Chronic myelomonocytic leukemia or myelodysplastic/myeloproliferative neoplasm (unacceptable MDS subtypes); uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement) at time of enrollment.
REGISTRATION STEP 2-RANDOMIZATION: Patients must not have active infection (systemic bacterial, fungal, or viral infection) that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active and clinically significant bacterial, fungal, or viral infection
Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
Patients must not have a systemic bacterial, fungal, or viral infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
Patients with active bacterial or fungal infections unresponsive to medical therapy
Known active bacterial, viral, fungal, mycobacterial, or other infection
Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757
Active and clinically significant bacterial, fungal, or viral infection
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks prior to first infusion
Active and clinically significant bacterial, fungal, or viral infection
Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
Active bacterial or systemic viral or fungal infections
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Known active infections (bacterial, fungal, viral including HIV positivity).
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C.
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
COHORT 1: Has an active uncontrolled infection requiring systemic therapy (viral, bacterial or fungal); patients with infection under active treatment and controlled with antibiotics are eligible
COHORT 2: Has an active uncontrolled infection requiring systemic therapy (viral, bacterial or fungal); patients with infection under active treatment and controlled with antibiotics are eligible
Symptomatic/active bacterial, or fungal, or any other opportunistic infection
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with human immunodeficiency virus (HIV), or an active infection with hepatitis B or hepatitis C.
Uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment.
Known uncontrolled fungal, bacterial, and/or viral infection ?Grade 2.
Active bacterial, fungal or viral infection
Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.
Active bacterial, viral, or fungal infection requiring systemic therapy.
Uncontrolled viral, bacterial, or fungal infections (human immunodeficiency virus [HIV] infection permitted if viral load undetectable)
Active bacterial, fungal, or viral infection requiring systemic treatment; patients who are receiving treatment for infections that are under control may be included in this study
Uncontrolled systemic fungal, bacterial, viral, or other serious infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment); may be enrolled if controlled on treatment
Systemic fungal, bacterial, viral or other infection that is not controlled.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Current active, uncontrolled bacterial, viral, or fungal infection
Active bacterial or viral infection
Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
Evidence of an ongoing systemic bacterial, fungal, or viral infection.
Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
Active and clinically significant bacterial, fungal or viral infection\r\n* Known infections with hepatitis B (HBV) or hepatitis C (HCV)\r\n* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness not controlled (with undetectable viral load) on highly active antiretroviral therapy (HAART) therapy; patients on HAART with undetectable viral loads may be eligible per principal investigator (PI) judgment
Uncontrolled bacterial, fungal, or viral infections including HIV - chronic asymptomatic viral hepatitis is allowed
Participants with active viral, bacterial or fungal infection requiring concurrent antiviral or antibiotics
Active >= grade 3 viral, bacterial, or fungal infection within 2 weeks prior to day 1 of protocol therapy
Presence of a systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Active bacterial, fungal, or viral infection
Any clinically significant infection defined as any acute viral, bacterial, or fungal infection that requires specific treatment. NOTE: Anti-infective treatment must be completed ? 7 days prior to study registration.
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to registration. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to registration.
Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
Uncontrolled bacterial, viral, or fungal infection at the time of enrollment. Uncontrolled is defined as currently taking medication and with progression or no clinical improvement on adequate medical treatment.
PROCUREMENT EXCLUSION: Active bacterial fungal or viral infection
TREATMENT EXCLUSION: Active bacterial, viral or fungal infection
Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV)
Active and uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with human immunodeficiency virus (HIV), or an active infection with hepatitis B or hepatitis C.
Systemic fungal, bacterial, viral or other infection that is not controlled
Participants receiving antibiotic therapy for treatment of a bacterial infection or bacterial prophylaxis upon admission for allogeneic HSCT; use of any agent (e.g. sulfamethoxazole/trimethoprim) for prophylaxis of pneumocystis jirovecii pneumonia is permitted; concurrent use of anti-fungal and anti-viral therapies is also permitted
HIV or active bacterial, viral or fungal infections
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings); the principal investigator is the final arbiter of this criterion
Active, uncontrolled bacterial, viral, fungal, or other opportunistic infection requiring systemic therapy.
