Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are not excluded
Subject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy) are allowed provided the subject has a temperature of < 38.3°C within 48 hours of the first dose of study drug.
Uncontrolled intercurrent active infection; controlled infection on long term suppressive or maintenance therapy is permissible
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
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.
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
=< 14 days before first dose of protocol-indicated treatment:\r\n* Anti-cancer therapy with an approved or investigational agent (including chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or biological therapy).\r\n* Radiosurgery or radiotherapy. (Note: A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion.)\r\n* Initiation of a new erythropoietin, darbepoietin, and/or bisphosphonate therapy.\r\n* Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery.)\r\n* Serious or uncontrolled infection.\r\n* Infection requiring parenteral antibiotics. (Note: Patients with a non-serious infection under active treatment and controlled with oral antibiotics initiated at least 10 days prior to initiation of protocol-indicated treatment are not excluded – e.g. urinary tract infection controlled with oral antibiotics.)\r\n* Unexplained fever > 38.0 degree Celsius (C).
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
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)
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
Active, uncontrolled infection; patients with infection controlled with antibiotics are eligible
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
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.
Serious active infection not controlled by antibiotics
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
Subject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy are allowed provided the subject has a temperature of <38.3°C within 48 hours of the first dose of study drug
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Any active infection not controlled by antibiotics
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).
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
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent
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
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
Uncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlled
Serious, active infections must be controlled; patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved
Infection not controlled by antibiotics
Patients with multiple CMV, EBV or adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above; patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll
Active infection not controlled with appropriate antimicrobial therapy
Infection not controlled by antibiotics
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 not controlled with appropriate antimicrobial therapy
Active infection not controlled with appropriate antimicrobial therapy
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.
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.
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
Known active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigator