled active infection or uncontrolled invasive fungal infection (positive blood or tissue culture). An infection controlled with an approved or closely monitored antibiotic/antifungal treatment is allowedXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXSerious concurrent illness, including clinically relevant active infectionXx_NEWLINE_xXAny uncontrolled infection or active infection requiring ongoing systemic treatmentXx_NEWLINE_xXPatients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.Xx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXPatients with uncontrolled infection are excludedXx_NEWLINE_xXKnown untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of study entryXx_NEWLINE_xXSevere infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXActive uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant staphylococcus aureus infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXActive uncontrolled infection;Xx_NEWLINE_xXHas active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.Xx_NEWLINE_xXSignificant active infection or immune deficiency (including chronic use of immunosuppressive drugs)Xx_NEWLINE_xXSubject has an untreated or uncontrolled infection defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.Xx_NEWLINE_xXActive or incompletely treated local infection at the planned treatment site(s) and/or systemic infectionXx_NEWLINE_xXUncontrolled serious infection at the time of enrollment; infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, patients do not have signs of infection progression; 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 infectionXx_NEWLINE_xXPatient has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive study treatment or undergo study proceduresXx_NEWLINE_xXPatients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5 degrees Celsius (C) that has not been evaluated for infection up to the day of initial dosing; patients with documented history of tumor fever are accepted provided acute or chronic infection has been excluded as possible cause of the feverXx_NEWLINE_xXUncontrolled, serious active infection at screeningXx_NEWLINE_xXSevere infection within 4 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXActive, uncontrolled infection.Xx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXActive infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigatorXx_NEWLINE_xXActive uncontrolled infection or severe systemic infection (enrollment is possible after control of infection).Xx_NEWLINE_xXActive, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entryXx_NEWLINE_xXActive infection causing fever.Xx_NEWLINE_xXAny uncontrolled infectionXx_NEWLINE_xXPatients must be free of uncontrolled infectionXx_NEWLINE_xXUntreated active infectionXx_NEWLINE_xXActive infection, including any active viral infection, =< 5 days prior to registrationXx_NEWLINE_xXDONOR: Active infectionXx_NEWLINE_xXCurrent evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B and C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy.Xx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXHas an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the subject to receive protocol treatment.Xx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXPatients with active systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXPatients must not have active infection or serious intercurrent medical illness.Xx_NEWLINE_xXPatients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infectionXx_NEWLINE_xXBe presenting with recurrent CMV infection (defined as a new detection of CMV infection in a subject who had at least one previously documented episode of CMV infection posttransplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes (during active surveillance, based on same local laboratory and same sample type). The subject must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients who have an uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infection that would be a contraindication to safe use of high-dose therapyXx_NEWLINE_xXActive infection or corneal ulcerXx_NEWLINE_xXOngoing or active infection;Xx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infectionXx_NEWLINE_xXSevere or uncontrolled concurrent disease, infection or comorbidity.Xx_NEWLINE_xXRecent culture-documented infection requiring intravenous antimicrobials that was completed =< 7 days before the first dose of study drug or any uncontrolled active systemic infection; fever of unknown origin is not an exclusion criterion, as this may be disease-relatedXx_NEWLINE_xXDONOR: Active infectionXx_NEWLINE_xXUntreated active infectionXx_NEWLINE_xXUncontrolled hepatitis B or C infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXUncontrolled active, untreated, or progressive infectionXx_NEWLINE_xXOngoing or active systemic infection or active hepatitis B or C virus infectionXx_NEWLINE_xXPatients should not have any uncontrolled illnesses including ongoing or active infectionXx_NEWLINE_xXNo active or uncontrollable infectionXx_NEWLINE_xXHistory of refractory systemic infectionXx_NEWLINE_xXPresence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, 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.Xx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive, uncontrolled infection; patients with infection controlled with antibiotics are eligibleXx_NEWLINE_xXActive uncontrolled serious infectionXx_NEWLINE_xXMajor medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled serious infection, cardiac disease)Xx_NEWLINE_xXHas any serious or uncontrolled active infectionXx_NEWLINE_xXPatients who have active clinically serious infection > CTCAE grade 2 are not eligibleXx_NEWLINE_xXUncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXHave any active and uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients with active, uncontrolled infectionXx_NEWLINE_xXUncontrolled active, untreated, or progressive infectionXx_NEWLINE_xXPatients who have an uncontrolled serious infection are NOT eligible for either StratumXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive infection not adequately responding to appropriate therapyXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXUntreated active infectionXx_NEWLINE_xXPersistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.Xx_NEWLINE_xXHas an uncontrolled, life-threatening active infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive infection =< 5 days prior to registrationXx_NEWLINE_xXNo