Active invasive fungal infection requiring treatment with anti-fungal medication
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active uncontrolled acute fungal, bacterial, or other infection that is unresponsive to therapy at time of study drug dosing
Subjects with active or uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal), diagnosis of fever and neutropenia within 1 week prior to first dose of study drug.
Active systemic viral, bacterial or fungal infection requiring treatment
Have an active fungal, bacterial, and/or known viral infection
Uncontrolled viral or bacterial infection at the time of study enrollment
AUTOLOGOUS APHERESIS: Severe intercurrent bacterial, viral or fungal infection
TREATMENT WITH SJCAR19: Severe, uncontrolled bacterial, viral or fungal infection
Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy
Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or during day 0 (within 24 hrs of CAR T infusion)
Having any uncontrolled illness including ongoing or active bacterial, viral or fungal infection
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1
Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)
Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of study therapy. Note: Subjects with localized fungal infections of skin or nails are not precluded from participation.
Any known clinically significant active infection including bacterial, fungal or viral including hepatitis B (HBV), hepatitis C (HCV) or any underlying disease or in the recent past which could compromise enrollment and safety of the patient.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.
Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
The participant has an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
Active bacterial, fungal or viral infection.
The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis
Infection Criteria\r\n* Positive blood culture within 48 hours of study enrollment\r\n* Fever above 38.2 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* Active fungal, viral, bacterial, or protozoal infection requiring IV treatment; chronic prophylaxis therapy to prevent infections is allowed
Uncontrolled bacterial infection
Uncontrolled bacterial, viral or fungal infection in the 6 week before enrollment
Known uncontrolled fungal, bacterial, and/or viral infection ?Grade 2
Have an active fungal, bacterial and/or known viral infection including human immunodeficiency virus or viral (A, B, or C) hepatitis (screening is not required).
Uncontrolled active infection (bacterial, fungal, viral, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents
Absence of uncontrolled active infection (bacterial, fungal, viral, mycobacterial) not responding to treatment with antibiotics, antiviral agents, or antifungal agents
Active viral, bacterial, or fungal infection progressing on current treatment
Active bacterial or fungal infections unresponsive to medical therapy
Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy
Uncontrolled and active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Active bacterial, fungal or viral infection not controlled by adequate treatment, at enrollment.
have any clinically significant infection, defined as any acute viral, bacterial, or fungal infection that requires systemic treatment or have received any anti-infective treatment within 7 days prior to the screening visit;
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1
Active bacterial, fungal or viral infection not controlled by adequate treatment, at enrollment
Active bacterial or viral infections requiring systemic therapy
Current uncontrolled bacterial, fungal or viral infections (defined as currently taking medication and having continuing clinical symptoms or radiologic findings)
Uncontrolled active infections (viral, bacterial, and fungal)
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1
Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible
Uncontrolled bacterial, fungal or viral infections including human immunodeficiency virus (HIV)-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management. Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Uncontrolled bacterial, fungal or viral infections including human immunodeficiency virus (HIV)-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute (NCI)-CTCAE version 4.03 grade > 2
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1
Participants with a history of an opportunistic fungal infection or active fungal infection requiring, or at high risk of requiring, prophylactic or treatment with fluconazole, voriconazole or posaconazole
Uncontrolled systemic fungal, bacterial, viral, or other infection
Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible; known hypersensitivity to any study drug
Active bacterial, viral, or fungal infections, requiring systemic therapy apart from anti-viral maintenance therapy for HIV.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Acute bacterial or fungal infection requiring intravenous antibiotics within 7 days of enrollment;
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy
Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of study therapy. Note: Subjects with localized fungal infections of skin or nails are eligible.
