Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
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:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;\r\n** History of documented congestive heart failure (CHF); or\r\n** Documented cardiomyopathy
Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)\r\n* Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any grade II/III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; patients with a history of atrial fibrillation must have atrial fibrillation controlled for at least 30 days prior to registration
No cardiac arrhythmias within 182 days of registration
There are no minimal organ function requirements for enrollment on this study\r\n* Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment
Impaired cardiac function or clinically significant cardiac disease.
History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
Impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Shortening fraction of >= 27% by echocardiogram (while not receiving medications for cardiac function), or
Impaired cardiac function
Any of the following cardiac conditions:
Impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac disease
Current evidence of cardiac ischemia
Uncontrolled cardiac disease
- Patient presenting with cardiac disorders defined by at least one of the following conditions:
Patient with recent cardiac history (within 6 months) of:
Symptomatic cardiac disease
Cardiac ejection fraction < 30% (or, if unable to obtain ejection fraction, shortening fraction < 26%) on multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (echo), symptomatic coronary artery disease, or other cardiac failure requiring therapy; patients with a history of, or current cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consult; patients with a shortening fraction of < 26% must be seen by cardiology for approval
Uncontrolled cardiac arrhythmia (subjects with rate-controlled atrial fibrillation are not excluded).
Have a serious cardiac condition.
Subject has any neuropathy > Grade 1. 5. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
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
Any subject with a history of significant renal, hepatic, pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac dysfunction
history of or current cardiac issues
Have experienced any of the following within the 6-month period prior to Screening: unstable angina pectoris, clinically significant coronary artery disease, cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia
EXCLUSION - PROCUREMENT: Cardiac criteria: prolonged QT syndrome; atrial fibrillation/flutter; myocardial infarction within the last 12 months; cardiac echocardiography with left ventricular systolic function (LVSF) ? 30% or left ventricular ejection fraction (LVEF) ? 50%; cardiac dysfunction New York Heart Association (NYHA) III or IV; cardiac echocardiography with clinically significant pericardial effusion
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
Adequate Cardiac Function defined as shortening fraction of >=27% by echocardiogram (while not receiving medications for cardiac function), or ejection fraction of >= 50% by gated radionuclide study (while not receiving medications for cardiac function), the corrected QTc interval by Bazett's formula (QTcB) <450 milliseconds (msec), and must not have a history of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.
History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
EXCLUSION CRITERIA FOR REGISTRATION: History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
Any history of CTCAE grade ?2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
Clinically significant cardiac disease or impaired cardiac function
History of arrhythmia requiring an implantable cardiac defibrillator
Any of the following cardiac criteria:
Adequate cardiac left ventricular function
Having clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic CHF
Have a history of cardiac dysfunction including:
Impaired cardiac function or clinically significant cardiac disease.
Any of the following cardiac criteria:
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
Impaired cardiac function or clinically significant cardiac disease.
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.
History of cardiac or aortic surgery,
Medical suitability for resection, including documented medical and cardiac clearance
Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Any cardiac finding that is deemed ineligible at the discretion of the investigator
Cardiac: Shortening fraction >= 28%
Known cardiac arrhythmias requiring medication.
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than one year prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous cardiac disease will be required to have a negative or low probability cardiac stress test for cardiac ischemia
No presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
Cardiac failure, class I-IV
Any of the following cardiac criteria:
Significant cardiac abnormalities
Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function
Have a significant cardiac condition.
Current significant cardiac conduction abnormalities and hypokalemia as specified in the protocol.
Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
Have a serious cardiac condition.
Resting QTcF ?470 msec at pretreatment (baseline) or other cardiac or cardiac repolarization abnormality
Impaired cardiac function.
Has cardiac pathology, defined as:
Unstable angina pectoris or cardiac ventricular arrhythmia.
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
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n*Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device.
