--- a +++ b/clusters/3009knumclusters/clust_221.txt @@ -0,0 +1,783 @@ +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Presence of an active uncontrolled infection. +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +STEP I: Patients must not have active, uncontrolled infection +Patients 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 protocol +Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection +Patient must not have an active uncontrolled infection +Patients 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 infection +Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Patients with uncontrolled infection +Any active acute or chronic or uncontrolled infection +Patients with active, uncontrolled infection +Subject has an active infection +Active HBV or HCV infection. +Unstable systemic disease or active uncontrolled infection +Active uncontrolled infection; +Patients 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) +Active infection +Patients with uncontrolled infection +No evidence of intercurrent infection +Has 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. +Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are not excluded +Patients who have an active or uncontrolled infection are not eligible +Patients with an active or uncontrolled infection. +Uncontrolled illness including ongoing or active infection +Active and uncontrolled infection +Active, uncontrolled infection +Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C +Active candida infection, including mucocutaneous infection or history of invasive candidiasis. Additional exclusion criteria for Combination arm PDR001+trametinib +Uncontrolled infection +Have any known active uncontrolled infection +Serious, uncontrolled infection +Research participants with uncontrolled infection +Active infection +Subjects who have an uncontrolled infection are not eligible +Known ongoing or active systemic infection, active hepatitis B or C virus infection +Ongoing or active infection; the requirement for intravenous (IV) antibiotics is considered active infection +Active or uncontrolled infection. +Known active infection requiring parenteral or oral anti-infective treatment, once a patient has completed antibiotics and symptoms of infection have resolved to < grade 2, they are then considered eligible from an infection standpoint +Uncontrolled intercurrent active infection; controlled infection on long term suppressive or maintenance therapy is permissible +Patients with active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing; +Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection. +Ongoing active infection; the requirement for intravenous (IV) antibiotics is considered active infection +Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) +Active serious infection +Active uncontrolled infection +Uncontrolled Grade 3 or higher infection +Have an active, uncontrolled infection +HBV and HVC co-infection, or HBV and Hep D co-infection +Any active, uncontrolled infection at the time of enrollment +Any serious or uncontrolled medical disorder or active infection +The patient has any ongoing or active infection, including active tuberculosis; Note: a urinary tract infection controlled with oral antibiotics initiated at least 7 days prior to study entry is acceptable +Patients who have an uncontrolled infection are not eligible. +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Active infection not adequately responding to appropriate therapy +Patients who have an uncontrolled infection are not eligible +Any uncontrolled active systemic infection +Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible +Patients 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 protocol +Any uncontrolled active systemic infection +Active infection within one-week prior to study, including unexplained fever +Presence of a serious acute infection or chronic infection +Patients with evidence of an active bacterial infection or with a fever ? 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing +Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. +Active infection +Active uncontrolled infection. +Any active or uncontrolled infection +Ongoing infection > grade 2 +Patient with active or uncontrolled infection +Evidence of active infection +Active uncontrolled infection. +Active infection =< 7 days prior to study entry +Patients with active infection +Uncontrolled active life-threatening infection. +Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics +Recent (< 4 weeks) active, documented, cervical infection +Patients with active infection +Infection: Patients who have an uncontrolled infection are not eligible +Evidence of severe of uncontrolled infection. +No evidence of active, uncontrolled infection +Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics +Active infection of any kind. +Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen +Presence of active untreated infection +Active and uncontrolled infection at time of transplantation. +Patients that have an active, uncontrolled infection are not eligible +Active and uncontrolled disease/infection as judged by the treating physician +No active or uncontrollable infection. +Active infection +Patients should not have any uncontrolled illness including ongoing or active or poorly controlled infection +Uncontrolled 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). +Active uncontrolled infection +Active and uncontrolled disease/infection as judged by the treating physician +Patients should not have any uncontrolled illness including ongoing or active infection +Active and uncontrolled infection at time of transplantation. +Active uncontrolled infection +Uncontrolled ongoing infection. +Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals +Active 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. +Research 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 infections +Ongoing or active infection +Patients who have an uncontrolled infection are not eligible +Recent or ongoing serious infection, including: +Active infection or