History of interstitial lung disease.
History of interstitial lung disease
Has a history of interstitial lung disease.
History of interstitial lung disease
Patients with history of interstitial lung disease.
Patient has a known history of chronic interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Has a history of interstitial lung disease related to prior EGFR inhibitor therapy.
Has a history of interstitial lung disease
History of interstitial lung disease.
Has a history of interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
Has interstitial lung disease that has required oral or intravenous glucocorticoids to assist with management.
Subjects with a history of interstitial lung disease
Has a history of interstitial lung disease
Subjects with a history of interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
History of interstitial lung disease
Clinically significant interstitial lung disease
Patient has interstitial lung disease
Symptomatic interstitial lung disease
Persistent proteinuria ? grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Has a known history of interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease
Subjects with a history of interstitial lung disease.
Has a history of interstitial lung disease
Has a history of interstitial lung disease.
History or active interstitial lung disease
Known interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Patient has a known history of chronic interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease
Interstitial lung disease
Clinically significant interstitial pulmonary disease or known diagnosis of interstitial lung disease (ILD)
Patients have history of diagnosed interstitial lung disease
Patients with interstitial lung disease.
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
History of interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
Subjects with a history of symptomatic interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
Has a history of interstitial lung disease.
Interstitial lung disease
Active or prior documented interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Patients with known and confirmed diagnosis of interstitial lung disease (IDL)
Patients with clinically significant interstitial lung disease or history of cardiac disease
Patients with active interstitial lung disease
Patients must not have any known clinically active interstitial lung disease
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease
History of interstitial lung disease
History of interstitial lung disease
Has a history of interstitial lung disease.
History of symptomatic or p previously established interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
History of or active interstitial lung disease
Subjects with a history of interstitial lung disease
History of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Subjects with a history of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
History of or current interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Subjects with clinically significant interstitial lung disease, or obstructive disease without sufficient reserve
History of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of screening
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Interstitial lung disease with ongoing signs and symptoms at the time of screening.
History or concurrent condition of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Has a known history of interstitial lung disease
Has a history of interstitial lung disease
Known interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of study registration.
History of interstitial lung disease.
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Has a history of interstitial lung disease.
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Patients with a history of interstitial
Non-malignant interstitial lung disease;
Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
Interstitial lung disease with ongoing signs and symptoms at the time of screening
Interstitial lung disease with ongoing signs and symptoms at the time of registration
History of interstitial lung disease
Known or suspected history of interstitial lung disease.
History of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
History of interstitial lung disease
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Any serious intercurrent or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol including but not limited to: \r\n* Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL or 7.2 mmol/L)\r\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\r\n* Active infections \r\n* Gastrointestinal disease limiting the ability to swallow oral medications or absorb oral medications including refractory nausea and vomiting, chronic gastrointestinal diseases, inflammatory bowel disease; malabsorption syndromes\r\n* Patients with enteric stomata or significant bowel resection\r\n* Prior history of corneal ulceration\r\n* Patients with any evidence of severe or uncontrolled systemic liver disease including those with known hepatitis B and hepatitis C (excluding treated hepatitis C that has been cured)\r\n* Active bleeding diatheses
Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
Has interstitial lung disease
Has history of interstitial lung disease.
Has active, or a history of, interstitial lung disease.
Known interstitial lung disease.
History of interstitial lung disease (Parts D and E only).
Restrictive or obstructive pulmonary disease
History of clinically severe lung disease, asthma, or chronic obstructive pulmonary disease (COPD) requiring emergency management and/or hospitalization in the last year
Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
Severe chronic obstructive pulmonary disease (COPD) defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months
Pulmonary: no requirement for supplemental oxygen and no evidence of moderate-severe chronic obstructive pulmonary disease (COPD) by pulmonary function tests (PFTs)
Uncontrolled medical conditions including diabetes, heart failure, chronic obstructive pulmonary disease (COPD), ulcerative colitis, or Crohn’s disease
If they have New York Heart Association (NYHA) class 3 or 4: myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or places the patient at undue risk for treatment related complications
Forced expiratory volume in 1 second (FEV1) >= 2.0 liters or >= 75% of predicted for height and age; (pulmonary function tests (PFTs) are required for patients over 50 or with significant pulmonary or smoking history defined as > 20 pack years or history of chronic obstructive pulmonary disease [COPD]/emphysema)
Pulmonary disease which, in the opinion of the investigator, may impair the patient's respiratory tolerance to moderate pulmonary fluid overload (e.g., interstitial lung disease, severe chronic obstructive pulmonary disease)
New York Heart Association class 3 or 4 heart failure; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis, or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEPHB4-HSA or places the patient at undue risk for treatment related complications
Uncontrolled chronic obstructive pulmonary disease or previous known pulmonary fibrosis
Chronic medical illness including diabetes with the use of insulin, hemoglobin A1c > 7 (study physician discretion), heart disease diagnosed by angiogram, chronic obstructive pulmonary disease (COPD) diagnosed by pulmonary function testing and requiring an oxygen supply
History of clinically significant chronic obstructive pulmonary disease (COPD), asthma, or other chronic lung disease.