Cardiac stress test within past 6 months without evidence of reversible ischemia
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients with electrocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new significant rhythm, axis or ST segment changes will be included; if clinically significant, new EKG changes are present, patients may be included if cardiac stress test indicates no reversible cardiac ischemia
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
History of the following cardiac conditions:
Congestive cardiac failure of >Grade II severity according to the NYHA;
Impaired cardiac function
Absence of uncontrolled cardiac arrhythmia
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
Free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia; the ejection fraction by gated cardiac blood flow scan (MUGA) or echocardiogram must be > 40%
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen; this includes but is not confined to: \r\n* Active cardiac diseases including: \r\n** Symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention\r\n** Ventricular arrhythmias except for benign premature ventricular contractions\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n** Conduction abnormality requiring a pacemaker\r\n** Valvular disease with documented compromise in cardiac function\r\n** Symptomatic pericarditis \r\n* History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function\r\n** History of documented congestive heart failure (CHF) \r\n** Documented cardiomyopathy
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
History/presence of arrhythmia (even controlled) on chemical anti-arrhythmic(s) must have cardiac consult to ensure the subject could safely proceed with protocol requirements
History of arrhythmia requiring an implantable cardiac defibrillator.
Current cardiac arrhythmia requiring concurrent use of anti-arrhythmic drugs
Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past 6 months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI])
Electrocardiogram without evidence of acute cardiac ischemia
Symptomatic atrial fibrillation or other cardiac arrhythmia for which the therapy is not stable or requiring changes in therapy within 1 month of treatment initiation; atrial fibrillation or other cardiac arrhythmia which is clinically stable on stable therapy is allowed
Cardiac disease that would preclude administration of the drugs included in the study treatment regimen including, but not limited to:\r\n* Angina pectoris that requires the current use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
Any of the following cardiac criteria:
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Certain cardiac abnormalities or history
Left ventricular ejection fraction >= 45%, assessed within 3 months prior to registration, e.g. by multigated acquisition scan (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographic suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
Light chain (AL) amyloidosis patients with Mayo cardiac stage III (defined as N-terminal proB-type natriuretic peptide measurement [proBNP] > 332 ng/L and cardiac troponin [cTnT] > 0.035 ug/L)
Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death
The patient has cardiac conditions defined per protocol
Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy are not eligible
Patients who have a history of significant cardiac disease, cardiac disease risk factors or uncontrolled arrhythmias are NOT eligible for either Stratum
Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia
Heart conditions - any of the following:\r\n* Any atrial fibrillation =< 3 months prior to registration\r\n* Unstable angina =< 12 months prior to registration\r\n* Prior symptomatic congestive heart failure\r\n* Documented myocardial infarction =< 6 months prior to registration (pretreatment electrocardiogram [ECG] evidence of infarct only will not exclude patients)\r\n* Prior significant ventricular arrhythmia requiring medication\r\n* Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay =< 6 months prior to registration\r\n* Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease =< 12 months prior to registration\r\n* NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease; these conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias; it is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo
The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness
History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease
cardiac conditions, including
Patients who are greater than age 50, or who have a history of coronary artery disease, will be required to undergo cardiac stress testing within 6 months of screening and will be excluded if there is evidence of reversible ischemia
Impaired cardiac function or clinically significant cardiac diseases
No uncontrolled arrhythmias or symptomatic cardiac disease
For patients designated to be treated on Group 2: cardiac ejection fraction >= 35%; for patients with significant risk factors for coronary artery disease (Framingham risk score > 15%), a cardiac stress test is recommended
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Participants with impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or history of cardiac problems
Unstable/inadequate cardiac function:
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Any of the following cardiac criteria:
Active or unstable cardiac disease or heart attack within 3 months of starting study treatment
Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
Cardiac function suitable for protocol-required hydration as determined by the investigator and/or cardiologist
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
History of heart failure or cardiac arrhythmia
No uncontrolled arrhythmias or symptomatic cardiac disease
A stress cardiac test (stress thallium, stress multi-gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 1 month of lymphodepletion
History of cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within past 3 months
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
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function
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
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
Active cardiac disease: symptomatic angina pectoris within the past 90 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
Adequate cardiac function defined as no history of clinically significant arrhythmia, or history of myocardial infarction (MI) within 3 months prior to study enrollment; cardiac function will be assessed by history and physical examination
Patient must have normal cardiac function documented by ejection fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation or fractional shortening ( > 27%) documented by echocardiogram and EKG must demonstrate no abnormality severe enough to justify cardiac medications and baseline QTc interval less than or equal to 450 msecs
Patients requiring anti-arrhythmia cardiac medications are NOT eligible
History of any cardiac events including coronary revascularization or ischemic symptoms
Not requiring pressor support, not having symptomatic cardiac arrhythmias
Not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
Cardiovascular criteria: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
No symptoms of uncontrolled cardiac disease
Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography.