corneal ulcer (e.g. keratitis) +Uncontrolled 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 allowed +Patients who have an uncontrolled infection are not eligible +Serious concurrent illness, including clinically relevant active infection +Patients 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. +Active life-threatening infection +Patients with uncontrolled infection are excluded +Known untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of study entry +Uncontrolled infection +Active uncontrolled infection; +Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) +Active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection) +Have uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics. +Active infection at the site to be irradiated +Within 14 days before first dose of protocol-indicated treatment:\r\n* Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics initiated at least 14 days prior to initiation of protocol-indicated treatment are not excluded (e.g. urinary tract infection controlled with antibiotics) +Subject 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. +Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection +Uncontrolled 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 infection +Patient 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 procedures +Patients 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 fever +Uncontrolled, serious active infection at screening +Active, uncontrolled infection. +Active life-threatening infection +Active infection at screening or history of severe infection within the previous 3 months, if clinically relevant at screening as considered by the investigator +Active uncontrolled infection or severe systemic infection (enrollment is possible after control of infection). +Active infection causing fever. +Any uncontrolled infection +Presence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics. +Patients must be free of uncontrolled infection +Untreated active infection +Active infection, including any active viral infection, =< 5 days prior to registration +Active and uncontrolled disease/infection as judged by the treating physician +Clinically active infection (>= grade 2) as judged by the site investigator +Has 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. +Active, uncontrolled infection +Any uncontrolled active systemic infection +Active life-threatening infection +Be 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. +Active infection +Patients who have an uncontrolled infection +Active infection or corneal ulcer +Ongoing or active infection; +Uncontrolled infection +Patients should not have any uncontrolled illness including ongoing or active infection +Patients should not have any uncontrolled illness including ongoing or active infection +Active uncontrolled infection +Recent 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-related +Untreated active infection +Active infection +Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) +Patients with active infection will not be eligible, but may become eligible once infection has resolved and at least 7 days have relapsed after antibiotics use was completed +Any uncontrolled active systemic infection +Uncontrolled active, untreated, or progressive infection +Ongoing or active systemic infection or active hepatitis B or C virus infection +Patients should not have any uncontrolled illnesses including ongoing or active infection +No active or uncontrollable infection +Presence 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. +Any uncontrolled active systemic infection +Patients who have an uncontrolled infection are not eligible +Active, uncontrolled infection; patients with infection controlled with antibiotics are eligible +HIV infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue. If positive test results are not indicative of an active infection, patients can be included. +Active uncontrolled serious infection +Has any serious or uncontrolled active infection +Uncontrolled disease/infection as judged by the treating physician +Have any active and uncontrolled infection +Active infection +Patients with active, uncontrolled infection +Uncontrolled active, untreated, or progressive infection +Patients who have an uncontrolled serious infection are NOT eligible for either Stratum +Patients should not have any uncontrolled illness including ongoing or active infection +Active infection not adequately responding to appropriate therapy +Untreated active infection +Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment. +Has an uncontrolled, life-threatening active infection +Uncontrolled infection +Active infection =< 5 days prior to registration +No clinical evidence of life-threatening infection +Untreated active infection +Patients with untreated or uncontrolled life-threatening infection +Active life-threatening infection +Patients must not have untreated or uncontrolled life-threatening infection +Uncontrolled active infection +Current evidence of fever or untreated infection +Serious (i.e., >= grade 3) uncontrolled infection +No uncontrolled infection +Subjects with an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis A, B or C infection +Patients with active infection +Subjects must not have any active and uncontrolled infection +Presence of serious infection +Uncontrolled active infection +Patients who have an uncontrolled infection are not eligible +Patients with recent (within 14 days) or serious ongoing infection +Presence of an active, uncontrolled infection +Subjects with active infection that requires parenteral antibiotics +Active infection +Active life-threatening infection +Evidence of ongoing, uncontrolled infection +Serious (ie, >= grade 3) uncontrolled infection +Active clinically serious and uncontrolled infection > CTCAE grade 2 uncontrolled with antibiotics +Active and uncontrolled disease/infection as judged by the treating physician +Subject has a chronic or acute hepatitis C infection; subject with an old infection that has cleared may be included +Subject has a chronic or acute hepatitis B