Known severe chronic obstructive pulmonary disease or asthma
Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis
Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary fibrosis
Patients who have major medical problems such as severe cardiac, pulmonary (COPD requiring constant oxygen), or non-healing ulceration.
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function test (PFT)’s indicating an forced expiratory volume in 1 second (FEV1) less than 50% or a carbon monoxide diffusing capability test (DLCO) less than 40% predicted for age\r\n* Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease will undergo pulmonary function testing and will not be eligible if their FEV1 is < 50% of expected
Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary fibrosis
Patients with pre-existing uncontrolled pulmonary disease will be excluded; uncontrolled refers to patients having had at least one hospitalization due to pulmonary disease (for example, asthma, chronic obstructive pulmonary disease) within the 6 months prior to enrollment in the study; patients with previous history of pneumonitis will be excluded
Has known history of, or any evidence of active, non-infectious pneumonitis that required steroids (steroid treatment of chronic obstructive pulmonary disease [COPD] or asthma allowed)
Has New York Heart Association (NYHA) class 3 or 4, myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or pembrolizumab (MK-3475) or places the patient at undue risk for treatment related complications
Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, chronic obstructive pulmonary disease [COPD])
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function tests (PFTs) indicating a forced expiratory volume in one second (FEV1) less than 50% or a diffusion capacity of carbon monoxide (DLCO) less than 40% predicted for age
Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease
Serious medical conditions (congestive heart failure [CHF], angina, diabetes mellitus type 1, chronic obstructive pulmonary disease [COPD], bleeding diathesis)
Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 < 50% of predicted normal
Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis; this does not include obstruction from tumor
If they have New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the patient at undue risk for treatment related complications
Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary disease requiring systemic steroid therapy, oxygen, or hospitalization
Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary fibrosis
Severe chronic obstructive pulmonary disease (COPD) requiring > 3 hospitalizations in the past year
History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1] < 60% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction
History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume [FEV] > 60% of predicted for height and age required in patients with prolonged smoking history or symptoms of respiratory dysfunction)
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume of the lung in 1 second [FEV1] > 60% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with prolonged smoking history or signs, symptoms, or history of respiratory dysfunction)
Patients who require chronic oxygen therapy for chronic obstructive pulmonary disease or pleural effusions (malignant or benign)
History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume in one second [FEV1] > 60% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction
Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function tests (PFTs) indicating an forced expiratory volume in 1 second (FEV1) less than 50% or a diffusion capacity of the lung for carbon monoxide (DLCO) less than 40% predicted for age; Note: patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is < 50% of expected
Clinically significant lung disease including known history or evidence of interstitial lung disease or chronic obstructive pulmonary disease (COPD) that requires oxygen therapy
Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. COPD requiring chronic oral steroid therapy
Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, chronic obstructive pulmonary disease [COPD], allergic rhinitis)
Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
Inflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.
History of other pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume in 1 second [FEV1] < 60% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction
Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, chronic obstructive pulmonary disease [COPD])
Subjects with a history of interstitial lung disease or lung disease that has required intubation in the past (i.e. such as asthma or chronic obstructive pulmonary disease [COPD]); patients requiring continuous supplemental oxygen are excluded
Any history of symptomatic pulmonary compromise, such as chronic obstructive pulmonary disease
Patients with significant impairment of pulmonary function on account of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume in one second (FEV1) to less than 75% of predicted normal values
Concurrent major medical conditions, such as uncontrolled hypertension, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, autoimmune disease, adrenal insufficiency, or prior allogeneic organ transplant requiring chronic immunosuppressive therapy, including systemic glucocorticoid treatment or replacement therapy
Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
Concomitant corticosteroid use for systemic or topical treatment of skin disease is not allowed except a dose of steroid of no more than 20 mg of prednisone or its equivalence is allowed for asthma, chronic obstructive pulmonary disease (COPD), or inflammatory bowel disease (IBD); stable use of topical corticosteroids of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4) and tumor stage (T3) with intense pruritus
Severe chronic obstructive or other pulmonary disease with hypoxemia
Evidence of chronic obstructive pulmonary disease
Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume in one second (FEV1) to less than 75% of predicted normal values
Participants with diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months, or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the participant at undue risk for treatment related complications
Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, chronic obstructive pulmonary disease [COPD])
Asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication.
Inflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.
Patients with severe cardiac disease including symptomatic congestive heart failure, unstable angina, or have experience an acute myocardial infarction within the past 6 months; please note: patients with chronic obstructive pulmonary disease (COPD) are not excluded
History of other pulmonary disease such as emphysema or chronic obstructive pulmonary disease, (forced expiratory volume in one second [FEV1] < 60% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction
Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, pulmonary fibrosis, and pulmonary arterial hypotension.
Chronic steroid or immunosuppressive therapy (except for low dose corticosteroids for chronic obstructive pulmonary disease [COPD] or topical steroids, which are allowed)
Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis
No history of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD), (forced expiratory volume in one second [FEV1] > 2L or >= 50% of predicted for height and age); pulmonary function tests (PFTs) are required in patients with significant pulmonary or smoking history
Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including recent myocardial infarction (within 6 months)or stroke; hypertension requiring >2 medications for adequate control; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring >2 hospitalizations in the preceding 12 months.
Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment.
Severe chronic obstructive pulmonary disease (COPD) by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging system
Subjects on supplemental oxygen or history of chronic obstructive pulmonary disease (COPD)
Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST
Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplemental oxygen
Active or symptomatic cardiopulmonary disease (myocardial infarction < 1 month, heart failure >= New York Heart Association [NYHA] II, atrial fibrillation with poor rate control, high grade atrioventricular [AV] block, obstructive valvular disease, chronic obstructive pulmonary disease [COPD])
Other causes of cachexia such as: liver disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 x normal levels); renal failure (creatinine > 1.5 mg/dL), untreated thyroid disease, class III-IV congestive heart failure (CHF), acquired immune deficiency syndrome (AIDS), other cancer diagnosed within the past 5 years other than non-melanoma skin cancer, severe chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2)
History of severe chronic obstructive pulmonary disease (COPD) and resting oxygen saturation (SpO2) < 90%
Chronic obstructive pulmonary disease (COPD)
Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment
Diagnosed with chronic obstructive pulmonary disease (COPD) oxygen dependent
Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
Has a serious cardiopulmonary medical condition (including cardiovascular disease, congestive heart failure [CHF], chronic obstructive pulmonary disease [COPD], restrictive lung disease, interstitial lung disease, asthma, acute or chronic bronchitis, cystic fibrosis, pneumonia, tuberculosis, pneumoconiosis, pulmonary hypertension, pulmonary embolism, pleural effusion, pneumothorax, obesity hyperventilation syndrome, neuromuscular lung disease)
Known history of chronic pulmonary disease
Physician-diagnosed chronic obstructive pulmonary disease (COPD)
Severe obstructive lung disease (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage III or IV, FEV1 < 30% predicted)
Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD] requiring oxygen)
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD])
Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
Pre-existing respiratory conditions:\r\n* Severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema)\r\n* Other respiratory or lung conditions, which would place the participant at risk\r\n* Presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea
Patients must have pulmonary function as defined below:\r\n* Abnormal pulmonary function test within 3 months of study entry\r\n* Prior radiation to the lungs\r\n* Prior surgical resection of lung tissue (i.e. wedge resection, lobectomy, or pneumonectomy)\r\n* Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema\r\n* Ongoing oxygen use
Immune system disorders, pulmonary diseases (e.g., asthma within the prior 5 years, acute bronchitis within 1 year, chronic obstructive pulmonary disease [COPD], chronic bronchitis, and restrictive lung disease), clinically diagnosed kidney or liver diseases, or any other medical disorders that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use; all subjects are screened by a pulmonologist obtaining a medical history and a physical examination (heart, lungs and oral cavity) to ensure no increased risk from bronchoscopy or e-cig use
recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus
pre-existing clinically significant dysfunction of the heart or Chronic Obstructive Pulmonary Disease (COPD)
Patients may not have a known or confirmed history of pneumonitis
Evidence of current pneumonitis
Participants with evidence of pneumonitis on scans at screening will be excluded
Patients excluded with any prior treatment of pneumonitis requiring corticosteroids.
Pneumonitis and history of pneumonitis.
