History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications.
Hx of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids.
Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification
Subject has known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification\r\n* Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study
Patients must not have aspirin sensitive asthma
Other significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participate
Known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] < 50% of predicted normal), persistent asthma, or a history of poorly controlled asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications (subjects with a history of mild asthma that are on or can be switched to noncorticosteroid bronchodilator regimens are eligible)
Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
Severe asthma.
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
History of severe asthma, presently on chronic medications (a history of mild asthma requiring inhaled steroids only is eligible)
Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
History of asthma that is nonsteroidal anti-inflammatory drug (NSAID)-induced or with asthma that is classified as ‘mild-persistent’ or worse (based on symptoms occurring more than 2 days per week)
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible)
Known severe hypersensitivity reactions to monoclonal antibodies (Grade ?3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
Patients with a history of asthma will be excluded
Evidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.
Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
Criteria 6 Known moderate or severe persistent asthma within the past 2 years
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Other significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participate
Subject has known moderate or severe persistent asthma within 2 years, or currently has uncontrolled asthma of any classification; (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. NOTE: subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study
History of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less; note: a history of mild asthma not requiring therapy is eligible
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
Patients with a remote history of asthma or active mild asthma may participate.
Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), known moderate or severe persistent asthma within the last 2 years or currently has uncontrolled asthma of any classification (controlled intermittent asthma or controlled mild persistent asthma is allowed)
Evidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.
History of asthma
Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible)
Moderate to end-stage kidney disease and a history of severe asthma or allergies
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
Participant has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than (<) 50% predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 <50% b) Participant has known moderate or severe persistent asthma within 2 years (see Attachment 4: NHLBI table of asthma severity), or currently has uncontrolled asthma of any classification. (Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
Chronic ongoing oral steroid use at the time of registration for any condition (such as asthma, rheumatoid arthritis, etc)
History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
History of asthma
No history of severe asthma, as defined by prior or current use of systemic corticosteroids for disease control, with the exception of physiological replacement doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less; NOTE: history of mild asthma not requiring daily therapy is eligible
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
Patients must not have uncontrolled asthma
Asthma or other reactive airway disease
History or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
No history of bronchial asthma or related bronchospastic conditions
Prior history of (H/O) severe allergy or asthma requiring active treatment
Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute.
Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute
History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e. asthma) requiring therapy
Adult asthma
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Clinical diagnosis of asthma
Adult asthma
Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute
Asthma, wheezing or breathing problems
History of chronic asthma
Patient must not have a history of allergy or bronchial asthma
Uncontrolled asthma or asthma requiring oral corticosteroids.
Active clinically serious infections or other serious uncontrolled medical conditions
Uncontrolled infections
Active or uncontrolled infections
Active (acute or chronic) or uncontrolled severe infections
Active or uncontrolled infections
Have active (acute or chronic) or uncontrolled severe infections
Uncontrolled active systemic infections
Active or uncontrolled infections
Uncontrolled infections.
No uncontrolled infections;
No uncontrolled infections;
Active uncontrolled acute infections
Active, clinically serious infections or other serious uncontrolled medical conditions
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Uncontrolled infections
Active or uncontrolled infections
Active or uncontrolled infections
No clinically significant uncontrolled infections as determined by investigator
Not have active, uncontrolled infections
Active, uncontrolled infections
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Uncontrolled infections
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Patients with active, uncontrolled infections
Uncontrolled infections; principal investigator (PI) is the final arbiter of this criterion
Active and uncontrolled infections
Patients with untreated or uncontrolled infections
No uncontrolled infections as determined by the investigator
Patients with serious uncontrolled infections will not be eligible
Patients with serious uncontrolled infections at the time of planned transplant will be excluded
Active and uncontrolled systemic infections.
DONOR: Current serious systemic illness including uncontrolled infections
Current uncontrolled infections.
Active clinically serious infections or other serious uncontrolled medical conditions
Uncontrolled infections
Active (acute or chronic) or uncontrolled severe infections.