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24-48 hours
Active bacterial, fungal or viral infection
Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible
Uncontrolled bacterial, viral, or fungal infection at the time of enrollment; uncontrolled is defined as currently taking medication and with progression or no clinical improvement on adequate medical treatment
Active >= grade 3 (per NCI CTCAE v4) viral, bacterial, or fungal infection within 2 weeks prior to initiation of study treatment
Does not have current uncontrolled bacterial, fungal, or viral infection
Patients with uncontrolled bacterial, viral or fungal infections
Uncontrolled active systemic infection (viral, bacterial, and fungal)
Active bacterial, fungal or viral infections unresponsive to medical therapy
Acute bacterial, viral, or fungal infection requiring treatment at the time of registration
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24-48 hours prior to study day 0, unless fever is thought to be secondary to the underlying hematologic disease
Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
EXCLUSION CRITERIA FOR TNBC: Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
Active uncontrolled systemic fungal, bacterial or viral infection
Patient has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment;
Uncontrolled active systemic infection (viral, bacterial, and fungal)
Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV) , requiring treatment with intravenous (IV) antibiotic, IV anti-fungal, or anti-viral; (testing is not required for eligibility)
Uncontrolled viral, fungal, or bacterial infection
CERITINIB EXCLUSION CRITERIA: Known active infection (bacterial, fungal, viral including human immunodeficiency virus [HIV] positivity)
REGORAFENIB EXCLUSION CRITERIA: Known active infection (bacterial, fungal, viral); viral infection includes known HIV positivity, or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
ENTRECTINIB EXCLUSION CRITERIA: Known active infection (bacterial, fungal, viral including HIV positivity)
Active systemic fungal, bacterial, viral or other infection, unless disease is under treatment with antimicrobials and considered controlled in the opinion of the investigator
Patient with uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs/symptoms despite appropriate treatment
Active uncontrolled bacterial, viral or fungal infections
Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
Active serious systemic disease, including active bacterial or fungal infection
Patients with systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment
Active viral, fungal, bacterial or other infection
Active fungal infection or bacterial sepsis
Severe, active comorbidity, defined as follows:\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Active Crohn’s disease or ulcerative colitis\r\n* Scleroderma
Patients should not have any uncontrolled illness including ongoing or active bacterial, viral or fungal infection
Uncontrolled active infections (viral, bacterial, and fungal); the study chair will be the final arbiter of this criterion
Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms
Patients must not have an uncontrolled bacterial, fungal or viral infection, defined as progressive symptoms despite therapy, at the time of the CD8+ memory T-cell infusion; asymptomatic viremia is allowed
Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible
Patients with documented active bacterial, viral or fungal infection, untreated systematic peptic ulcer disease, uncontrolled diabetes mellitus or serious concurrent medical disease that could limit survival to less than 3 months
Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) seropositive status
Patients with uncontrolled active infections (viral, bacterial, or fungal) are not eligible
PART 1: Uncontrolled viral, bacterial, or fungal infections at the time of study enrollment
PART 2: Uncontrolled viral or bacterial infection at the time of study enrollment
Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
Patients with active uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms)
Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to starting the conditioning regimen
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 4 weeks prior to the start of cycle 1; patients with suspected active or latent tuberculosis (latent tuberculosis needs to be confirmed by positive interferon-gamma release assay)
An uncontrolled bacterial, viral, or fungal infection or an active duodenal ulcer, until these conditions are corrected or controlled.
Uncontrolled bacterial or viral infections, or known HIV, hepatitis B or C infection
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Does not have current uncontrolled bacterial, fungal, or viral infection
Uncontrolled viral, bacterial, or fungal infections
Known mixed invasive mold fungal infection including Zygomycetes, and/or a known invasive Aspergillus fungal infection in which either study drug may not be considered active.
Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled
Patients with active viral, bacterial or systemic fungal infection requiring treatment.
Active uncontrolled bacterial, viral or fungal infections
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Active bacterial, viral or fungal infections
Uncontrolled bacterial, viral or fungal infections.
Uncontrolled viral, bacterial or fungal infection
Patients with active uncontrolled life threatening infection (s) from viral, bacterial, fungal or other organisms will be excluded; patients with human immunodeficiency virus (HIV) infection will be excluded
Uncontrolled bacterial, mycobacterial, or fungal infection
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C
Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study
Active ongoing viral, bacterial, or fungal infection
Active viral, bacterial or fungal infection unless adequately treated; for fungal infection, patient should have completed full course of antifungal therapy with resolution of infection
Active viral, bacterial or fungal infection
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
Uncontrolled viral or bacterial infection at the time of study enrollment
Uncontrolled viral or bacterial infection at the time of study enrollment
Active bacterial infection within one week of HCT
Active fungal infection at time of HCT
Active fungal, bacterial, and/or viral infection.