History of pneumonitis
History and/or confirmed pneumonitis
Patient is confirmed to have actively symptomatic pneumonitis
Patients with a history of pneumonitis
History of pneumonitis
History of pneumonitis within the last 5 years
History of pneumonitis within the last 5 years
History of pneumonitis
Prior history of radiation pneumonitis
Known prior history of interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention)
History of pneumonitis or active lung infection
History of pneumonitis
A history of drug-induced pneumonitis or hypersensitivity pneumonitis from prior ALK TKI therapy
Pneumonitis within the last 5 years
History of or ongoing drug-induced pneumonitis
Patients with active pneumonitis TREATMENT SCREENING:
Active pneumonitis
Active or prior history of pneumonitis that required corticosteroids
Has known history of, or any evidence of active, non-infectious pneumonitis; history of radiation pneumonitis is allowed provided that it is not active and no corticosteroids were required for pneumonitis management
Patients with active sepsis or pneumonitis
Known history or ongoing diagnosis of pneumonitis
Patient has documented pneumonitis which is active and requiring treatment
History of acute pneumonitis.
Presence of active pneumonitis
Pneumonitis that requires oral or IV steroids;
Current pneumonitis or history of pneumonitis requiring steroids
Ongoing drug-induced pneumonitis
Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
Participant has history of interstitial lung disease (ILD) OR a history of pneumonitis that has required oral or IV steroids. Participants whose pneumonitis was solely as a result of radiation therapy for their NSCLC would not be excluded from the study unless they received oral/IV steroids to manage the pneumonitis.
Subjects with pneumonitis or at risk of pneumonitis;
History of drug-induced pneumonitis
Ongoing drug-induced pneumonitis
History of pneumonitis attributed to an EGFR inhibitor; history of radiation pneumonitis is allowed provided steroid administration for pneumonitis was not required
Ongoing active pneumonitis
Ongoing drug-induced pneumonitis
History of pneumonitis within the last 5 years
Diagnosis of diffuse radiation pneumonitis
History of pneumonitis
Subject has a history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
Participants with a history of interstitial lung disease (ILD) / pneumonitis
Patients with any evidence of current interstitial lung disease (ILD) or pneumonitis
Has evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring oral or intravenous glucocorticoids
History of pneumonitis or interstitial lung disease (ILD).
Active interstitial lung disease (ILD)/pneumonitis or a prior history of ILD/pneumonitis requiring treatment with steroids.
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring oral or IV glucocorticoids
Patient with active interstitial lung disease (ILD)/pneumonitis or a prior history of ILD/pneumonitis requiring treatment with steroids
History and/or confirmed interstitial lung disease (ILD)/pneumonitis, extensive bilateral lung disease on high-resolution computed tomography (HRCT) scan
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Past history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
History of interstitial lung disease (ILD)/pneumonitis requiring treatment with steroids and patients with active ILD/pneumonitis
Evidence of clinically active interstitial lung disease (ILD) and/or history of ILD
History of drug-induced interstitial lung disease (ILD), ILD, or radiation pneumonitis requiring treatment with steroid prior to study enrollment, or any evidence of clinically active ILD.
Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
Past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
History of interstitial lung disease (ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computed tomography (CT) or magnetic resonance imaging (MRI)
History of interstitial lung disease (ILD)
History of interstitial lung disease (ILD)
History of interstitial lung disease (ILD)
Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
History of interstitial lung disease (ILD).
Severely impaired lung function
History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function
History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function
History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function
History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
Severely impaired lung function
History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
Severely impaired lung function
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
Patients with interstitial lung disease and/or pneumonitis are not eligible
Patients must not have symptomatic interstitial lung disease or pneumonitis
Patients must not have a history of pneumonitis or interstitial lung disease
Patients must not have evidence of interstitial lung disease or pneumonitis
Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis
Subjects with a history of interstitial lung disease and/or pneumonitis
History of interstitial lung disease or chronic pneumonitis
Participants with current pneumonitis or interstitial lung disease
Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
History of pneumonitis or other interstitial lung disease
Has active pneumonitis requiring treatment with steroids or active interstitial lung disease
Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded.
History of or active pneumonitis or interstitial lung disease:\r\n* For history of pneumonitis to be an exclusion, patient had to have required supplemental oxygen or corticosteroid treatment; radiographic changes alone are not an exclusion
Patients with history of interstitial lung disease or pneumonitis.
History of pneumonitis or interstitial lung disease.
History of interstitial lung disease or pneumonitis.
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Currently active pneumonitis or interstitial lung disease.
History of interstitial lung disease, pneumonitis or other clinically significant lung diseases.