clinical evidence of life-threatening infectionXx_NEWLINE_xXActive systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXUntreated active infectionXx_NEWLINE_xXPatients with untreated or uncontrolled life-threatening infectionXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXPatients must not have untreated or uncontrolled life-threatening infectionXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXCurrent evidence of fever or untreated infectionXx_NEWLINE_xXSerious (i.e., >= grade 3) uncontrolled infectionXx_NEWLINE_xXNo uncontrolled infectionXx_NEWLINE_xXPatients with active infectionXx_NEWLINE_xXSubjects must not have any active and uncontrolled infectionXx_NEWLINE_xXPresence of serious infectionXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPresence of an active, uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXEvidence of ongoing, uncontrolled infectionXx_NEWLINE_xXSerious (ie, >= grade 3) uncontrolled infectionXx_NEWLINE_xXActive clinically serious and uncontrolled infection > CTCAE grade 2 uncontrolled with antibioticsXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXSubject has a chronic or acute hepatitis C infection; subject with an old infection that has cleared may be includedXx_NEWLINE_xXSubject has a chronic or acute hepatitis B infection; subject with an old infection that has cleared may be includedXx_NEWLINE_xXDONOR: Evidence of active infectionXx_NEWLINE_xXAT THE TIME OF INFUSION: Severe intercurrent infectionXx_NEWLINE_xXAny active infection or infectious illness unless fully recovered prior to dosing.Xx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection not responding to appropriate therapy as determined by study chairXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXSubjects who have an uncontrolled infection are not eligibleXx_NEWLINE_xXTREATMENT: Severe intercurrent infectionXx_NEWLINE_xXPresence of any untreated systemic infectionXx_NEWLINE_xXActive infection that is not responding to antimicrobial therapyXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligible.Xx_NEWLINE_xXSerious uncontrolled infection > grade 2 (CTCAE v4.0)Xx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infection requiring therapyXx_NEWLINE_xXNo evidence of ongoing, uncontrolled infectionXx_NEWLINE_xXEvidence of ongoing, uncontrolled infectionXx_NEWLINE_xXCurrent infectionXx_NEWLINE_xXUncontrolled infections; patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and/or culture) that the infection is well controlledXx_NEWLINE_xXPresence of active or chronic infectionXx_NEWLINE_xXPROCUREMENT: Patients with severe active infectionXx_NEWLINE_xXTREATMENT: Patients with severe active infectionXx_NEWLINE_xXEvidence of untreated infectionXx_NEWLINE_xXActive clinically serious and uncontrolled infectionXx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXNo uncontrolled intercurrent illness or infectionXx_NEWLINE_xXResearch participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infectionsXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXUncontrolled intercurrent illness including active infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXInfection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.Xx_NEWLINE_xXActive herpes zoster infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXUncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive infection =< 5 days prior to registrationXx_NEWLINE_xXPatients with an active infection or with a fever ? 38.5°C within 3 days of the first scheduled day of dosing.Xx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXActive infection or unexplained feverXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXPatients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)Xx_NEWLINE_xXPatients with active infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXNo active infectionXx_NEWLINE_xXEvidence of active infection or serious infection within the past monthXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXRECIPIENT: Active infection refractory to antimicrobial therapyXx_NEWLINE_xXSerious uncontrolled infection > grade 2 (CTCAE v4.0)Xx_NEWLINE_xXPatients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one monthXx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXPatients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapyXx_NEWLINE_xXActive infectionXx_NEWLINE_xXActive or uncontrolled infectionXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory supportXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXPatients who have an uncontrolled infectionXx_NEWLINE_xXSevere/uncontrolled concurrent illness/infectionXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXUncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory supportXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalizationXx_NEWLINE_xXUnexplained fever and/or untreated, active infectionXx_NEWLINE_xXPatients has an active infection or serious intercurrent medical illnessXx_NEWLINE_xXPatients with active, uncontrolled infection are not eligible for this studyXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXHave an active, uncontrolled infectionXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXActive and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infectionXx_NEWLINE_xXPatients with uncontrolled infectionXx_NEWLINE_xXPatients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection; if patient develops an infection requiring antibiotic treatment while on the treatment portion of the study patients will be treated for the active infection with antibiotics and will resume vaccine treatment when the infection is healedXx_NEWLINE_xXConcurrent serious infectionXx_NEWLINE_xXActive systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXSevere life, threatening infectionXx_NEWLINE_xXSevere life, threatening infectionXx_NEWLINE_xXActive uncontrolled infection.Xx_NEWLINE_xXActive infection that is not responding to antimicrobial therapyXx_NEWLINE_xXPresence of active untreated infectionXx_NEWLINE_xXEvidence of active acute or chronic infectionXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXActive and uncontrolled infection at time of transplantationXx_NEWLINE_xXActive, uncontrolled infection (e.g. Hepatitis A, B, or C)Xx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXPresence of active infectionXx_NEWLINE_xXActive infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)Xx_NEWLINE_xXActive infection at time of transplantation (including active infection with aspergillus or other mold within 30 days)Xx_NEWLINE_xXCurrent active serious infectionXx_NEWLINE_xXPatients with an uncontrolled life-threatening infectionXx_NEWLINE_xXNo other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safetyXx_NEWLINE_xXSerious concurrent illness, including clinically relevant active infectionXx_NEWLINE_xXPatients with active systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXThe patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).Xx_NEWLINE_xXPersistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.Xx_NEWLINE_xXActive clinically significant uncontrolled infectionXx_NEWLINE_xXPatients with an active infection or severe hematological, neurological, or other uncontrolled disease.Xx_NEWLINE_xXUncontrolled active infection;Xx_NEWLINE_xXSerious active infectionXx_NEWLINE_xXPresence of serious infectionXx_NEWLINE_xXActive infection.Xx_NEWLINE_xXPatients with an active infectionXx_NEWLINE_xXPatients who have severe infections within 4 weeks before initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;\r\n* Exception: uncomplicated urinary tract infection will not be considered as a severe infection in these patientsXx_NEWLINE_xXSevere infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXSubjects with bacteremia with documented microbiological evidence of another source of infection (eg, osteomyelitis, pneumonia, skin infection, urinary tract infection, joint infection, or abdominal infection) known to be due to the same organism cultured from the blood;Xx_NEWLINE_xXPresence of active infectionXx_NEWLINE_xXKnown HIV infection or active infection with hepatitis B or C. Patients with unknown status at the time of enrollment must be tested during screening.Xx_NEWLINE_xXSubjects with uncontrolled, systematic infection should be excludedXx_NEWLINE_xXPatients with an active or uncontrolled infection.Xx_NEWLINE_xXActive infection, chronic or severe infection requiring ongoing antimicrobial therapy.Xx_NEWLINE_xXSubjects who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive uncontrolled infection or severe infection disease (e.g., severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection)Xx_NEWLINE_xXActive pneumonitis or uncontrolled infectionXx_NEWLINE_xXNo evidence of clinically significant active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXRecent culture-documented infection requiring systemic intravenous treatment that was completed =< 7 days before the first dose of study drug or any uncontrolled active systemic infection; fever of unknown origin is not an exclusion criterion, as this may be disease-relatedXx_NEWLINE_xXSerious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXSevere or uncontrolled intercurrent illness/infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection or other medical condition that would make prednisone use contraindicatedXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatient must not have an active, uncontrolled infectionXx_NEWLINE_xXPatients who have an active uncontrolled infection defined as: \r\n* Positive bacterial blood culture within 48 hours of study enrollment; \r\n* Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability\r\n* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\r\n* Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (c.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline\r\n* Active viral or protozoal infection requiring IV treatmentXx_NEWLINE_xXActive untreated infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection =< 5 days prior to registrationXx_NEWLINE_xXARM A: Uncontrolled infectionXx_NEWLINE_xXARM B: Uncontrolled infectionXx_NEWLINE_xXActive infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)Xx_NEWLINE_xXActive, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligibleXx_NEWLINE_xXPatients with documented active, uncontrolled infection at the time of study entryXx_NEWLINE_xXActive infectionXx_NEWLINE_xXActive infection not adequately responding to appropriate therapy.Xx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXPatients with active infection are ineligibleXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive infection =< 5 days prior to registrationXx_NEWLINE_xXPatients who have an active or uncontrolled infection are excludedXx_NEWLINE_xXPatients must not have documented evidence of acute hepatitis or have an active or uncontrolled infectionXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as any active (acute or chronic) or uncontrolled infection/ disorders or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapyXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXOngoing infection > grade 2Xx_NEWLINE_xXUncontrolled systemic illness, including but not limited to ongoing or active infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive serious infectionXx_NEWLINE_xXPatients must not have documented evidence of acute hepatitis or have an active or uncontrolled infectionXx_NEWLINE_xXSubjects who have an active clinically serious infection of CTCAE grade >= 2Xx_NEWLINE_xXPatients must not have documented evidence of acute hepatitis or have an active or uncontrolled infectionXx_NEWLINE_xXPatients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)Xx_NEWLINE_xXPatients with the presence of an active infection, abscess or fistulaXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXSubject has active, uncontrolled infectionXx_NEWLINE_xXActive urinary tract infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infection other than HIVXx_NEWLINE_xXActive, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligibleXx_NEWLINE_xXActive infection: temperature > 100 Fahrenheit (F), fever of unknown origin, active symptoms or signs of infection as defined by the investigatorXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatient may have no active uncontrollable systemic infectionXx_NEWLINE_xXActive ear/sinus infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXPatient has an uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXEvidence of ongoing, uncontrolled infectionXx_NEWLINE_xXPatients with active infectionXx_NEWLINE_xXTreatment with appropriate antiviral therapy for patients with active HBV infection is requiredXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXPatients with an uncontrolled serious infectionXx_NEWLINE_xXPresence of any serious or uncontrolled infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXSubjects with an active infectionXx_NEWLINE_xXPatients with any other known active cancer (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, pulmonary, chronic renal disease, active uncontrolled infection)Xx_NEWLINE_xXUntreated systemic infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXActive infection that is not responding to antimicrobial therapyXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXHepatitis B or C infection (HBV), or untreated systemic infectionXx_NEWLINE_xXSerious concurrent illness or clinically relevant active infection as defined in the protocolXx_NEWLINE_xXSubject has an active uncontrolled infection.Xx_NEWLINE_xXPresence of an active infection; patients with fever assessed to be \tumor fever\ but without active evidence of infection (e.g. blood cultures are negative) are eligible; in addition, patients who have an infection but without evidence of fever for 48 hours on antibiotics will be eligibleXx_NEWLINE_xXPatients with uncontrolled infectionXx_NEWLINE_xXActive infection not well controlled by antibacterial or antiviral therapy.Xx_NEWLINE_xXPatients must not have active, uncontrolled infectionXx_NEWLINE_xXRecent or ongoing serious infection, including:Xx_NEWLINE_xXPatients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocolXx_NEWLINE_xXHas dual active HBV infection and HCV infection at study entry.Xx_NEWLINE_xXPresence of active infection within 72 hoursXx_NEWLINE_xXPresence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.Xx_NEWLINE_xXThey have active diarhhea.Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.Xx_NEWLINE_xXActive Grade 3 or higher infection.Xx_NEWLINE_xXPresence of any active or ongoing infectionXx_NEWLINE_xXSubject has active, uncontrolled infectionXx_NEWLINE_xXActive, unresolved infectionXx_NEWLINE_xXActive uncontrolled infection, including HIV/AIDS or Hepatitis B or CXx_NEWLINE_xXHave evidence of uncontrolled, active infection <7 days prior to administration of study medication.Xx_NEWLINE_xXActive infection or corneal ulcer (e.g., keratitis)Xx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXParticipants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXPatients with an active, uncontrolled systemic infection are not eligible until deemed controlled by the treating physicianXx_NEWLINE_xXSevere or uncontrolled concurrent disease, infection or co-morbidity.Xx_NEWLINE_xXPatients are ineligible if they have an active infectionXx_NEWLINE_xXAbsence of uncontrolled infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXRecent or ongoing serious infectionXx_NEWLINE_xXConcurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.Xx_NEWLINE_xXHave an ongoing or active infection.Xx_NEWLINE_xXLife expectancy severely limited by concomitant illness or uncontrolled infectionXx_NEWLINE_xXOngoing or active infection;Xx_NEWLINE_xXActive infection;Xx_NEWLINE_xXActive infection or past hepatitis B or C infectionXx_NEWLINE_xXPresence of active serious infection;Xx_NEWLINE_xXActive infection not adequately responding to appropriate therapy.Xx_NEWLINE_xXActive or uncontrolled infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection or renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.Xx_NEWLINE_xXSevere infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXhave a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection, including chronic viral hepatitisXx_NEWLINE_xXPresence of an active uncontrolled infection.Xx_NEWLINE_xXActive uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.Xx_NEWLINE_xXSerious active infection, or serious underlying medical condition.Xx_NEWLINE_xXPresence of active clinically serious infectionXx_NEWLINE_xXUrinary tract infection, including particularly bladder infection, must be resolved prior to being placed on studyXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXInfectionXx_NEWLINE_xXPatients with active or uncontrolled systemic infection.Xx_NEWLINE_xXPatients with ongoing or active infectionXx_NEWLINE_xXAny other concurrent severe known disease (except carcinoma in-situ) or concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, or active uncontrolled infection) which could compromise participation in the studyXx_NEWLINE_xXMajor or uncontrolled comorbid conditions as determined by the treating physician:\r\n* History of ventricular arrhythmias requiring drug or device therapy\r\n* Uncontrolled angina or symptomatic congestive heart failure\r\n* Severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection\r\n* Severe or uncontrolled psychiatric illnessXx_NEWLINE_xXPatients must not have uncontrolled infectionXx_NEWLINE_xXPatients with an active infection.Xx_NEWLINE_xXClinical objective evidence of bacterial infection and a known site of infection.Xx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXSevere or uncontrolled medical conditions (i.e., uncontrolled diabetes, active or uncontrolled infection)Xx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXUncontrolled infection, fever > 100 degrees F; or antibiotic therapy < 72 hours prior to registration; or urinary tract infection < 72 hours prior to registrationXx_NEWLINE_xXUncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapyXx_NEWLINE_xXAcute or chronic active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatmentXx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infectionXx_NEWLINE_xXSubject has an active uncontrolled infection. If an infection is present, the patient must be receiving definitive therapy and have no signs of progressing infection. 