History of any cardiac events including coronary revascularization or ischemic symptoms
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
History of cardiac disease, in particular, supraventricular tachycardia
A stress cardiac test (stress thallium, stress multigated acquisition [MUGA] scan, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
Active heart (cardiac) disease as defined in the protocol
Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
Cardiac pacemaker.
No active co-morbid cardiac condition such as active CHF or CAD
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Symptomatic atrial fibrillation, or other symptomatic cardiac arrhythmia
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 20%)
Patient with history of cardiac arrest within the past 6 months
Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 50% by echocardiogram
Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible)
Significant cardiac abnormalities;
Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
Any of the following cardiac conditions:
Any of the following cardiac criteria:
> Class II Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Cardiac or cardiac repolarization abnormality
Patients who have impaired cardiac function or clinically significant cardiac diseases,
Myocardial infarction, cardiac arrest or cardiac failure within 1 year before screening/baseline visit;
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Patients with unstable cardiac status including:
Patient presenting with at least one of the following feature: ischemic heart disease, cardiac failure, conduction disorders or arrythmia
Impaired cardiac function or history of cardiac problems
Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.
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:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or\r\n** Documented cardiomyopathy
Cardiac conditions per protocol
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)
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) > 40% documented by echocardiogram (ECHO).
Significant cardiovascular abnormalities including any one of the following: Congestive heart failure, Clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy; or patients with a history of cardiovascular disease. (Patients with the above will undergo a cardiac evaluation which can include a stress test and/or echocardiography. Results of this evaluation will be considered before excluding patients on the basis of cardiovascular abnormalities). Subjects with evidence of stress-induced cardiac ischemia or ejection fraction less than 55% will be excluded.
Patients with intra-cardiac defibrillators
Cardiac arrhythmias
Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia
Participant has active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medications\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Impaired cardiac function or clinically significant cardiac disease
Uncontrolled cardiac arrhythmia
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias currently requiring anti-arrhythmic therapy other than beta blockers
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function
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 must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Any of the following cardiac abnormalities or history
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 27%)
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Acute myocardial infarction or angina pectoris =< 6 months prior to starting study drug
Uncontrolled cardiac arrhythmia - patients with rate-controlled atrial fibrillation are not excluded
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
History of arrhythmia requiring an implantable cardiac defibrillator
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
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:\r\n* Active cardiac disease:\r\n** Angina pectoris that requires the use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; and\r\n** Symptomatic pericarditis\r\n*History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF); and\r\n** Documented cardiomyopathy
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
Patients with electrocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new rhythm, axis or ST segment changes will be included; if clinically significant, new EKG changes are present, patients may be included if cardiac stress test indicates no cardiac ischemia
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion in those over 50 years of age or with a known history coronary artery disease
Patients with recent (? 6 months) cardiac angina, difficult to control congestive\n             heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias\n             will be excluded
Cardiac arrhythmia requiring maintenance medication
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Patients must not have serious and inadequately controlled cardiac arrhythmia
Serious cardiac arrhythmia requiring medication
Cardiac ejection fraction < 30% or, if unable to obtain ejection fraction, shortening fraction of < 26%) on multi-gated acquisition (MUGA) scan or cardiac echo, symptomatic coronary artery disease, other cardiac failure requiring therapy; patients with a history of, or current cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consult; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
Decreased cardiac function with NYHA > Class 2
Impaired cardiac function or clinically significant cardiac disease
Significant history or risk of cardiac disease
Cardiac arrhythmia not controlled with medical management
History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
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.