Have active, bacterial, viral, or fungal infections, requiring systemic therapy
Other serious uncontrolled conditions such as fungal, bacterial or viral infection; HIV, Hepatitis B or C, bleeding disorders, interstitial lung disease,
Patients with active or uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Clinically significant active viral, bacterial or fungal infection requiring:
Uncontrolled bacterial, fungal or viral infections including human immunodeficiency virus (HIV)-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
Patients with uncontrolled bacterial, viral or fungal infections including diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of transplant)
Patients with known NCI CTCAE Grade 3 or higher (requiring IV antibiotics) active systemic or cutaneous viral, bacterial, or fungal infection.
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
Active systemic viral, bacterial or fungal infections requiring treatment.
Active systemic fungal, bacterial, and/or viral infection.
Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis.
Any active viral, bacterial, or systemic fungal infection within 4 weeks prior study entry
Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) ( Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at Screening and/or Cycle 1 Day 1 (predose))
216 Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of first dose AMG 562. NOTE: Simple UTI and uncomplicated bacterial pharyngitis are permitted after consultation with sponsor and if responding to active treatment.
Active, uncontrolled urogenital bacterial, viral or fungal infections, including urinary tract infection (UTI). Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
Acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed at least 7 days prior to study treatment.
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials, and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. known chronic viral hepatitis, human immunodeficiency virus (HIV)]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24 hours; patients with fever thought to be likely secondary to leukemia are eligible
Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management\r\n* Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Uncontrolled viral or bacterial infection at the time of study enrollment
Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
Clinically significant active viral, bacterial or fungal infection
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
Evidence of active viral, bacterial, or systemic fungal infection.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1
Uncontrolled bacterial, viral or fungal infection defined as currently taking antimicrobial therapy and progression of clinical symptoms
Patients with a systemic fungal, bacterial, viral, or other infection not controlled
Active bacterial or fungal infection; all prior infections must be resolved following optimal therapy
Active bacterial, viral, or fungal infection
Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the principal investigator)
No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms)
Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
Current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the Investigator, would preclude the patient from exposure to a biologic agent or pose a risk to patient safety
Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
Subject has an uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
Has an invasive fungal infection.
active bacterial, fungal infection, or detectable viral infection
Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ? 72 hours prior to infusion)
Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
Uncontrolled acute life threatening bacterial, viral or fungal infection
Known active infections (bacterial, fungal, viral including HIV positivity).
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
Uncontrolled systemic fungal, bacterial, or viral infection
Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment), uncontrolled hypertension, cardiac arrhythmia, pneumonitis, interstitial lung disease, active peptic ulcer disease or gastritis that would limit compliance with study requirement.
Active bacterial, viral, or fungal infection requiring systemic treatment at the time of study entry.
Have active bacterial, fungal, and/or known viral infection.
Current or recent history (< 21 days prior to start of treatment) of a clinically significant bacterial, viral, fungal, parasitic or mycobacterial infection
Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active bacterial infection
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Active bacterial, viral, fungal, or other infection
Active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Patients with active bacterial or fungal infections unresponsive to medical therapy
Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
Progressive or persistent viral or bacterial infection
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Active bacterial infection
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24 hours; patients with fever thought to be likely secondary to leukemia are eligible
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Patients with a history of active systemic fungal infection.
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms)
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration or within 2 weeks of cycle 1 day 1.
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, herpes zoster, and HIV, but excluding fungal infections of nail beds
Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.
Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1
Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible
Has any clinically significant infection, i.e., any acute viral, bacterial, or fungal infection that requires specific treatment (anti-infective treatment has to be completed ? 7 days prior to study entry).
The participant has a known active fungal, bacterial, or viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Active, uncontrolled bacterial, viral, or fungal infections.
Any clinically significant infection defined as any acute viral, bacterial, or fungal infection that requires specific treatment. NOTE: Anti-infective treatment must be completed ? 7 days prior to study registration.
Participants with active bacterial, viral, or fungal infection requiring systemic treatment
Participant exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection requiring IV therapy (viral, bacterial or fungal).