Active (acute or chronic) or uncontrolled severe infections
Patients with serious uncontrolled infections at the time of transplant will be excluded
Active or uncontrolled infections
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes
Active uncontrolled infections
Active (acute or chronic) or uncontrolled severe infections hepatitis
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Uncontrolled infections
Uncontrolled systemic disease like active infections
DONOR: Current serious systemic illness including uncontrolled infections
Clinically significant uncontrolled illness or active infections
Clinically significant medical conditions including active or uncontrolled infections, new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and uncontrolled diabetes.
Active or uncontrolled infections
Active and uncontrolled infections, including hepatitis B or C
Active (acute or chronic) or uncontrolled severe infections
Severe systemic diseases or active uncontrolled infections
Participants who have active, uncontrolled infections.
Uncontrolled (not being treated) infections at the time of cytoreduction
Uncontrolled infections that are not responsive to antimicrobial therapy
Active serious infections uncontrolled by antibiotics
Active and uncontrolled infections
Patients with uncontrolled infections
Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
Patients with clinically significant history of any chronic liver disease.
Known clinically significant liver disease
Known clinically significant liver disease
Subjects with chronic liver disease or dysfunction
Participants with significant renal or liver disease
Known clinically significant liver disease,
Clinically significant history of liver disease
Known history of chronic liver disease
Participant has a history of liver disease
Known clinically significant liver disease, inherited liver disease and active viral disease
Chronic liver disease
Known clinically significant liver disease
Known clinically significant liver disease
Any known active chronic liver disease
No history of severe prior or ongoing chronic liver disease
Any known active chronic liver disease
Known history of significant liver disease
Known liver disease
No history of severe prior or ongoing chronic liver disease
History of chronic liver disease.
History of chronic liver disease.
History of alcohol abuse or chronic liver disease (other than metastatic disease to the liver)
Has evidence of significant liver disease
Liver disease, except Gilbert's syndrome, liver involvement by CLL or MM, or stable chronic liver disease per investigator's assessment
Liver disease.
Known clinically significant liver disease
Known clinically significant liver disease
Subjects with known history, or clinical or laboratory evidence of liver disease
History of clinically significant liver abnormalities other than liver metastasis
Known active liver disease (cirrhosis, chronic viral hepatitis, autoimmune liver disease or other known clinically significant active liver disease)
History of chronic liver disease.
History of alcohol abuse or chronic liver disease (other than metastatic disease to the liver)
Active chronic liver disease
Known clinically significant liver disease
History of serious liver disease
History of chronic liver disease.
Significant liver disease or metastatic disease to the liver
Known clinically significant liver disease
History of chronic liver disease.
History of chronic liver disease
Clinically significant history of liver disease
Patients with known liver disease
Underlying chronic liver disease with evidence of severe liver impairment.
Known history of chronic liver disease (other than Gilbert’s syndrome)
History of liver disease
Chronic liver disease
Chronic liver disease or in participants without known liver disease, alanine aminotransferase (ALT) >= 3 x normal
History of hepatitis or liver disease
History of, or current, active or chronic liver disease even if transaminases have normalized
Individuals with history of liver disease in last 12 months
History of liver disease within the last 12 months
Severe organ dysfunction unrelated to underlying GVHD, including:
Serum creatinine < 2 mg/dl; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
Have metastatic breast cancer with severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
Major organ system dysfunction including (but not limited to): New York Heart Association class III or IV, pulmonary disease requiring the use of inhaled steroids or bronchodilators, renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction which would impair patient’s ability to participate in the trial
Any subject with a history of significant renal, hepatic, pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac dysfunction
Cardiopulmonary dysfunction
Evidence of renal or liver dysfunction at screening
Prior treatment with clofarabine within 6 months or history of clofarabine-induced liver dysfunction
Have a history of cardiac dysfunction including:
known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
Patients with organ dysfunction
Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as
Liver dysfunction (or digestive involvement with protein loss)
Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI (see Section 10.3.1).