Unstable/inadequate cardiac function:
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA
Significant active cardiac disease within the previous 6 months
Cardiac angioplasty or stenting
Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:
Significant cardiac arrhythmia
History or current evidence of cardiac arrhythmia and/or conduction abnormality
Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias; either an echocardiogram or multi-gated acquisition (MUGA) scan with an ejection fraction >= 45% must be obtained within 28 days prior to registration, or within 14 days prior to registration if the patient has received anthracycline in the 28 day window; (either method for measuring cardiac function is acceptable; however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity); if the patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration
Any of the following cardiac conditions:
No history of ventricular arrhythmias or severe cardiac dysfunction
Significant active cardiac disease within the previous 6 months from the signing of the ICD, including:
Significant active cardiac disease within the previous 6 months, including:
Significant cardiac arrhythmia or unstable angina or angina requiring surgical or medical intervention; and/or
Cardiac:
Cardiac Troponin I within normal limit.
History of ischemic cardiac disease that has occurred within 6 months prior to study entry.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Impaired cardiac function
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Significant cardiac event within 12 months before Cycle 1 Day 1.
History of arrhythmia requiring an implantable cardiac defibrillator;
Clinically significant active cardiac disease, uncontrolled heart disease and/or history of cardiac dysfunction including any of the following
No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months); any history of clinically significant cardiac failure
Abnormal cardiac status
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
History or evidence of cardiac disease as indicated by any of the following:
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Serious and inadequately controlled cardiac arrhythmia
Patient has active cardiac disease or a history of cardiac dysfunction
Uncontrolled or significant cardiac disease
Patients with a known history of cardiac disease. This includes:
Cardiac abnormalities
Known cardiac metastases
Uncontrolled cardiac or coronary artery disease
Left ventricular ejection fraction >= 45%, assessed within 3 months prior to study day 0, e.g. by multi gated acquisition scan (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographic suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
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
Pre-existing known cardiovascular abnormalities as defined by any one of the following: \t\r\n* Congestive heart failure \r\n* Clinically significant hypotension \r\n* Cardiac ischemia, or symptoms of coronary artery disease\r\n* Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy\r\n* Ejection fraction < 45% (echocardiogram or MUGA), although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of the trial
Pre-existing known cardiovascular abnormalities as defined by any one of the following: \t\r\n* Congestive heart failure \r\n* Clinically significant hypotension \r\n* Cardiac ischemia, or symptoms of coronary artery disease\r\n* Presence of cardiac arrhythmias on EKG requiring drug therapy\r\n* Ejection fraction < 45%, although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of this trial
Cardiac disease or dysfunction.
Cardiac abnormalities
Impaired cardiac function or clinically significant cardiac disease
Patients with impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac diseases.
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and/or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, or ongoing infection as manifested by fever
Any of the following cardiac conditions:
Known cardiac metastases
Have abnormal cardiac findings.
Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators
Cardiac arrhythmia
Pre-existing cardiac conditions
No evidence of significant cardiac or pulmonary dysfunction
Anyone with cardiac abnormalities or history
Cardiac disease
Have a serious concomitant systemic disorder or significant cardiac disease.
Cardiac arrhythmia requiring medical management and/or pacemaker
Cardiac arrhythmias requiring anti-arrhythmic therapy; Note: pace makers, beta blockers, or digoxin are permitted
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Any of the following cardiac criteria:
Active cardiac disease
Significant active cardiovascular or pulmonary disease at study entry ? History of arrhythmia requiring an implantable cardiac defibrillator
Presence of a cardiac pacemaker
Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin); patients with controlled atrial fibrillation are not excluded
Any of the following cardiac diseases currently or within the last 6 months:
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year prior to screening
Not requiring pressor support, not having symptomatic cardiac arrhythmias
Cardiac angioplasty or stenting
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Cardiac troponin I or cardiac troponin T levels above the limit of normal as specified by the manufacturer.