Any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease
Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus (HIV)
Have active bacterial or fungal infection, or detectable viral infection
Have an active infection of any kind (fungal, viral, or bacterial)
Other clinically significant uncontrolled condition(s) including, but not limited to, systemic infection (viral, bacterial or fungal)
Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) ? Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at randomization
Active and clinically significant bacterial, fungal, or viral infection
Systemic fungal, bacterial, viral, or other infection that is not controlled
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1
Active bacterial or systemic viral or fungal infections.
Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
Uncontrolled bacterial, viral or fungal infection
Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal), diagnosis of fever and neutropenia within 1 week prior to first dose of study drug
Active viral, bacterial or fungal infection
Uncontrolled bacterial, viral or fungal infections (i.e., currently taking medications with progression of clinical symptoms or signs)
Patients with a systemic fungal, bacterial, viral, or other infection not controlled despite appropriate antibiotics or other treatment; uncontrolled systemic infections require infectious disease consultation for verification
Uncontrolled viral or bacterial infection at the time of study enrollment
Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration.
Uncontrolled viral, bacteria or fungal infection at time of study enrollment
Subjects with acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy; acute therapy must have been completed more than 14 days prior to study treatment
Active viral, bacterial or fungal infection
Serious non-malignant disease (e.g., active uncontrolled bacterial, viral, or fungal infections) or other medical conditions (including psychiatric) which, in the opinion of the Principal Investigator (PI) would compromise other protocol objectives
Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active bacterial, viral or fungal infections
Any active systemic viral, bacterial, or fungal infection requiring IV treatment with antimicrobial therapy within 1 week prior to first dose
Systemic fungal, bacterial, viral, or other infection if not controlled; defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment (may be enrolled if controlled on treatment)
Active bacterial or viral infection
Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement).
Uncontrolled bacterial or viral infections - chronic asymptomatic viral hepatitis is allowed
Uncontrolled bacterial, fungal or viral infections including human immunodeficiency virus (HIV) - chronic asymptomatic viral hepatitis is allowed
No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
Active bacterial or fungal infections unresponsive to medical therapy
Active fungal, bacterial, and/or viral infection
Active viral, bacterial or fungal infection
Uncontrolled systemic bacterial, fungal or viral infection
The participant has active bacterial infection, fungal infection, or detectable viral infection or viral load.
Active bacterial, fungal or viral infections requiring treatment with intravenous (IV) antibiotic, IV antifungal, or IV anti-viral drugs
Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Patients with other conditions not related to leukemic relapse (e.g. veno-occlusive disease or uncontrolled bacterial, viral or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T cell infusion
Active bacterial or fungal infections unresponsive to medical therapy
Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection of which they exhibit ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment; the patient needs to be off all pressor medications and have negative blood cultures for at least 48 hours
Currently known uncontrolled bacterial, viral, fungal, HIV, hepatitis B, or hepatitis C infection
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Active infections (bacterial, fungal, or viral)
Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails).
Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
Fungal or viral infection requiring additional therapy
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Have an active, known fungal, bacterial, and/or known viral infection.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Current uncontrolled bacterial, viral or fungal infection.
Infections\r\n* ARM A: Without active uncontrolled bacterial, fungal or viral infection\r\n** Cytomegalovirus (CMV)- If CMV viremia is < 137 IU/ml, but patients are on therapy for CMV\r\n** Human herpes virus (HHV)-6 < 40,000 copies/ML and without active trend up\r\n* ARM B: No limitation
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy at time of screening.
Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Have an active infection of any kind (fungal, viral, or bacterial)
Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as requiring IV antimicrobial, antifungal or antiviral agents)
Active and clinically significant bacterial, fungal, or viral infection
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ? 7 days prior to administration of study medication
Active bacterial, fungal or viral infection.
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study enrollment
Have an active, known fungal, bacterial, and/or known viral infection.
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, HTL, positive serology for HCV or HBV (acute or chronic infection based on CDC guidelines)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease but excluding fungal infections of the nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
Have a known active fungal, bacterial, and/or known viral infection. Hepatocellular cancer participants with chronic viral (B or C) hepatitis are eligible if they retain adequate liver function.
Active uncontrolled bacterial, viral or fungal infections.
Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Uncontrolled bacterial, viral, or fungal infections
Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible)
Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
Evidence of uncontrolled systemic bacterial, fungal, or viral infection at the start of study drug
Active viral, bacterial or fungal infection requiring intravenous treatment with antimicrobial therapy starting less than four weeks prior to first dose.
Evidence of ongoing systemic bacterial, fungal, or viral infection. Known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
Subject has serious/active bacterial, viral or fungal infection requiring systemic treatment.
Active bacterial, viral, or fungal infection
Subject has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Does not have current uncontrolled bacterial, fungal, or viral infection
Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
Patient has a current uncontrolled bacterial, fungal, or viral infection per the judgment of the principal investigator (PI)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
Patients with uncontrolled active infections (viral, bacterial, and fungal) are not eligible
Active and clinically significant bacterial, fungal or viral infection
Known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required).;
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
Patients with active fungal, viral, or bacterial infections
History of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 14 days
Active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible)
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24 hours; patients with fever thought to be likely secondary to leukemia are eligible
Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection, within 7 days of study entry requiring systemic therapy
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
Active uncontrolled bacteria, fungal or viral infection
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Does not have current uncontrolled bacterial, fungal, or viral infection per the judgment of the principal investigator (PI)
Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to the first dose of study drug (routine antimicrobial prophylaxis is acceptable)
Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy < 7 days prior to administration of study medication
Known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required)
Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Participant with a systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement), despite appropriate antibiotics or other treatment)
Active bacterial infection
Uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
Any history of recent serious bacterial, viral, fungal, or other opportunistic infections, precluding a stem cell transplant according to the treating physician
Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible
Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
Active uncontrolled bacterial or invasive fungal infections
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
Evidence of any viral, bacterial, or fungal infection involving the lung and not responding to appropriate treatment
Active infection (symptomatic bacterial and fungal infection – newly diagnosed and/or requiring treatment)
Patients with a documented active infection prior to starting their preparative regimen; this includes grade 3 or higher viral, bacterial, or fungal infection
Patients with a documented active infection prior to starting their preparative regimen; this includes grade 3 or higher viral, bacterial, or fungal infection
Patients with a documented active infection prior to starting their preparative regimen; this includes grade 3 or higher viral, bacterial, or fungal infection
Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion
Uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment
Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Active, uncontrolled urogenital bacterial, viral or fungal infections, including urinary tract infection that in the opinion of the investigator, contraindicates participation. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
Uncontrolled bacterial, viral or fungal infections
Current active tuberculosis or systemic fungal infection
Specifically diagnosed and uncontrolled fungal, bacterial, viral, or other infection (e.g. confirmed sepsis, pneumonia, abscess, cellulitis, etc.) at the day chemotherapy is initiated. \Uncontrolled\ is defined as exhibiting ongoing signs and symptoms of infection without improvement despite antimicrobial or other treatment.
Uncontrolled bacterial, viral infection or invasive fungal infection
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
Patients with uncontrolled bacterial, viral or final infections (currently taking medication ad with progression or no clinical improvement) at time of enrollment
Active bacterial, viral, fungal infection not controlled with appropriate antimicrobial therapy
No uncontrolled bacterial, viral or fungal infection at time of enrollment defined as currently taking medication and progression of clinical symptoms
Subjects who are being treated for fungal, viral, or bacterial pneumonia
Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection
Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
Uncontrolled bacterial, viral or fungal infection at the time of leukapheresis, lymphodepleting chemotherapy or JCAR017 infusion
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of study drug administration or oral antibiotics within 14 days prior to study drug administration.
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management.
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
Subject has an uncontrolled infection. If a bacterial or viral infection is present, the subject must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the subject must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
Invasive bacterial infection
Subjects with active fungal, viral, or bacterial infections.
Active serious systemic disease, including active bacterial or fungal infection within 2 weeks before study entry
Have an active fungal, bacterial, and/or known viral infection, including human immunodeficiency virus (HIV) or viral (B or C) hepatitis.
Evidence of any serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
Uncontrolled systemic fungal, bacterial or viral infection at time of enrollment (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment).
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
Evidence of any active, uncontrolled bacterial, viral, parasitic fungal infections within 1 week of first dose of study drug