Patients with evidence of synthetic dysfunction or severe cirrhosis requiring deferral of conditioning as recommended by a gastroenterology specialist
No major organ dysfunction precluding transplantation.
Significant cardiopulmonary dysfunction
Acute neurological dysfunction as a result of bone metastasis.
Significant organ dysfunction, not meeting inclusion criteria
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction
Subject has evidence of hepatic dysfunction defined as:
Significant renal, hepatic, or bone marrow organ dysfunction.
No major organ dysfunction precluding transplantation
Subjects must not have evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
No distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes
If organ dysfunction is thought to be related to the HLH process this must be clearly documented in the chart and the patients may be enrolled on study irrespective of creatinine and bilirubin levels
Patients should have no evidence of immune dysfunction as listed below
Significant organ dysfunction defined as:
Patients with systemic infections and/or organ dysfunction mandating a reduced intensity conditioning regimen are also excluded
Patients with renal dysfunction or veno-occlusive disease are eligible
Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patient’s ability to endure known side effects of cytokine release syndrome or neurological toxicity
Hepatic, renal, or bone marrow dysfunction as detailed above
Severe liver dysfunction or pulmonary insufficiency
Severe liver dysfunction or pulmonary insufficiency
Patients with significant renal (creatinine [Cr.] > 1.5 mg/dl or creatinine clearance < 40 cc/min) or hepatic (bilirubin > 2.5 u) dysfunction not due to tumor involvement will not be eligible to receive DA-EPOCH-R chemotherapy
Patient has laboratory estimations indicating organ system dysfunction:
Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
Patients with all degrees of renal dysfunction are allowed including patients on hemodialysis; patients with mild to severe hepatic dysfunction are allowed as defined below:
Patients with both hepatic and renal dysfunction will also be excluded
Patients receiving medications for treatment of left ventricular systolic dysfunction
Organ dysfunction or disease that would jeopardize survival after hematopoietic cell transplantation, including but not limited to the following: \r\n * Renal insufficiency as defined by an estimated glomerular filtration rate (GFR) < 60 mL/minute\r\n * Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction < 50%\r\n * Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pulmonary disease-moderate, using pre-transplant pulmonary function testing per the Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Manual\r\n * Necroinflammatory or fibrotic liver disease with evidence of liver dysfunction, including but not limited to jaundice, hepatic encephalopathy, or portal hypertension\r\n * Marrow dysfunction that poses a risk of peri-transplant mortality, defined as an absolute neutrophil count or lymphocyte count below the lower limit of normal, or a platelet count below 50,000/mm^3\r\n * Poorly controlled hypertension despite appropriate therapy, defined as a diastolic blood pressure greater than 90 mm Hg while on therapy\r\n * Neurologic dysfunction that affects activities of daily living and medical care\r\n * Poorly controlled diabetes mellitus, defined as persistent hyperglycemia despite therapy or recurrent hypoglycemia while on therapy\r\n * Extreme protein-calorie malnutrition defined by body mass index < 18 kg/m^2 and unintentional weight loss (3 kg in the last month or 6 kg in the last 6 months)
Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification
In the opinion of the investigator do not require rapid cytoreduction due to bulky disease (e.g. painful lymphadenopathy or organomegaly, or impending end-organ dysfunction
Patients with normal, mild or moderate hepatic dysfunction are eligible
With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
Patients with significant hepatic dysfunction (not meeting liver function tests [LFT] eligibility criteria)
Patients should have no evidence of immune dysfunction
As patients with steroid refractory acute GvHD are quite ill with multiple abnormal labs and organ dysfunction, there are no explicit laboratory values or degree of organ dysfunction that specifically preclude enrollment on this study; baseline lab studies will be obtained and followed throughout this trial as the standard of care for patients with GvHD
Subject has any other organ dysfunction (CTCAE version 4.03 Grade 4) that will interfere with the administration of the therapy according to this protocol.
Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
Severe organ dysfunction unrelated to underlying GVHD, including:
Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).
EXCLUSION FOR TREATMENT: Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patient’s ability to endure known side effects of cytokine release syndrome or neurologic toxicity
Any other concomitant serious illness or organ system dysfunction as per investigator assessment
Use of erectile dysfunction drugs (e.g., Cialis, Viagra) within 14 days prior to treatment or during study
Cardiovascular dysfunction or Respiratory Failure due to sepsis.
Cardiac disease or dysfunction.
No evidence of significant cardiac or pulmonary dysfunction
Any serious ongoing condition, such as an untreated infection or organ dysfunction
Subjects with severe (immediately life threatening) and recent (occurring within the last 3 months) cardiac dysfunction, pulmonary dysfunction, esophageal variceal bleeding, hemorrhagic strokes, or intracranial hemorrhage are not eligible for study participation
Hepatic dysfunction as evidenced by elevated transaminases
No evidence of significant cardiac or pulmonary dysfunction
Cardiopulmonary dysfunction as defined by protocol
Have a history of liver or renal dysfunction
Significant co-morbidity indicated by major organ system dysfunction
Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
Failure of 2 of the following drugs: interferon-beta1b, interferon beta 1a, and glatiramer acetate; failure is defined by new or progressive physical signs and symptoms that impair activities of daily living; such changes include cognitive decline, vision loss, swallowing dysfunction, limb weakness, limb plasticity, bowel or bladder dysfunction, and coordination or gait dysfunction; these clinical changes should be supported by new or expanding lesions on MRI scanning consistent with disease progression
Creatinine < 2 mg %; patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman
Bilirubin < 2 mg %; patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman
Serious organ dysfunction
Significant hepatic dysfunction, renal dysfunction, or metabolic derangement that precludes full-dose chemotherapy at the specified starting doses
Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
Any organ dysfunction thought to be secondary to disease will be considered separately and the patient will be included at the investigators discretion
History of symptomatic pulmonary dysfunction
Significant cardiac dysfunction:
Known systolic or diastolic dysfunction or heart failure
No evidence of significant cardiac or pulmonary dysfunction
Severe organ dysfunction manifested during screening period:
Laboratory evidence of hepatic dysfunction indicated by any of the following:
Significant organ dysfunction.
Hepatic dysfunction defined as MELD Score > 12.
History of serious cardiac dysfunction
Significant organ dysfunction deemed to be inappropriate for autologous transplantation
Subject has concurrent severe or uncontrolled medical disease or organ system dysfunction which, in the opinion of the Investigators, would limit life expectancy to < 3 months.
Serious myocardial dysfunction defined as ultrasound-determined LVEF < 45% of predicted institutional normal value.
Liver/renal dysfunction
Any medications for treatment of left ventricular systolic dysfunction.
History of significant cardiac dysfunction
Diastolic dysfunction felt to contribute to any clinical sign or symptom.
In hepatic dysfunction group, patients with hepatic dysfunction who have Gilbert's syndrome. Patients signs of encephalopathy (altered brain function).
Evidence of at least 1 new onset organ dysfunction
No specific organ function parameters are required; however, significant abnormalities should be discussed with the study PI (this is especially the case for significant renal dysfunction)
Severe hepatic dysfunction accompanied by coagulopathy definition:\r\n* Known liver disease AND\r\n* International normalized ratio (INR) > 1.5 (except for patients on anticoagulants) AND\r\n* Platelet count < 100,000/uL without other obvious cause
Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis
Hepatic dysfunction (elevated transaminases or bilirubin > 3 times normal), drawn within 28 days of consent
Regarding non-hematologic organ function, no specific criteria for non-hematologic organ function are specified; however, if moderate-to-severe (major) organ function is present, such should be discussed with the PI, as various degrees of non-hematologic organ dysfunction may compromise either (or both) toxicity and response evaluations; also, if there is concern regarding potential reversibility of any specific organ dysfunction, this issue should also be addressed by consultation with an appropriate sub-specialist
Renal dysfunction (creatinine [Cr] > 1.8)
Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis) or neurologic dysfunction will be excluded
Patients unable to use audio media due to auditory dysfunction
Presence of erectile dysfunction symptoms
Patients with severe organ dysfunction\r\n* On dialysis\r\n* Requiring oxygen (O2) at more than 2 l/min\r\n* Uncontrolled arrhythmia or heart failure\r\n* Veno-occlusive disease (sinusoidal obstruction syndrome)
Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
History of known renal dysfunction
Severe organ dysfunction.
Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction)
Have renal dysfunction
History of hepatitis or liver dysfunction
Current or history of hepatic dysfunction
Untreated or uncontrolled cardiovascular disease or other symptomatic cardiac dysfunction
Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction
History of known renal dysfunction
Renal dysfunction for which cisplatin dose would be considered unsafe
Patients with history or evidence of cardiac dysfunction
Sinus node dysfunction
Have a history of liver or renal dysfunction
History of cardiac dysfunction including any of the following:
Any significant acute or chronic medical illness
Other acute or chronic medical or psychiatric condition
Acute or chronic liver or renal disease
Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
Acute or chronic skin and/or microvascular disorders
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
Documented malabsorptive syndromes including enteropathies, gastroenteritis (acute or chronic) or diarrhea (acute or chronic)
Subjects with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Other severe acute or chronic medical condition
Systemic rheumatic or autoimmune diseases or acute or chronic infections
Acute VOC ending 7 days prior to first dosing
Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Be undergoing treatment for acute or chronic hepatitis C.
Acute or chronic pancreatic disease within the last year prior to enrollment
Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
Acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
Any acute or chronic psychiatric problems
Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
Subjects with any acute infection or severe or uncontrolled that requires systematic antibiotic therapy; acute therapy must have been completed at least seven days prior to study enrollment
Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Acute or sub-acute intestinal obstruction
Evidence of active acute or chronic infection
Ongoing acute or chronic inflammatory skin disease.
Chronic immunosuppression
Acute or chronic pancreatic disease
Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
Be undergoing treatment for acute or chronic hepatitis C.
Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
Patients with acute myelofibrosis are excluded
Significant acute or chronic infections
Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic).
Acute or chronic liver, pancreatic or severe renal disease
Ongoing acute or chronic inflammatory skin disease.
Acute or chronic pancreatic disease
Acute or chronic liver or severe renal disease
Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease
Subjects with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
Acute or chronic pancreatic disease
Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
Active (acute or chronic) or uncontrolled severe infection
Acute or chronic liver or pancreatic disease.
Acute or chronic pancreatic disease
Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
Acute or chronic pancreatic disease
Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
No evidence of acute infection
Significant acute or chronic infections, including:
Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
Patients with acute or chronic infection
Ongoing acute or chronic inflammatory skin disease.
Procedures that occur during acute hospitalization.
Acute nephritis
Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
Skin toxicity including but not limited to erythema, rash, ulceration, and open wound that is still clinically present and considered as acute or chronic.
Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
Have a chronic underlying infection
Significant acute or chronic medical illness.
History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease
Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure
Acute suicidal behavior.
Acute medical conditions, such as acute flare-up of joint condition or infection
Acute abdomen
Known chronic aspiration
Chronic immunosuppression
Acute or chronic respiratory disease
Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency
acute respiratory failure,
acute myocarditis or
acute systemic infection and
Acute prostatitis within the last 6 months
Patients suffering from active acute or chronic prostatitis
Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
Symptomatic acute prostatitis
AND with one or more of the following highly prevalent ambulatory-sensitive chronic conditions (diabetes, hypertension, chronic lung disease, chronic kidney disease, depression, or heart disease).