Significant cardiac impairment
History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
Unable to receive background chemotherapy based on prior treatment history and cardiac function
Any of the following cardiac criteria:
Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
Presence of cardiac metastases
Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
Atrial fibrillation or other cardiac arrhythmia requiring therapy
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year before screening
No currently unstable angina and/or uncontrolled cardiac arrhythmias
Significant cardiac disease within 6 months
No evidence of significant cardiac or pulmonary dysfunction
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients with significant history of cardiac disease will be evaluated by the investigator or his designee
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Impaired cardiac function (defined futher in the protocol)
Known impaired cardiac function including any one 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
Significant cardiac disease
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Evidence or history of significant cardiac disease
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.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
Patients with a serious cardiac condition within the past 6 months
Impaired cardiac function
Active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
Active cardiac disease, defined as (but not limited to):
Have adequate cardiovascular function as defined by: i) a normal B-type natriuretic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal electrocardiogram (ECG); if these criteria are not met, patients must have an echocardiogram or multigated acquisition cardiac scan (MUGA) showing an ejection fraction (EF) of 45% or greater with no more than \mild\ diastolic dysfunction and a BNP of < 200 pg/mL to be eligible
History of significant cardiac disorders:
Patients with impaired cardiac function or clinically significant cardiac disease:
Cardiac dysrhythmias;
Known impaired cardiac function or clinically significant cardiac disease
Patients with cardiac atrial or cardiac ventricular lymphoma involvement
DONOR: Adequate cardiac function by history and physical examination; those with a history of cardiac problems should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate
Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
Patients must have an electrocardiogram (EKG) that shows no significant abnormalities that are suggestive of active cardiac disease
Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by a urologist; evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications
Significant cardiac events
Inadequate cardiac function
Cardiac involvement
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
Impaired cardiac function or clinically significant cardiac diseases, history of arrhythmia (including ventricular fibrillation or torsade de pointes), bradycardia < 50 beats per minute (bpm), screening electrocardiogram (ECG) with prolonged corrected QT (QTc) or uncontrolled hypertension
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.
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
Cardiac abnormalities
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
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
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded
Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
Subject has ongoing cardiac arrhythmia (including atrial fibrillation) that is grade ?
Ongoing cardiac dysrhythmias
Acceptable cardiac function as indicated by protocol
History or evidence of cardiac risk.
Cardiac function: \r\n* ARM A: No evidence of uncontrolled heart failure or active angina\r\n* ARM B: No limitation
Cardiac function within normal range
History of cardiac disease
Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
Active cardiac disease or a history of cardiac dysfunction.
Significant cardiac dysfunction:
Clinically significant cardiac disease or impaired cardiac function
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
No evidence of significant cardiac or pulmonary dysfunction
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients will be evaluated by the investigator or his designee
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
Patients must not have known impaired cardiac function or clinically significant cardiac disease
serious cardiac arrhythmia.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
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)
Uncontrolled cardiac arrhythmia
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Cardiac involvement
Patient has any of the following cardiac abnormalities:
Serious uncontrolled cardiac arrhythmia.
Cardiac conditions
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Types of cardiac operations permitted:
Previous cardiac operation.
History of serious cardiac dysfunction
Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac\n             arrhythmia)
Unstable angina pectoris or cardiac arrhythmia
Cardiac arrhythmia requiring medication (does not include asymptomatic atrial fibrillation with controlled ventricular rate)
Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multigated acquisition scan [MUGA], stress echo or exercise stress test) for cardiac ischemia within 8 weeks prior to registration
Cardiac abnormalities:
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
Impaired cardiac function
Patients with intra-cardiac defibrillators
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrythmias classified as Lown III, IV or V.
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
No uncontrolled arrhythmias or symptomatic cardiac disease
The history or evidence of following cardiac abnormalities:
Abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (ECHO)
Subjects with intra-cardiac defibrillators or permanent pacemakers
Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
History or evidence of cardiac risk
Recent malignant cardiac arrhythmias – all except sinus arrhythmia within 24 weeks prior to screening
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Known cardiac/cardiopulmonary disease
Impaired cardiac function or clinically significant cardiac diseases.
Unstable angina pectoris or cardiac arrhythmia;
History of cardiac disease
PART II: Subjects with evidence of cardiac toxicity and Q wave abnormalities at baseline ECG will not be allowed to participate
Known cardiac/cardiopulmonary disease
Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Cardiac exclusions:
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Patients with intra-cardiac defibrillators
Known significant uncontrolled cardiac arrhythmias
Left ventricular ejection fraction >= 40%, assessed within 3 months prior to study day 1, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographical suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
Significant history of cardiac disease
Patients with cardiac arrhythmias must not be receiving anti-arrhythmic medication at time of study entry (or while on study).
Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks
Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
Serious and inadequately controlled cardiac arrhythmia
Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
Impaired cardiac function
History of heart failure or serious cardiac arrhythmia
History of significant cardiac dysfunction
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
History of severe cardiac disease.