History of interstitial lung disease or pneumonitis that has required steroid administration
History of adrenal insufficiency, pneumonitis, interstitial lung disease, or inflammatory bowel disease
History of interstitial pneumonitis
History of pneumonitis or interstitial lung disease
Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
Current or history of interstitial pneumonitis,
History of interstitial lung disease and/or pneumonitis
History of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
Patients with active interstitial lung disease and non-infectious pneumonitis or a history of active interstitial lung disease or pneumonitis requiring treatment with steroids or that may interfere with the detection or management of suspected drug-related pulmonary toxicity. Patients with lung cancer with a remote history of pneumonitis following chemo-radiation treatment that has resolved are allowed.\r\n* Note: Patients with chronic obstructive pulmonary disease (COPD) whose disease is controlled (per investigator judgment) at trial entry are not excluded.
Subjects with active interstitial pneumonitis.
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). (Note, this does NOT include immune-mediated pneumonitis)
Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis/pneumonia or pulmonary pathology that is not well controlled in the opinion of the treating physician and/or principal investigator (PI).
Participants with clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and patients with history of clinically significant interstitial lung disease or radiation pneumonitis
History of medically diagnosed pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis.
History of interstitial lung disease or pneumonitis
History of pneumonitis or drug-related inflammatory lung disease
Patients with a history of interstitial lung disease or pneumonitis
History of pneumonitis or interstitial lung disease
History or clinically confirmed pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis
History or the presence of pulmonary interstitial disease, or drug-related pneumonitis
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
Active or prior documented history of pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis
Has a history of interstitial lung disease or pneumonitis from any cause
Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis/pneumonia or pulmonary pathology that is not well controlled in the opinion of the treating physician and/or principal investigator (PI)
History of interstitial lung disease or pneumonitis
Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; lymphangitic spread of the NSCLC is not exclusionary
History of pneumonitis or interstitial lung disease
Patients with a history of pneumonitis or interstitial lung disease
Has known history of/active pneumonitis requiring treatment with steroids or history of/active interstitial lung disease
Has a history of interstitial lung disease or pneumonitis.
History of interstitial lung disease or pneumonitis
History of interstitial lung disease/pneumonitis
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis that is uncontrolled in the opinion of the treating physician
Interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Currently have or have a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.
History of treatment-related interstitial lung disease/pneumonitis
Evidence of interstitial lung disease or active pneumonitis
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis
History of interstitial lung disease and/or immune mediated pneumonitis
History of interstitial lung disease or pneumonitis
Patients with known history of interstitial lung disease or idiopathic pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Subjects with any history of interstitial lung disease or a history of > or = to grade 2 radiation pneumonitis
Interstitial lung disease or pneumonitis not secondary to ECD
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Patients with a history of interstitial lung disease or pneumonitis
Patient must not have a history of interstitial lung disease or pneumonitis
CLINICAL/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis
Patients with a history of interstitial lung disease or pneumonitis
Subject has a history of pneumonitis or interstitial lung disease. Hepatocellular Carcinoma Exclusion Criterion:
Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management.
Subject has interstitial lung disease or a history of pneumonitis
Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded, however, subjects cannot be oxygen dependent).
Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
Current or history of pneumonitis or interstitial lung disease
Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis that is uncontrolled in the opinion of the treating physician
Presence or history of interstitial lung disease or interstitial pneumonitis
Interstitial lung disease or pneumonitis that has required oral or IV steroids
History of interstitial lung disease or unresolved pneumonitis
Has history of interstitial lung disease or pneumonitis.
Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
History of or current drug-induced interstitial lung disease or pneumonitis grade ?2
History of interstitial lung disease or unresolved pneumonitis
History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events.
Patients with active interstitial pneumonitis
History of pneumonitis or interstitial lung disease.
Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
Have a history or the presence of pulmonary interstitial disease or drug-related pneumonitis.
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Presence of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis
Subjects with a history of pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis
Confirmed pneumonitis or interstitial lung disease
A history of clinically significant interstitial lung disease or pneumonitis
History and/or confirmed pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis
Presence of interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
History of interstitial lung disease/pneumonitis from any cause
History of interstitial pneumonitis
History of interstitial pneumonitis
Patients with interstitial pneumonitis
History of interstitial lung disease or pneumonitis of any cause
Has a history of, active pneumonitis requiring treatment with steroids or history of/active interstitial lung disease
Known preexisting interstitial lung disease or pneumonitis
History of interstitial lung disease or pneumonitis.
History of interstitial lung disease or pneumonitis
Active pneumonitis or interstitial lung disease
History of interstitial lung disease or pneumonitis.
Known interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded, however, subjects must not be oxygen dependent).
History of interstitial lung disease or pneumonitis
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
History of interstitial lung disease or pneumonitis
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
Have history of interstitial lung disease or pneumonitis.