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.Xx_NEWLINE_xXNo active systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXFree of active uncontrolled infection at the time of study entryXx_NEWLINE_xXNo uncontrolled infection\r\n* Note: infection is permitted if there is evidence of response to medication; eligibility of human immunodeficiency virus (HIV) infected patients will be determined on a case-by-case basisXx_NEWLINE_xXPatients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)Xx_NEWLINE_xXCurrent systemic infection or suspicion of active bacterial infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXActive infection that would impair the ability of the patient to receive study treatmentXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatient has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment.Xx_NEWLINE_xXPatients must not have untreated or uncontrolled life-threatening infectionXx_NEWLINE_xXUncontrolled infection within 14 days before study enrollment\r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterionXx_NEWLINE_xXUncontrolled infection within 14 days prior to enrollment \r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterionXx_NEWLINE_xXConcomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illnessXx_NEWLINE_xXSerious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosisXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXUncontrolled or current infectionXx_NEWLINE_xXPatients who have an uncontrolled infection, or who are currently receiving treatment for Clostridium (C) difficile infectionXx_NEWLINE_xXUncontrolled infection or significant co-morbidity (e.g., uncontrolled diabetes, severe diarrhea that requires total parenteral nutrition [TPN])Xx_NEWLINE_xXActive (acute or chronic) or uncontrolled severe infectionXx_NEWLINE_xXClinically significant comorbidities such as uncontrolled pulmonary disease, active central nervous system disease, active infection, serious infection within 14 days before the first dose of study drug, or any other condition that could compromise study participation by the participant.Xx_NEWLINE_xXAny uncontrolled active systemic infection.Xx_NEWLINE_xXOngoing infection >= grade 2Xx_NEWLINE_xXThe patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease)Xx_NEWLINE_xXUncontrolled active infection within one week prior to first doseXx_NEWLINE_xXUncontrolled medical disease(s) or active, uncontrolled infectionXx_NEWLINE_xXActive infection that would impair the ability of the patient to receive study treatmentXx_NEWLINE_xXSubjects who have an uncontrolled infectionXx_NEWLINE_xXAT THE TIME OF INFUSION: Severe intercurrent infectionXx_NEWLINE_xXActive infection > CTCAE Grade 2, that is considered clinically serious by the treating physicianXx_NEWLINE_xXThe presence of co-existing medical conditions that would limit compliance with study medications, including, but not limited to active infection, active or untreated cardiac or pulmonary disease, or malignancyXx_NEWLINE_xXPatients with serious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXActive and uncontrolled infection; patients with an active infection receiving treatment and hemodynamically stable for 48 hours may be entered into the studyXx_NEWLINE_xXPatients with uncontrolled infection are excludedXx_NEWLINE_xXActive uncontrolled serious infection or sepsis at study enrollmentXx_NEWLINE_xXSerious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosisXx_NEWLINE_xXPatient has evidence of active systemic, pulmonary, or pericardial infection.Xx_NEWLINE_xXSubject has an active uncontrolled infection.Xx_NEWLINE_xXCo-infection of HBV and HCVXx_NEWLINE_xXActive and uncontrolled disease (other than AML) or infection as judged by the treating physicianXx_NEWLINE_xXEvidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past monthXx_NEWLINE_xXActive unresolved infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive uncontrolled serious infection or sepsis at study enrollmentXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXSevere acute infectionXx_NEWLINE_xXActive Infection with HBV or HCVXx_NEWLINE_xXPatients with uncontrolled infections for whom myeloablative hematopoietic stem cell transplant (HCT) is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)Xx_NEWLINE_xXActive, unresolved infectionXx_NEWLINE_xXPatients with any active, uncontrolled infection are NOT eligible for participationXx_NEWLINE_xXActive opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosingXx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXUncontrolled, life-threatening infection that is not responding to antimicrobial therapyXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXActive dental infectionXx_NEWLINE_xXAny evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.Xx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXUncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory supportXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXActive or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs.Xx_NEWLINE_xXCurrent evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXActive life-threatening infectionXx_NEWLINE_xXSevere or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection)Xx_NEWLINE_xXNo ongoing or active infection at study entryXx_NEWLINE_xXActive serious infectionXx_NEWLINE_xXNo previous evidence of opportunistic infectionXx_NEWLINE_xXActive, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entryXx_NEWLINE_xXSevere active viral infection, especially hepatitis B; severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of randomization; contact the national co-investigator for further advice if necessaryXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXNo active uncontrolled infectionXx_NEWLINE_xXPatients who have an uncontrolled or untreated infection are not eligibleXx_NEWLINE_xXActive infection or intercurrent illnessXx_NEWLINE_xXThe patient has an uncontrolled infection, or is receiving anti-fungal treatment for an ongoing infectionXx_NEWLINE_xXNo uncontrolled infection; protocol principal investigator (PI) or designee will be final arbiter if there is uncertainty regarding whether a previous infection is controlled on appropriate (antibiotic) therapyXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values that could in the opinion of the investigator cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXPatients must not have active infection or serious intercurrent medical illnessXx_NEWLINE_xXActive, uncontrolled systemic infectionXx_NEWLINE_xXEvidence of an active pulmonary, gastrointestinal, genitourinary, or other serious infection at time of enrollmentXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXActive infectionXx_NEWLINE_xXKnown active infection, or major episode of infection within 4 week prior to the start of Cycle 1Xx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXNo active serious infection or other comorbid illness which would impair ability to participate in the trialXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXPatients must have an expected survival of > 60 days and must be free of active infectionXx_NEWLINE_xXUncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, or need for ventilatory supportXx_NEWLINE_xXHave ongoing or active infectionXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease or HIV infectionXx_NEWLINE_xXNo evidence of acute