infection; subject with an old infection that has cleared may be included +Patients who have an uncontrolled infection are not eligible +Active infection not responding to appropriate therapy as determined by study chair +Uncontrolled infection +Active, uncontrolled infection +Subjects who have an uncontrolled infection are not eligible +Presence of any untreated systemic infection +Active infection that is not responding to antimicrobial therapy +Patients who have an uncontrolled infection are not eligible. +Patients should not have any uncontrolled illness including ongoing or active infection requiring therapy +No evidence of ongoing, uncontrolled infection +Evidence of ongoing, uncontrolled infection +Current infection +Uncontrolled 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 controlled +Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection. +Presence of active or chronic infection +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +TREATMENT: Patients with severe active infection +Evidence of untreated infection +Active clinically serious and uncontrolled infection +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Research 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 infections +Active and uncontrolled disease/infection as judged by the treating physician +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Uncontrolled intercurrent illness including active infection +Active uncontrolled infection +Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. +Active herpes zoster infection +Uncontrolled infection +Active life-threatening infection +Uncontrolled illness including ongoing or active infection +Active uncontrolled infection +Active infection =< 5 days prior to registration +Patients with an active infection or with a fever ? 38.5°C within 3 days of the first scheduled day of dosing. +Uncontrolled active infection +Active infection or unexplained fever +Uncontrolled infection +Patients with active infection +No active infection +Evidence of active infection or serious infection within the past month +Uncontrolled active infection +RECIPIENT: Active infection refractory to antimicrobial therapy +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Active life-threatening infection +Active infection +Active or uncontrolled infection +Patients who have an uncontrolled infection +Presence of uncontrolled infection +Uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization +Unexplained fever and/or untreated, active infection +Patients with active, uncontrolled infection are not eligible for this study +Active life-threatening infection +Ongoing or active infection +Have an active, uncontrolled infection +Any uncontrolled active systemic infection +Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infection +Patients with uncontrolled infection +Patients 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 healed +Active uncontrolled infection. +Active infection that is not responding to antimicrobial therapy +Presence of active untreated infection +Evidence of active acute or chronic infection +Active life-threatening infection +Uncontrolled active infection +Active and uncontrolled infection at time of transplantation +Active, uncontrolled infection (e.g. Hepatitis A, B, or C) +Active uncontrolled infection +Active uncontrolled infection +Active uncontrolled infection +Presence of active infection +Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days) +Active infection at time of transplantation (including active infection with aspergillus or other mold within 30 days) +Current active serious infection +Patients with an uncontrolled life-threatening infection +Serious concurrent illness, including clinically relevant active infection +Active uncontrolled infection +Treated with antibiotics for infection within one week prior to study entry. +Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment. +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Active clinically significant uncontrolled infection +Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. +Serious active infection not controlled by antibiotics +Uncontrolled active infection; +Serious active infection +Presence of serious infection +Active infection. +Patients with an active infection +Subject must have a bloodstream infection with no other apparent source that is not related to an infection at another site that meets one of the following: +Subjects 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; +Presence of active infection +ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Signs or symptoms of systemic systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection +HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection) +Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals. +Known HIV infection or active infection with hepatitis B or C. Patients with unknown status at the time of enrollment must be tested during screening. +Subjects with uncontrolled, systematic infection should be excluded +Patients with an active or uncontrolled infection. +Subjects who have an uncontrolled infection are not eligible +Active pneumonitis or uncontrolled infection +No evidence of clinically significant active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Uncontrolled infection +Serious, uncontrolled, concurrent infection(s) +Subjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participation +Patients who have an uncontrolled infection are not eligible +Active infection +Patient must not have an active, uncontrolled infection +Patients 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 treatment +Active untreated infection +Patients who have an uncontrolled infection are not eligible +Active infection =< 5 days prior to registration +ARM A: Uncontrolled infection +ARM B: Uncontrolled infection +Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days) +Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible +Patients with documented active, uncontrolled infection at the time of study entry +Active infection +Patients receiving any medications or substances