Known history or confirmation of active pneumonia, pneumonitis, symptomatic interstitial lung disease, or definitive evidence of interstitial lung disease described on CT scan, MRI, or chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen therapy.
Patients with evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
Evidence of interstitial lung disease
History or any evidence of interstitial lung disease;
Participants must not have evidence of interstitial lung disease
Presence of cavitation of central pulmonary lesion, or radiographic evidence of pneumonitis or other extensive bilateral lung disease such as interstitial lung disease
Evidence of interstitial lung disease
Has evidence of interstitial lung disease
Has evidence of interstitial lung disease
Evidence of interstitial lung disease
Has evidence of interstitial lung disease
Evidence of interstitial lung disease
History of, or evidence of clinically active, interstitial lung disease
Has evidence or a history of interstitial lung disease
Has evidence of interstitial lung disease
Has evidence of interstitial lung disease
Has evidence of interstitial lung disease
Has evidence of interstitial lung disease
Patient has evidence of interstitial lung disease
Evidence of interstitial lung disease
Evidence of interstitial lung disease
Known history of active pneumonia, pneumonitis, symptomatic interstitial lung disease, or definitive evidence of interstitial lung disease described on CT scan, MRI, or chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen therapy.
Evidence of interstitial lung disease
Evidence of interstitial lung disease
Evidence of interstitial lung disease
Symptomatic interstitial lung disease or definitive evidence of interstitial lung disease described on CT scan, MRI, or chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen.
Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
Evidence of interstitial lung disease
Has evidence of interstitial lung disease
Other clinically severe or uncontrolled systemic illness or any concurrent condition that in the view of the principal investigator could compromise the participant’s ability to tolerate vandetanib or could compromise study procedures or endpoints, including interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
Any evidence of clinically active interstitial lung disease
Symptomatic interstitial lung disease or definitive evidence of interstitial lung disease described on CT scan, MRI, or chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen therapy.
Patients with evidence of interstitial lung disease
Known history of, or any evidence of, interstitial lung disease
Any evidence of clinically significant interstitial lung disease
Subject has history of drug-induced interstitial lung disease or any evidence of active interstitial lung disease.
Evidence of interstitial lung disease.
Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
Uncontrolled cardiac disease
Patient with recent cardiac history (within 6 months) of:
Symptomatic cardiac disease
Have a serious cardiac condition.
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
Participant has active cardiac disease or a history of cardiac dysfunction including any of the following:
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement
history of or current cardiac issues
EXCLUSION - TREATMENT: Cardiac criteria: prolonged QT syndrome; atrial fibrillation/flutter; myocardial infarction within the last 12 months; cardiac echocardiography with LVSF ? 30% or LVEF ? 50%; cardiac dysfunction NYHA III or IV; cardiac echocardiography with clinically significant pericardial effusion
History of arrhythmia requiring an implantable cardiac defibrillator
Subject is undergoing one of the following open elective cardiac, general, or urological surgical procedures: Cardiac procedure (Epicardium); Cardiac procedure (aortic anastomosis or aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
Subject is undergoing one of the following elective procedures: Cardiac procedure (Epicardium); Cardiac procedure (Aortic Anastomosis or Aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
Any cardiac finding that is deemed ineligible at the discretion of the investigator
No presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
Cardiac failure, class I-IV
Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function
Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease
Have a serious cardiac condition.
Resting QTcF ?470 msec at pretreatment (baseline) or other cardiac or cardiac repolarization abnormality
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement
Patients with known cardiac shunts
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
Any history of clinically significant cardiac arrhythmia, coronary revascularization, ischemic symptoms, or previously documented left ventricular ejection fraction (LVEF) of less than or equal to 45%; a cardiac stress test is required for all patients greater than 50 years old; a cardiac stress test may also be performed for any clinical concern; patients with cardiac ischemia are not eligible
Congestive cardiac failure of >Grade II severity according to the NYHA;
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
History of arrhythmia requiring an implantable cardiac defibrillator.