infectionXx_NEWLINE_xXPatients who have uncontrolled active infectionXx_NEWLINE_xXThe subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).Xx_NEWLINE_xXSerious active infection or gastrointestinal diseaseXx_NEWLINE_xXActive infection\r\n* Active infection includes patients with positive blood culturesXx_NEWLINE_xXSubjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;Xx_NEWLINE_xXAny uncontrolled active systemic infection or recent infection requiring intravenous anti-infective treatment that was completed =< 14 days before the first dose of study drugXx_NEWLINE_xXActive/chronic HBV or HCV infection;Xx_NEWLINE_xXPatients must not have untreated or uncontrolled life-threatening infectionXx_NEWLINE_xXActive untreated infectionXx_NEWLINE_xXNo untreated or uncontrolled life-threatening infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXUncontrolled, life-threatening infection that is not responding to antimicrobial therapyXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXNo active infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXSevere intercurrent infectionXx_NEWLINE_xXactive urinary tract infection;Xx_NEWLINE_xXPatients must have an expected survival of > 60 days and must be free of active infectionXx_NEWLINE_xXActive infection that is not responding to antimicrobial therapyXx_NEWLINE_xXUncontrolled active infection or illnessXx_NEWLINE_xXPatients with uncontrolled infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXPatients with an uncontrolled life-threatening infectionXx_NEWLINE_xXPatients with severe and/or uncontrolled medial disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection [persistent fever and worsening clinical condition])Xx_NEWLINE_xXPatients with an active or uncontrolled infection.Xx_NEWLINE_xXSubjects with an active uncontrolled infection.Xx_NEWLINE_xXEvidence of ongoing active infectionXx_NEWLINE_xXOther active disease including but not limited to ulceration of the upper gastrointestinal tract, autoimmune disease, HIV infection, active HBV and HCV infection.Xx_NEWLINE_xXHave uncontrolled hepatitis B or C infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXActive and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infectionXx_NEWLINE_xXEvidence of an ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the time of start of study therapyXx_NEWLINE_xXActive major systemic or local uncontrolled infectionXx_NEWLINE_xXAny active, severe local or systemic infection at the screening visitXx_NEWLINE_xXActive infectionXx_NEWLINE_xXKnown active uncontrolled systemic infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXPatients with any concurrent severe and/or uncontrolled medical condition or active uncontrolled systemic infection as determined by the investigatorXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXAny evidence of serious active infection.Xx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXKnown active systemic infection (Grade ?2).Xx_NEWLINE_xXHIV infection (due to increased risk of severe infection and unknown interaction of moxetumomab pasudotox with antiretroviral drugs)Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXUncontrolled, life-threatening infection that is not responding to antimicrobial therapyXx_NEWLINE_xXPrior systemic infection with BCGXx_NEWLINE_xXSevere systemic infection (i.e., sepsis)Xx_NEWLINE_xXNo evidence of active infection and no serious infection within the past monthXx_NEWLINE_xXEvidence of active infection, or serious infection within the past monthXx_NEWLINE_xXActive and uncontrolled disease/infection as judged by the treating physicianXx_NEWLINE_xXActive, clinically serious infection greater than CTCAE grade 2. Patients may be eligible upon resolution of the infection.Xx_NEWLINE_xXPatients with uncontrolled infection or systemic diseaseXx_NEWLINE_xXPresence of infection other than the infection of the bile duct (cholangitis)Xx_NEWLINE_xXAcute, active infection within 14 days of enrollmentXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXUncontrolled opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosingXx_NEWLINE_xXSubject has an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.Xx_NEWLINE_xXHave a significant uncontrolled infection active infectionXx_NEWLINE_xXThe patient has an uncontrolled and active infection that would preclude study conduct and assessmentXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXHave significant, uncontrolled active infectionXx_NEWLINE_xXPatients with active lung infection or active pulmonary edemaXx_NEWLINE_xXUncontrolled active infectionXx_NEWLINE_xXPatients with active, uncontrolled infectionXx_NEWLINE_xXPresence of uncontrolled infection.Xx_NEWLINE_xXActive infection within 14 days prior to scheduled treatmentXx_NEWLINE_xXSerious uncontrolled active infectionXx_NEWLINE_xXKnown active meningeal infectionXx_NEWLINE_xXSerious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXUncontrolled or serious infectionXx_NEWLINE_xXHas an active, uncontrolled infection;Xx_NEWLINE_xXActive serious infection (pulmonary infiltrates or lesions are allowed only after the appropriate diagnostic testing is negative for infection or appropriate therapy was initiated for probable infection)Xx_NEWLINE_xXConcurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollmentXx_NEWLINE_xXHistory of prior systemic BCG infectionXx_NEWLINE_xXPatients with acute or chronic infectionXx_NEWLINE_xXActive or uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXHistory of HIV infection or acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelinesXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXActive uncontrolled infection at time of enrollment or documented fungal infection within 3 monthsXx_NEWLINE_xXPatients with active or uncontrolled systemic infection.Xx_NEWLINE_xXUncontrolled infection within 4 weeks prior to randomizationXx_NEWLINE_xXPatients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.).Xx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXPatient has an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, HIV infection, chronic liver disease. chronic renal disease, pancreatitis, chronic pulmonary disease, active cardiac disease or cardiac dysfunction, interstitial lung disease, active autoimmune disease, uncontrolled diabetes, neuropsychiatric or social situations that would limit compliance with the study requirements.Xx_NEWLINE_xXUncontrolled, life-threatening infection that is not