to treat active infection +Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled +Active infection-must be afebrile and off antibiotics +Active infection not adequately responding to appropriate therapy. +Uncontrolled infection +Patients with active infection are ineligible +Uncontrolled infection +Active infection =< 5 days prior to registration +Patients who have an active or uncontrolled infection are excluded +Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection +Active uncontrolled infection +Ongoing infection > grade 2 +Uncontrolled systemic illness, including but not limited to ongoing or active infection +Patients should not have any uncontrolled illness including ongoing or active infection +Active serious infection +Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection +Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection +Patients with the presence of an active infection, abscess or fistula +Patients who have an uncontrolled infection are not eligible +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Subject has active, uncontrolled infection +Active urinary tract infection +Patients should not have any uncontrolled illness including ongoing or active infection other than HIV +Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible +Active infection: temperature > 100 Fahrenheit (F), fever of unknown origin, active symptoms or signs of infection as defined by the investigator +Any active infection not controlled by antibiotics +Patients who have an uncontrolled infection are not eligible +Patient may have no active uncontrollable systemic infection +Active ear/sinus infection +Patient has an uncontrolled illness including ongoing or active infection +Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) +Evidence of ongoing, uncontrolled infection +Patients with active infection +Treatment with appropriate antiviral therapy for patients with active HBV infection is required +Patients who have an uncontrolled infection are not eligible +Patients with an active infection or with a fever >= 101.3 F within 3 days of the first scheduled day of protocol treatment +Patients with an uncontrolled serious infection +Presence of any serious or uncontrolled infection +Uncontrolled infection +Subjects with an active infection +Untreated systemic infection +Patients who have an uncontrolled infection are not eligible +Uncontrolled infection +Active infection that is not responding to antimicrobial therapy +Active uncontrolled infection +Hepatitis B or C infection (HBV), or untreated systemic infection +Subject has an active uncontrolled infection. +Presence 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 eligible +Patients with uncontrolled infection +Active infection not well controlled by antibacterial or antiviral therapy. +Patients must not have active, uncontrolled infection +Recent or ongoing serious infection, including: +Patients 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 protocol +Has dual active HBV infection and HCV infection at study entry. +Presence of active infection within 72 hours +Presence 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. +They have active diarhhea. +Active infection +Active infection +Active Grade 3 or higher infection. +Presence of any active or ongoing infection +Subject has active, uncontrolled infection +Active, unresolved infection +Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C +Have evidence of uncontrolled, active infection <7 days prior to administration of study medication. +Active infection or corneal ulcer (e.g., keratitis) +Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI]) +Uncontrolled infection +Evidence of active infection within 2 weeks prior to first dose of study treatment. +Patients with an active, uncontrolled systemic infection are not eligible until deemed controlled by the treating physician +Patients are ineligible if they have an active infection +Absence of uncontrolled infection +Uncontrolled infection +Recent or ongoing serious infection +Have an ongoing or active infection. +Ongoing or active infection; +Active infection; +Active infection or past hepatitis B or C infection +Presence of active serious infection; +Active infection not adequately responding to appropriate therapy. +Active or uncontrolled infection +Presence of an active uncontrolled infection. +Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection). +Serious active infection, or serious underlying medical condition. +Presence of active clinically serious infection +Urinary tract infection, including particularly bladder infection, must be resolved prior to being placed on study +Uncontrolled active infection +Uncontrolled active infection +Infection +Patients with active or uncontrolled systemic infection. +Patients with ongoing or active infection +Patients with active infections including uncontrolled human immunodeficiency virus (HIV) infection, active hepatitis B, C, or any other symptomatic systemic infection requiring active therapy will be excluded from study +Patients must not have uncontrolled infection +Patients with an active infection. +Clinical objective evidence of bacterial infection and a known site of infection. +Patients who have an uncontrolled infection are not eligible +Patients who have an uncontrolled infection are not eligible +Active life-threatening infection +Uncontrolled infection, fever > 100 degrees F; or antibiotic therapy < 72 hours prior to registration; or urinary tract infection < 72 hours prior to registration +Acute or chronic active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatment +Any serious or uncontrolled medical disorder or active infection +Subject 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. +Have active serious infection uncontrolled by antibiotics or antifungals +Free of active uncontrolled infection at the time of study entry +Current systemic infection or suspicion of active bacterial infection +Active, uncontrolled infection +Active infection that would impair the ability of the patient to receive study treatment +Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed) +Active infection +Patient 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. +Active infection, including unexplained fever (temperature > 38.5 deg.C). +Patients must not have untreated or uncontrolled life-threatening infection +Uncontrolled 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 criterion +Uncontrolled 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 criterion +Active infection or antibiotics within 48 hours prior to study +Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. +Serious, 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 cirrhosis +Active uncontrolled infection +Uncontrolled or current infection +Patients who have an uncontrolled infection, or who are currently receiving treatment for Clostridium (C) difficile infection +Uncontrolled active infection requiring parenteral antibiotics, antivirals or antifungals within 1 week prior to the first date of study treatment +Active (acute or chronic) or uncontrolled severe infection +Clinically 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. +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose +Any uncontrolled active systemic infection. +Ongoing infection >= grade 2 +Presence of active infection within 72 hours of treatment; patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications +Subjects with active infection that requires parenteral antibiotics +Uncontrolled active infection within one week prior to first dose +Active infection that would impair the ability of the patient to receive study treatment +Subjects who have an uncontrolled infection +Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1 +Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection. +Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose +Patients with serious, uncontrolled, concurrent infection(s) +Active and uncontrolled infection; patients with an active infection receiving treatment and hemodynamically stable for 48 hours may be entered into the study +Patients with uncontrolled infection are excluded +Active uncontrolled serious infection or sepsis at study enrollment +Serious, 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 cirrhosis +Subject has an active uncontrolled infection. +Co-infection of HBV and HCV +Active and uncontrolled disease (other than AML) or infection as judged by the treating physician +Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month +Active unresolved infection +Patients should not have any uncontrolled illness including ongoing or active infection +Active uncontrolled serious infection or sepsis at study enrollment +Active and uncontrolled disease/infection as judged by the treating physician +Active Infection with HBV or HCV +Active, unresolved infection +Patients with any active, uncontrolled infection are NOT eligible for participation +Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy +Uncontrolled infection +Ongoing or active infection +Active dental infection +Patients who have an uncontrolled infection are not eligible +Uncontrolled active infection +Active 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. +Current 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) +Uncontrolled infection +Active uncontrolled infection +Active life-threatening infection +No ongoing or active infection at study entry +Active serious infection +No previous evidence of opportunistic infection +Presence of uncontrolled infection +No active uncontrolled infection +Patients who have an uncontrolled or untreated infection are not eligible +Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics +Active infection or intercurrent illness +The patient has an uncontrolled infection, or is receiving anti-fungal treatment for an ongoing infection +No 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) therapy +Presence of uncontrolled infection +Presence of uncontrolled infection +Active, uncontrolled systemic infection +Active and uncontrolled disease/infection as judged by the treating physician +Active infection +Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1 +Ongoing or active infection +Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, ongoing immunosuppressive therapy (except for replacement steroids), active human immunodeficiency virus (HIV) infection, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety +Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing +Patients must have an expected survival of > 60 days and must be free of active infection +Uncontrolled infection requiring ongoing antibiotics +Active infection, uncontrolled with intravenous antibiotics +Have ongoing or active infection +Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1 +Presence of uncontrolled infection +No evidence of acute infection +Patients who have uncontrolled active infection +The 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). +Serious active infection or gastrointestinal disease +Active infection\r\n* Active infection includes patients with positive blood cultures +Active/chronic HBV or HCV infection; +Patients must not have untreated or uncontrolled life-threatening infection +Active untreated infection +Active infection at the start of lenalidomide +No untreated or uncontrolled life-threatening infection +Uncontrolled infection +Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy +Active uncontrolled infection +No active infection +Active uncontrolled infection +active urinary tract infection; +Patients must have an expected survival of > 60 days and must be free of active infection +Active infection that is not responding to antimicrobial therapy +Uncontrolled active infection or illness +Patients with uncontrolled infection +Uncontrolled infection +Patients with an uncontrolled life-threatening infection +Patients with an active or uncontrolled infection. +Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics +Subjects with an active uncontrolled infection. +Evidence of ongoing active infection +Other active disease including but not limited to ulceration of the upper gastrointestinal