History or presence of heart failure or left ventricular dysfunction with ejection fraction < 40% within the previous 6 months; if >6 months cardiac function within normal limits and free of cardiac-related symptoms
Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
Serious cardiac condition within the last 6 months
Donor must not have any medical condition which would make apheresis more than a minimal risk, and should have the following: \r\n* Family members will be considered for donation if they do not have a history of known cardiac problem and do not have abnormal cardiac findings by physical examination; those with a history of cardiac problems or abnormal cardiac findings by physical examination should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
Have cardiac pacemakers
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
Patients requiring anti-arrhythmia cardiac medications are NOT eligible
No symptoms of uncontrolled cardiac disease
History of cardiac disease, in particular, supraventricular tachycardia
Active heart (cardiac) disease as defined in the protocol
Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
No active co-morbid cardiac condition such as active CHF or CAD
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 20%)
Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
Cardiac or cardiac repolarization abnormality
Cardiac MRI T2* <10ms;
Patients with unstable cardiac status including:
Normal/negative cardiac stress testing with myocardial perfusion imaging OR cardiac catheterization with non-significant angiogram findings reviewed by a cardiology consultant (dose level 3 and >= 40 years old)
Patients with intra-cardiac defibrillators
Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia
Normal cardiac function; patients who have a history of heart disease, or who are over the age of 50 years must have a normal cardiac stress test within the prior 90 days
Subjects with significant cardiac issues
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 27%)
History of arrhythmia requiring an implantable cardiac defibrillator
Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 28%) NOT due to mediastinal mass
Cardiac arrhythmia requiring maintenance medication
Patients must not have serious and inadequately controlled cardiac arrhythmia
Serious cardiac arrhythmia requiring medication
Cardiac arrhythmia not controlled with medical management
Cardiac involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram greater than 12 mm in the absence of other potential causes of left ventricular hypertrophy (controlled hypertension is allowed) with a noncardiac biopsy showing amyloid, or a positive cardiac biopsy in the presence of clinical or laboratory evidence of involvement. If there is isolated cardiac involvement, then typing of amyloid deposits is recommended.
History or current evidence of cardiac arrhythmia and/or conduction abnormality
Significant active cardiac disease within the previous 6 months from the signing of the ICD, including:
Cardiac:
Cardiac Troponin I within normal limit.
History of arrhythmia requiring an implantable cardiac defibrillator;
Abnormal cardiac status
History or evidence of cardiac disease as indicated by any of the following:
Serious and inadequately controlled cardiac arrhythmia
Patient has active cardiac disease or a history of cardiac dysfunction
Patients with a known history of cardiac disease. This includes:
Known cardiac metastases
A functional cardiac test (e.g., stress treadmill, stress thallium, multigated acquisition scan (MUGA), dobutamine echocardiogram) to rule out cardiac ischemia within 4 months prior to lymphodepletion is required for all patients
Known cardiac metastases
Have abnormal cardiac findings.
Cardiac arrhythmia
Cardiac disease
Active cardiac disease
Significant active cardiovascular or pulmonary disease at study entry ? History of arrhythmia requiring an implantable cardiac defibrillator
Any of the following cardiac diseases currently or within the last 6 months:
DONOR: Donors must not have any medical condition which would make apheresis more than a minimal risk, and should have the following:\r\n* Family members will be considered for donation if they do not have a history of known cardiac problem and do not have abnormal cardiac findings by physical examination; those with a history of cardiac problems or abnormal cardiac findings by physical examination should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate\r\n* Bilirubin and hepatic transaminases =< 2.5 x upper limit or normal (ULN)\r\n* Adequate hematologic parameters including a hematocrit > 35% for males and 33% for females, white blood cell count of >= 3,000, and platelets >= 80,000\r\n* Foundation for the Accreditation of Cellular Therapy (FACT) laboratories (labs) must be drawn within 7 days of collection and final test results available prior to infusion into the patient; in the case of multiple donations from the donor, the FACT labs must be redrawn within 7 days of each initiation of apheresis (positive serologies are not repeated as they remain positive for lifetime but all other donor labs are performed)
Cardiac troponin I or cardiac troponin T levels above the limit of normal as specified by the manufacturer.
Presence of cardiac metastases
Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
History of any of the following cardiac conditions:\r\n* Angina requiring treatment with long-acting nitrates\r\n* Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration\r\n* Unstable angina within 90 days of visit 1\r\n* Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
T2*MRI cardiac evaluation with T2* >= 20 milliseconds
Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
Active cardiac disease, defined as (but not limited to):
Cardiac dysrhythmias;
Patients with cardiac atrial or cardiac ventricular lymphoma involvement
Cardiac involvement
Evidence of significant cardiac disease, for example: symptomatic cardiac heart failure (CHF, NYHA class 3), complete bundle branch block, significant atrial or ventricular tachyarrhythmias and any unstable cardiac arrhythmias requiring medication.
Left ventricular ejection fraction < 30%; Note: poor cardiac function predicts for cardiac morbidity, not cardiac mortality; therefore, a cardiology consultant may override the criteria for eligibility
Ongoing cardiac dysrhythmias
History or evidence of cardiac risk.
History of cardiac disease
Active cardiac disease or a history of cardiac dysfunction.
serious cardiac arrhythmia.