responding to antimicrobial therapyXx_NEWLINE_xXNo active infectionXx_NEWLINE_xXActive infection including cytomegalovirusXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXOther significant active infection.Xx_NEWLINE_xXPatients with sepsis or severe infectionXx_NEWLINE_xXUncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivationXx_NEWLINE_xXPatients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIVXx_NEWLINE_xXActive untreated infectionXx_NEWLINE_xXConcurrent serious infectionXx_NEWLINE_xXEvidence of ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the start of study.Xx_NEWLINE_xXPatients must not have documented evidence of acute hepatitis or have an active or uncontrolled infectionXx_NEWLINE_xXActive AIDS / HIV infection, clinically uncontrolled immune deficiency disorders;Xx_NEWLINE_xXActive urinary tract infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXInfection:\r\n* Local infection at the puncture site\r\n* Systemic infection, osteomyelitis, discitisXx_NEWLINE_xXActive infectionXx_NEWLINE_xXConcurrent active infectionXx_NEWLINE_xXActive or uncontrolled infection. Patients with any infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.Xx_NEWLINE_xXSerious infection within 14 days before the first dose of study drug. Participant must have recovered from infection before first dose.Xx_NEWLINE_xXHigh medical risks because of non-malignant systemic disease or with active uncontrolled infection;Xx_NEWLINE_xXActive uncontrolled infection or severe infectious disease, such as pneumonia, meningitis, septicemia, or methicillin-resistant Staphylococcus aureus infection.Xx_NEWLINE_xXPatients with active infection at time of biopsyXx_NEWLINE_xXUncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivationXx_NEWLINE_xXAny active, severe local or systemic infection at the screening visitXx_NEWLINE_xXSubject has an active uncontrolled infectionXx_NEWLINE_xXActive infection not controlled with appropriate antimicrobial therapyXx_NEWLINE_xXNo active infectionXx_NEWLINE_xXUncontrolled infection or systemic disease.Xx_NEWLINE_xXOther significant active infection.Xx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infection or severe infectious diseaseXx_NEWLINE_xXActive uncontrolled infection;Xx_NEWLINE_xXPresence of active, uncontrolled infection.Xx_NEWLINE_xXActive infection.Xx_NEWLINE_xXActive uncontrolled infection or severe infectious diseaseXx_NEWLINE_xXClinical Pulmonary Infection Score (CPIS) of at least 6Xx_NEWLINE_xXSevere or uncontrolled systemic infectionXx_NEWLINE_xXHistory of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.Xx_NEWLINE_xXActive uncontrolled opportunistic infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXKnown active infection.Xx_NEWLINE_xXInfectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXOngoing infection > grade 2Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients should not have any clinical evidence of an active infection at the time of enrollmentXx_NEWLINE_xXActive infection, ascites, hepatic encephalopathyXx_NEWLINE_xXPatient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active, uncontrolled infection.Xx_NEWLINE_xXAny active or uncontrolled infectionXx_NEWLINE_xXPatients with active pulmonary or pericardial infectionXx_NEWLINE_xXOther clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active CNS disease, active infection or any other condition that could compromise the patients participation in the study according to the investigatorXx_NEWLINE_xXKnown active infectionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXEvidence of active infectionXx_NEWLINE_xXDonor must not have an active infection at the time of study entry.Xx_NEWLINE_xXConcomitant diseases/conditions: a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.Xx_NEWLINE_xXInfectionXx_NEWLINE_xXNo uncontrolled infection\r\n* Note: Infection is permitted if there is evidence of response to medication; eligibility of human immunodeficiency virus (HIV) infected patients will be determined on a case-by-case basisXx_NEWLINE_xXPresence of uncontrolled infection.Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXInfectionXx_NEWLINE_xXHave a chronic underlying infectionXx_NEWLINE_xXActive clinically serious infection > CTCAE v 4.0 grade 2Xx_NEWLINE_xXUncontrolled concurrent illness including: other hematologic or non-hematologic malignancy, active infection, or uncontrolled diabetesXx_NEWLINE_xXA serious active infection (> grade 2) within 7 days of enrollmentXx_NEWLINE_xXSerious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXPresence of active infectionXx_NEWLINE_xXUntreated bladder infectionXx_NEWLINE_xXOngoing or active infectionXx_NEWLINE_xXPresence of uncontrolled infectionXx_NEWLINE_xXCurrently active infectionXx_NEWLINE_xXActive systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXDocumented or suspected infectionXx_NEWLINE_xXActive infection that is not responding to antimicrobial therapyXx_NEWLINE_xXActive infectionXx_NEWLINE_xXSerious active infection at the time of pre-study screening.Xx_NEWLINE_xXNo serious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXUncontrolled infection;Xx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXHave an uncontrolled infectionXx_NEWLINE_xXAn uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXActive or uncontrolled infectionXx_NEWLINE_xXActive or uncontrolled infection. Patients with any infection receiving treatment (antibiotic,antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.Xx_NEWLINE_xXAny clinically significant uncontrolled illness including ongoing active infectionXx_NEWLINE_xXPatients who have an uncontrolled infection are not eligibleXx_NEWLINE_xXActive infection with hepatitis A, B, or C; active infection is defined as serologic positivity and elevated liver function testsXx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXActive infectionXx_NEWLINE_xXHave an active urinary tract infection (UTI),Xx_NEWLINE_xXPatients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)Xx_NEWLINE_xXAny evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent)Xx_NEWLINE_xXActive lung infectionXx_NEWLINE_xXPatients with an active infection or severe hematological, neurological, or other uncontrolled disease.Xx_NEWLINE_xXOngoing or active infection.Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.Xx_NEWLINE_xXInfection or abscess anywhere in the bodyXx_NEWLINE_xXSubjects with an uncontrolled, active infection; subjects with viremia (cytomegalovirus or other) may be enrolled, provided they are on active therapy and at the discretion of the treating physicianXx_NEWLINE_xXPatients with sepsis or severe infectionXx_NEWLINE_xXActive or uncontrolled pulmonary diseaseXx_NEWLINE_xXNo uncontrolled infection\r\n* Note: infection is permitted if there is evidence of response to medication; eligibility of human immunodeficiency virus (HIV) infected patients will be determined on a case?by?case basisXx_NEWLINE_xXUncontrolled infection at initiation of protocol treatmentXx_NEWLINE_xXCurrent vaginal infectionXx_NEWLINE_xXActive and uncontrolled infection at the time of transplantationXx_NEWLINE_xXPatients with documented infection at time of enrollmentXx_NEWLINE_xXActive InfectionXx_NEWLINE_xXActive cutaneous infection or inflammationXx_NEWLINE_xXLocal or systemic infectionXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infectionXx_NEWLINE_xXPatients must not have an active infectionXx_NEWLINE_xXPatients with uncontrolled infection at the time of study entryXx_NEWLINE_xXActive clinically significant uncontrolled infectionXx_NEWLINE_xXPatients with sepsis or severe infectionXx_NEWLINE_xXSerious, uncontrolled, concurrent infection(s)Xx_NEWLINE_xXKnown active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolvedXx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXPatient is known to have an uncontrolled active systemic infectionXx_NEWLINE_xXActive clinically significant uncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXActive uncontrolled infectionXx_NEWLINE_xXKnown current vaginal infectionXx_NEWLINE_xXPresence of an uncontrolled infection or infection that required intravenous treatment within 7 days of entryXx_NEWLINE_xXActive/uncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXActive, uncontrolled infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXActive infection at time of transplantation (including active infection with aspergillus or other mold within 30 days)Xx_NEWLINE_xXKnown or suspected active pelvic infectionXx_NEWLINE_xXInfection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.Xx_NEWLINE_xXPresence of an active uncontrolled infection.Xx_NEWLINE_xXActive infection.Xx_NEWLINE_xXActive and uncontrolled infectionXx_NEWLINE_xXActive infection not controlled with appropriate antimicrobial therapyXx_NEWLINE_xXEvidence of uncontrolled active infectionXx_NEWLINE_xXActive infection not controlled with appropriate antimicrobial therapyXx_NEWLINE_xXAn active infection or with a fever ? 38.5°CXx_NEWLINE_xXInfection: patients with documented uncontrolled infection at the time of study entry are not eligibleXx_NEWLINE_xXPatient is receiving antibiotic therapy for an active infectionXx_NEWLINE_xXAre not aware of HBV infectionXx_NEWLINE_xXSubjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)Xx_NEWLINE_xXUntreated active infectionXx_NEWLINE_xXInfection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.Xx_NEWLINE_xXInfection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.Xx_NEWLINE_xXActive systemic infection or skin infection at or near the acupuncture sitesXx_NEWLINE_xXInfection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled.Xx_NEWLINE_xXPatients with severe intercurrent infectionXx_NEWLINE_xXKnown human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.Xx_NEWLINE_xXHave active uncontrolled infection; an active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infectionXx_NEWLINE_xXPresence of active infection within 72 hoursXx_NEWLINE_xXSubject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplantXx_NEWLINE_xXHas an uncontrolled infection on the day of randomizationXx_NEWLINE_xXacute systemic infection andXx_NEWLINE_xXClinically active infection; an active infection may alter the biodistribution of 18F-FLTXx_NEWLINE_xXUncontrolled infectionXx_NEWLINE_xXEvidence of active infection within 14 days of study enrollmentXx_NEWLINE_xXOngoing systemic infectionXx_NEWLINE_xXAcute life threatening infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXPatients should not have any uncontrolled illness including ongoing or active infectionXx_NEWLINE_xXNo active skin infectionXx_NEWLINE_xXPatients must not have presence of uncontrolled infectionXx_NEWLINE_xXSerious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infectionXx_NEWLINE_xXNo concomitant infection or other serious major systemic illnessXx_NEWLINE_xXPatient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infectionXx_NEWLINE_xXRecognized concurrent active infectionXx_NEWLINE_xXPatient must not have an uncontrolled infectionXx_NEWLINE_xXActive infectionXx_NEWLINE_xXSevere infection requiring systemic treatment within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaXx_NEWLINE_xXInfection is a common feature of AML; patients with active infection are permitted to enroll provided that the infection is controlled; patients with uncontrolled infection shall not be enrolled until infection is treated and brought under controlXx_NEWLINE_xXAny concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.Xx_NEWLINE_xXAny uncontrolled active systemic infectionXx_NEWLINE_xXEvidence of severe uncontrolled systemic disease, bleeding diatheses, renal or liver transplant, active infection with hep B or C or HIVXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatients with active systemic, pulmonary, or pericardial infectionXx_NEWLINE_xXPatients that have recognized concurrent active infectionXx_NEWLINE_xXAs judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), serious active infection or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions and infectious diseases is not requiredXx_NEWLINE_xXPatients with sepsis or severe infectionXx_NEWLINE_xXActive infection or chronic comorbidity that would interfere with therapyXx_NEWLINE_xXActive infectionXx_NEWLINE_xXPatient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infectionXx_NEWLINE_xXInfection: Subjects with uncontrolled infection not eligibleXx_NEWLINE_xXActive, uncontrolled infection or severe infectious disease.Xx_NEWLINE_xXThe patient has another concurrent illness that would preclude study conduct and assessment, including, but not limited to, another active malignancy (excluding squamous or basal cell skin cancer and in situ cervical cancer), uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, or uncontrolled diabetes mellitus.Xx_NEWLINE_xXActive infectionXx_NEWLINE_xXRecent or ongoing serious infection.Xx_NEWLINE_xX