tract, autoimmune disease, HIV infection, active HBV and HCV infection. +Uncontrolled infection +Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or human immunodeficiency virus (HIV) infection +Evidence of an ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the time of start of study therapy +Active major systemic or local uncontrolled infection +Active infection +Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose +Known active uncontrolled systemic infection +Uncontrolled infection +Uncontrolled active infection +Active infection involving IV antibiotics within 2 weeks prior to C1D1 +Active infection involving IV antibiotics within 2 weeks prior to C1D1 +Uncontrolled infection +Any evidence of serious active infection. +Uncontrolled infection +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy +Prior systemic infection with BCG +No evidence of active infection and no serious infection within the past month +Evidence of active infection, or serious infection within the past month +Active and uncontrolled disease/infection as judged by the treating physician +Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. +Active, clinically serious infection greater than CTCAE grade 2. Patients may be eligible upon resolution of the infection. +Patients with uncontrolled infection or systemic disease +Presence of infection other than the infection of the bile duct (cholangitis) +Acute, active infection within 14 days of enrollment +Presence of uncontrolled infection +Uncontrolled opportunistic infection or treatment for opportunistic infection within 4 weeks of first day of study drug dosing +Have a significant uncontrolled infection active infection +The patient has an uncontrolled and active infection that would preclude study conduct and assessment +Presence of uncontrolled infection +Have significant, uncontrolled active infection +Patients with active lung infection or active pulmonary edema +Uncontrolled active infection +Patients with active, uncontrolled infection +Presence of uncontrolled infection. +Active infection within 14 days prior to scheduled treatment +Serious uncontrolled active infection +Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics +Known active meningeal infection +Serious, uncontrolled, concurrent infection(s) +Active uncontrolled infection +Uncontrolled or serious infection +Has an active, uncontrolled infection; +Presence of an active infection or fever >= 38.5 C within 3 days of the first scheduled protocol treatment +Active 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) +Concurrent, acute, active infection, or treatment for infection, other than oral thrush or genital herpes, within 14 days of enrollment +Patients with acute or chronic infection +Active or uncontrolled infection +Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) +Has, at the planned initiation of study drug, an uncontrolled infection. +Active infection +No active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection) +History 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) guidelines +Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months +Patients with active or uncontrolled systemic infection. +Uncontrolled infection within 4 weeks prior to randomization +Ongoing or active infection +Uncontrolled infection +Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy +No active infection +Active infection including cytomegalovirus +Active, uncontrolled infection +Other significant active infection. +Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation +Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV +Active untreated infection +Evidence of ongoing, uncontrolled systemic infection or an uncontrolled local infection requiring therapy at the start of study. +Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection +Active AIDS / HIV infection, clinically uncontrolled immune deficiency disorders; +Active urinary tract infection +Any uncontrolled active systemic infection that requires treatment with intravenous (IV) antibiotics +Active uncontrolled infection +Presence of an infection that requires intravenous antibiotics +Infection:\r\n* Local infection at the puncture site\r\n* Systemic infection, osteomyelitis, discitis +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled +Active infection +Concurrent active infection +Active 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. +Patients with active infection at time of biopsy +Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection. +Infection not controlled by antibiotics +Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation +Subject has an active uncontrolled infection +Active infection not controlled with appropriate antimicrobial therapy +No active infection +Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study drug administration. +Uncontrolled infection or systemic disease. +Other significant active infection. +Presence of uncontrolled infection +Active uncontrolled infection or severe infectious disease +Active uncontrolled infection; +Presence of active, uncontrolled infection. +Active infection. +Active uncontrolled infection or severe infectious disease +Severe or uncontrolled systemic infection +History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection. +Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration. +Active uncontrolled opportunistic infection +Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing +Known active infection. +Infection +Uncontrolled infection +Ongoing infection > grade 2 +Active infection +Patients should not have any clinical evidence of an active infection at the time of enrollment +Active infection, ascites, hepatic encephalopathy +Any active or uncontrolled infection +Treatment with antibiotics for proven infection within 1 week prior to study entry or signs and symptoms consistent with an active infection or fever > 38.1 C. +Known active infection +Evidence of active infection +Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis +Infection +Has uncontrolled infection requiring systematic antibiotics +Presence of