Known cardiac disease which precludes their ability to receive planned treatments:\r\n * Angina pectoris that requires the use of anti-anginal medication\r\n * History of documented congestive heart failure\r\n * Serious cardiac arrhythmia requiring medication\r\n * Severe conduction abnormality\r\n * Valvular disease with documented cardiac function compromise; and\r\n * Uncontrolled hypertension defined as blood pressure (BP) that is consistently > 150/90 on antihypertensive therapy at the time of registration; (patients with hypertension that is well controlled on medication are eligible)
Cardiac involvement
Types of cardiac operations permitted:
Patients with history of cardiac dysrhythmia
Patient's with any metallic cardiac implant
Any of the following cardiac criteria: CHF > Class II, cardiac ventricular arrhythmia requiring therapy, unstable angina or new-onset angina, QTcF interval >470ms, abnormal ECHO or MUGA at baseline (LVEF <50%).
History of cardiac disease
Patients with intra-cardiac defibrillators
Abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (ECHO)
Subjects with intra-cardiac defibrillators or permanent pacemakers
History or evidence of cardiac risk
Known cardiac/cardiopulmonary disease
History of cardiac disease
Known cardiac/cardiopulmonary disease
Cardiac exclusions:
Patients with intra-cardiac defibrillators
Serious and inadequately controlled cardiac arrhythmia
Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
Major cardiac disease
Has cardiac status as described in protocol
Patients with intra-cardiac defibrillators or permanent pacemakers.
Cardiac metastases
Abnormal cardiac stress testing within last 6 months
Active cardiac disease;
Current or uncontrolled cardiac disease
Patients with unstable cardiac status including:
Have a serious cardiac condition
Cardiac pacemakers
Patients with any known significant cardiac abnormality.
No known cardiac history (i.e., heart failure, myocardial infarction, or radiation-induced cardiac dysfunction)
Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrhythmia, or severe cardiomyopathy
Unstable cardiac condition
Known cardiac shunt
Patients with known cardiac shunt
Subject has any form of known cardiac arrhythmia
Cardiac disease (cardiac viability assessment)
Patients with cardiac shunts or congenital heart defects
Patient must not have serious and inadequately controlled cardiac arrhythmia
Patients with cardiac shunts
Patients with cardiac shunts
Patients with cardiac shunts
Known or suspected: cardiac shunts
History of cardiac arrhythmia requiring treatment
History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
Cardiac troponin (cTn) levels above the upper limit of normal
Abnormal cardiac status with any of the following:
Known, clinically important cardiac or respiratory disease
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Has evidence of active, noninfectious pneumonitis that requires treatment with steroids
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
History of (noninfectious) pneumonitis that require steroids or current pneumonitis
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Evidence of interstitial lung disease or noninfectious pneumonitis.
Has evidence of active, noninfectious pneumonitis that required treatment with steroids
Has known history of or any evidence of active, noninfectious pneumonitis
Known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis
History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
Patients who have evidence of active, noninfectious pneumonitis or have a history of severe pneumonitis that required treatment with steroids are not eligible for this study
Has known history of, or any evidence of active, noninfectious pneumonitis
Patients with a history of noninfectious pneumonitis will be excluded during the dose-escalation phase of the trial
Patient has history of interstitial lung disease or known history of, or any evidence of active, noninfectious pneumonitis
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
DOSE ESCALATION COHORT: Evidence of or any history of interstitial lung disease or active, noninfectious pneumonitis including symptomatic and/or pneumonitis requiring treatment
DOSE EXPANSION COHORT: Evidence of or any history of interstitial lung disease or active, noninfectious pneumonitis including symptomatic and/or pneumonitis requiring treatment
Evidence of interstitial lung disease or active, noninfectious pneumonitis
Has evidence of noninfectious pneumonitis that required steroids or current pneumonitis.
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
Has evidence or history of interstitial lung disease or active noninfectious pneumonitis
Evidence of active noninfectious pneumonitis or history of interstitial lung disease.
Patients who have evidence of active, noninfectious pneumonitis or have a history of severe pneumonitis that required treatment with steroids are not eligible for this study; (Note: replacement physiologic dose of steroids [prednisone 10 mg daily or equivalent] are allowed)
History of (noninfectious) pneumonitis that required steroids or current pneumonitis
Patients with interstitial lung disease or active, noninfectious pneumonitis
History of noninfectious pneumonitis
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
History or evidence of active, noninfectious pneumonitis that required treatment with steroids
EXCLUSION CRITERIA FOR CROSSOVER THERAPY: History or evidence of active, noninfectious pneumonitis that required treatment with steroids
Known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
Patients must not have a history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, noninfectious pneumonitis