Significant history of cardiac disease
Clinically significant cardiac disease or impaired cardiac function
Normal cardiac function cardiac function by appropriate image testing.
Major cardiac disease
Has cardiac status as described in protocol
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina\r\n* Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multi-gated acquisition scan [MUGA], stress echocardiography [echo], or exercise stress test) for cardiac ischemia within 8 weeks prior to registration\r\n* An echocardiogram should be performed at baseline in all patients; ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist; if the baseline cardiac stress test incorporates an echocardiogram, then this will not need to be done again at baseline
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Certain cardiac abnormalities.
Serious cardiac arrhythmia requiring medication; this does not include atrial fibrillation
impaired cardiac function
Patients with intra-cardiac defibrillators or permanent pacemakers.
Cardiac metastases
Significant active cardiac disease within the previous 6 months:
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Normal Cardiac function
Abnormal cardiac stress testing within last 6 months
Active cardiac disease;
Current or uncontrolled cardiac disease
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Impaired cardiac function or clinically significant cardiac diseases
Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease
Symptomatic or uncontrolled cardiac failure or coronary artery disease
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
All patients must have a stress test within 6 months of starting treatment showing no evidence of cardiac ischemia
Significant cardiac disease (i.e., left ventricular ejection fraction of < 50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
Active coronary disease with a positive cardiac stress test
Patients with unstable cardiac status including:
Serious accompanying cardiac disorder
Serious accompanying cardiac disorder.
Have a serious cardiac condition
History or evidence of cardiac abnormalities.
Presence of severe cardiac disease
Cardiac pacemakers
Have a cardiac pacemaker
Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal left ventricular (LV) function within 30 days of operation
Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
Patients with documented advanced cardiac or renal disease
Severe cardiac disease
Patients with any known significant cardiac abnormality.
Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
No known cardiac history (i.e., heart failure, myocardial infarction, or radiation-induced cardiac dysfunction)
Cardiac pacemaker
History of cardiac arrhythmias
Cardiac pacemaker
History of cardiac arrhythmia, controlled or uncontrolled, including ventricular and supraventricular arrhythmia
Impaired cardiac function including any of the following:
DONOR: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus brachycardia, sinus tachycardia or non?specific T wave changes) are ineligible for Triplex vaccination
Persons with acute cardiac or respiratory medical conditions, or who are pregnant/breastfeeding will not be eligible for participation
Cardiac ejection fraction < 30% on multi gated acquisition scan (MUGA) scan or cardiac echocardiogram (echo) or active symptomatic coronary artery disease; patients with cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consultation as clinically indicated
Unstable cardiac condition
Untreated or uncontrolled cardiovascular disease or other symptomatic cardiac dysfunction
Significant active cardiac disease within the previous 6 months, including:
Impaired cardiac function or clinically significant cardiac diseases
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Impaired cardiac function or clinically significant cardiac diseases
Impaired cardiac function
Subject has a permanent cardiac pacemaker.
normal cardiac function
Patients with history or evidence of cardiac dysfunction
Normal baseline cardiac function based upon pre-operative evaluation at the physician's discretion
Known cardiac shunt
History of congestive cardiac failure or an electrocardiography (EKG) suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study
Patients with known cardiac shunt
Unable to undergo MR imaging (e.g. cardiac device, metals, claustrophobia, etc.)
PATIENT: Patients with cardiac shunts or unstable cardiopulmonary conditions
Subject has any form of known cardiac arrhythmia
At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
Cardiac disease (cardiac viability assessment)
Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
Normal baseline cardiac function based upon pre-operative evaluation
Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease – congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
Patients with cardiac shunts or unstable cardiopulmonary conditions.
Patients with cardiac shunts or congenital heart defects
Patient must not have serious and inadequately controlled cardiac arrhythmia
Impaired cardiac function or clinically significant cardiac disease
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
Severe cardiac disease
New (< 6 months) cardiac arrhythmia (electrocardiogram [EKG] should be performed within 2 weeks of starting IFN gamma)
History of significant cardiac disease or uncontrolled arrhythmias
Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
Impaired cardiac function including any one of the following:
Normal cardiac conduction and function (centrally read)
Abnormal cardiac status with any of the following:
History of cardiac dysfunction including any of the following:
Known, clinically important cardiac or respiratory disease