Not in acute crisis
Cirrhosis secondary to any cause will be excluded
History or evidence of cirrhosis
Patients must not have a history of chronic liver disease (or cirrhosis)
Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
History of chronic liver disease or evidence of hepatic cirrhosis
Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (i.e. ascites from cirrhosis requiring diuretics or paracentesis)
Cirrhosis
Patients with documented liver cirrhosis
Has a history of liver disease (including but not limited to cirrhosis).
Liver cirrhosis;
History of cirrhosis
Cirrhosis.
Known cirrhosis or chronic hepatic failure
Liver cirrhosis
High risk for post-embolization hepatic failure:\r\n* Child's C cirrhosis\r\n* > 80% liver involvement by tumor
Liver cirrhosis with greater than grade 1 stage 1 inflammation/fibrosis
Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extra-hepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension
Known cirrhosis
Not have a reported history of liver disease (e.g. cirrhosis)
Individuals with a reported history of liver disease (e.g. cirrhosis)
The patient does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
The patient does not have: \r\n* Cirrhosis at a level of Child-Pugh B (or worse) or\r\n* Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
Liver cirrhosis
Known (and biopsy-confirmed) liver cirrhosis; or, a reported history of liver cirrhosis with a model for end-stage liver disease (MELD) score > 20
Have Child B/C cirrhosis
Liver dysfunction and/ or cirrhosis
Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).
Patients have known chronic liver disease (i.e., cirrhosis)
Liver cirrhosis
Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
Clinical or pathological diagnosis of cirrhosis, hemochromatosis, or hepatic fibrosis
HCV genotype 3 treatment experienced with cirrhosis
Clinical or laboratory evidence of cirrhosis
Patients having:\r\n* Cirrhosis at a level of Child-Pugh B (or worse) or\r\n* Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
Cirrhosis or portal hypertension
biliary cirrhosis
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Chronic liver disease (e.g., cirrhosis)
Patients have known chronic liver disease (i.e., cirrhosis)
Known cirrhosis
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
Other serious medical conditions that may be expected to limit life expectancy to less than 1 year (e.g., liver cirrhosis).
Subjects with liver cirrhosis (as determined by the investigator)
A history of cirrhosis or other chronic liver disease
Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
Cirrhosis of the liver
Patients with liver cirrhosis or any other impaired hepatic function as determined by serum enzymes
Hepatocellular disease (eg, cirrhosis)
Diagnosis of liver cirrhosis
Decompensated cirrhosis
Clinical evidence of cirrhosis
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
Patients with known cirrhosis
Patients with known cirrhosis
Known hepatic cirrhosis
Patients with known cirrhosis.
History of cirrhosis
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
Liver cirrhosis with greater than grade 1 stage 1 inflammation/fibrosis
Patients with liver cirrhosis
Known cirrhosis
Patients with liver cirrhosis (as determined by the investigator)
Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
Participants with a clinical diagnosis of cirrhosis based on the investigator's evaluation, confirmed by any one of following methods to define cirrhosis:\r\n* Established cirrhosis on liver biopsy (Meta-analysis of Histological Data in Viral Hepatitis [METAVIR] F4);\r\n* Computed tomography (CT) or magnetic resonance imaging (MRI) findings consistent with cirrhosis; nodular appearing liver with or without evidence of portal hypertension\r\n* Transient elastography (FibroScan) with a result > 12.5 kPa\r\n* FibroScan score > 0.75 and aspartate aminotransferase (AST) to platelet ratio index (APRI) > 2\r\n* Etiology of cirrhosis will not be considered in determining inclusion in the study
Chronic renal diseases and hepatic cirrhosis
Diagnosis of cirrhosis
Subjects with known hepatic insufficiency or cirrhosis
Subjects with known hepatic insufficiency or cirrhosis
Participants with known hepatic insufficiency or cirrhosis
Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis
Subjects with known hepatic insufficiency or cirrhosis
Documented cirrhosis
Undiagnosed cirrhosis