uncontrolled infection. +Infection +Have a chronic underlying infection +A serious active infection (> grade 2) within 7 days of enrollment +Serious, uncontrolled, concurrent infection(s) +Presence of active infection +Untreated bladder infection +Ongoing or active infection +Presence of uncontrolled infection +Currently active infection +Documented or suspected infection +Active infection that is not responding to antimicrobial therapy +Active infection +Serious active infection at the time of pre-study screening. +No serious, uncontrolled, concurrent infection(s) +Uncontrolled infection; +Active, uncontrolled infection +Have an uncontrolled infection +An uncontrolled infection +Active infection +Active or uncontrolled infection +Active 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. +Any clinically significant uncontrolled illness including ongoing active infection +Patients who have an uncontrolled infection are not eligible +Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study +Active infection with hepatitis A, B, or C; active infection is defined as serologic positivity and elevated liver function tests +Active infection +Have an active urinary tract infection (UTI), +Any evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent) +Active lung infection +Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. +Ongoing or active infection. +Infection or abscess anywhere in the body +Active infection requiring systemic therapy, known human immunodeficiency virus infection, or positive test for hepatitis B active infection or hepatitis C active infection. +Subjects 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 physician +EXCLUSION - STUDY 1: Active infection +Uncontrolled infection at initiation of protocol treatment +Current vaginal infection +Active and uncontrolled infection at the time of transplantation +Patients with documented infection at time of enrollment +Active Infection +Research participants having any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive 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 cutaneous infection or inflammation +Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection +Patients must not have an active infection +Patients with uncontrolled infection at the time of study entry +Active infection or ulcer at the lumbar injection site +Active clinically significant uncontrolled infection +Serious, uncontrolled, concurrent infection(s) +Active or known prior infection at the pseudarthrosis site +Known active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolved +Any uncontrolled active systemic infection +Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose; active infection with concurrent treatment is acceptable only if the patient is clinically stable +Patient is known to have an uncontrolled active systemic infection +Active clinically significant uncontrolled infection +Active, uncontrolled infection +Active uncontrolled infection +Infection not controlled by antibiotics +Known current vaginal infection +Presence of an uncontrolled infection or infection that required intravenous treatment within 7 days of entry +Active/uncontrolled infection +Active, uncontrolled infection +Uncontrolled infection +Active, uncontrolled infection +Patients should not have any uncontrolled illness including ongoing or active infection +Active infection at time of transplantation (including active infection with aspergillus or other mold within 30 days) +Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. +Presence of an active uncontrolled infection. +Active infection. +Active and uncontrolled infection +Active infection not controlled with appropriate antimicrobial therapy +Evidence of uncontrolled active infection +Active infection not controlled with appropriate antimicrobial therapy +An active infection or with a fever ? 38.5°C +Infection: patients with documented uncontrolled infection at the time of study entry are not eligible +Patient is receiving antibiotic therapy for an active infection +Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI) +Untreated active infection +Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. +Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator. +Active systemic infection or skin infection at or near the acupuncture sites +Infection: Patients who have an uncontrolled infection are not eligible until the infection is judged to be well controlled. +Known 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. +Have 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 +Presence of active infection within 72 hours +Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant +Has an uncontrolled infection on the day of randomization +Clinically active infection; an active infection may alter the biodistribution of 18F-FLT +Uncontrolled infection +Evidence of active infection within 14 days of study enrollment +Ongoing systemic infection +Acute life threatening infection +Patients should not have any uncontrolled illness including ongoing or active infection +Patients should not have any uncontrolled illness including ongoing or active infection +No active skin infection +Patients must not have presence of uncontrolled infection +No concomitant infection or other serious major systemic illness +Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection +Recognized concurrent active infection +Patient must not have an uncontrolled infection +Active infection +Infection 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 control +Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. +Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infection +Any uncontrolled active systemic infection +Active infection +Patients that have recognized concurrent active infection +Active infection or chronic comorbidity that would interfere with therapy +Active infection +Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection +Infection: Subjects with uncontrolled infection not eligible +Active, uncontrolled infection or severe infectious disease. +Active infection +Recent or ongoing serious infection.