Severe organ dysfunction unrelated to underlying GVHD, including:
Serum creatinine < mg/dl; NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
History of clinically significant cardiac dysfunction
History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment
History of clinically significant cardiac dysfunction
Major organ system dysfunction including (but not limited to): New York Heart Association class III or IV, pulmonary disease requiring the use of inhaled steroids or bronchodilators, renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction which would impair patients ability to participate in the trial
History of malabsorption or other clinically significant metabolic dysfunction
History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
Subjects with chronic liver disease or dysfunction
Any subject with a history of significant renal, hepatic, pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac dysfunction
Cardiopulmonary dysfunction
Evidence of renal or liver dysfunction at screening
History of clinically significant cardiac dysfunction
History of malabsorption or other clinically significant metabolic dysfunction
History of autoimmune disease, clinically significant cardiac or pulmonary dysfunction
Have a history of cardiac dysfunction including:
known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
History of clinically significant cardiac dysfunction
Patients with organ dysfunction
Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as
Liver dysfunction (or digestive involvement with protein loss)
Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI (see Section ..).
Must have a normal ejection fraction (within the reference range of the institution) and no clinically significant valvular dysfunction.
Patients with evidence of synthetic dysfunction or severe cirrhosis requiring deferral of conditioning as recommended by a gastroenterology specialist
Significant cardiopulmonary dysfunction
Acute neurological dysfunction as a result of bone metastasis.
Subject has evidence of hepatic dysfunction defined as:
Significant renal, hepatic, or bone marrow organ dysfunction.
Subjects must not have evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
No distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes
Patients with persistent LV dysfunction days after discontinuation of trastuzumab
Patients should have no evidence of immune dysfunction as listed below
Significant organ dysfunction defined as:
Patients with renal dysfunction or veno-occlusive disease are eligible
Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine >= ., cardiac ejection fraction =< %, total bilirubin >= and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] >= times upper limit of normal [ULN]), dose adjustments/omissions will be made
Severe liver dysfunction or pulmonary insufficiency
Severe liver dysfunction or pulmonary insufficiency
Patient has laboratory estimations indicating organ system dysfunction:
Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
Patients with persistent LV dysfunction days after discontinuation of trastuzumab
Patients with all degrees of renal dysfunction are allowed including patients on hemodialysis; patients with mild to severe hepatic dysfunction are allowed as defined below:
Patients with both hepatic and renal dysfunction will also be excluded
Patients receiving medications for treatment of left ventricular systolic dysfunction
Organ dysfunction or disease that would jeopardize survival after hematopoietic cell transplantation, including but not limited to the following: \r\n * Renal insufficiency as defined by an estimated glomerular filtration rate (GFR) < mL/minute\r\n * Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction < %\r\n * Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pulmonary disease-moderate, using pre-transplant pulmonary function testing per the Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Manual\r\n * Necroinflammatory or fibrotic liver disease with evidence of liver dysfunction, including but not limited to jaundice, hepatic encephalopathy, or portal hypertension\r\n * Marrow dysfunction that poses a risk of peri-transplant mortality, defined as an absolute neutrophil count or lymphocyte count below the lower limit of normal, or a platelet count below ,/mm^\r\n * Poorly controlled hypertension despite appropriate therapy, defined as a diastolic blood pressure greater than mm Hg while on therapy\r\n * Neurologic dysfunction that affects activities of daily living and medical care\r\n * Poorly controlled diabetes mellitus, defined as persistent hyperglycemia despite therapy or recurrent hypoglycemia while on therapy\r\n * Extreme protein-calorie malnutrition defined by body mass index < kg/m^ and unintentional weight loss ( kg in the last month or kg in the last months)
Patients with normal, mild or moderate hepatic dysfunction are eligible
With hepatic dysfunction as evidenced by total bilirubin > . x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > . x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
Patients with significant hepatic dysfunction (not meeting liver function tests [LFT] eligibility criteria)
Patients should have no evidence of immune dysfunction
Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
Severe organ dysfunction unrelated to underlying GVHD, including:
Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).
No history of ventricular arrhythmias or severe cardiac dysfunction
Clinically significant cardiac or pulmonary dysfunction
Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion)
Any other concomitant serious illness or organ system dysfunction as per investigator assessment
History of clinically significant cardiac or pulmonary dysfunction
Cardiovascular dysfunction or Respiratory Failure due to sepsis.
Cardiac disease or dysfunction.
No evidence of significant cardiac or pulmonary dysfunction
Subjects with severe (immediately life threatening) and recent (occurring within the last months) cardiac dysfunction, pulmonary dysfunction, esophageal variceal bleeding, hemorrhagic strokes, or intracranial hemorrhage are not eligible for study participation
No evidence of significant cardiac or pulmonary dysfunction
Cardiopulmonary dysfunction as defined by protocol
Have a history of liver or renal dysfunction
Significant co-morbidity indicated by major organ system dysfunction
Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
Failure of of the following drugs: interferon-betab, interferon beta a, and glatiramer acetate; failure is defined by new or progressive physical signs and symptoms that impair activities of daily living; such changes include cognitive decline, vision loss, swallowing dysfunction, limb weakness, limb plasticity, bowel or bladder dysfunction, and coordination or gait dysfunction; these clinical changes should be supported by new or expanding lesions on MRI scanning consistent with disease progression
Creatinine < mg %; patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman
Bilirubin < mg %; patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman
Serious organ dysfunction
Significant hepatic dysfunction, renal dysfunction, or metabolic derangement that precludes full-dose chemotherapy at the specified starting doses
Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
Any organ dysfunction thought to be secondary to disease will be considered separately and the patient will be included at the investigators discretion
History of symptomatic pulmonary dysfunction
Significant cardiac dysfunction:
Known systolic or diastolic dysfunction or heart failure
No evidence of significant cardiac or pulmonary dysfunction
Severe organ dysfunction manifested during screening period:
Laboratory evidence of hepatic dysfunction indicated by any of the following:
Significant organ dysfunction.
History of clinically significant cardiac dysfunction
Hepatic dysfunction defined as MELD Score > .
History of serious cardiac dysfunction
Significant organ dysfunction deemed to be inappropriate for autologous transplantation
Clinically important genital/urinary tract dysfunction
Liver/renal dysfunction
Any medications for treatment of left ventricular systolic dysfunction.
History of significant cardiac dysfunction
Clinically significant cardiac or pulmonary dysfunction
In hepatic dysfunction group, patients with hepatic dysfunction who have Gilbert's syndrome. Patients signs of encephalopathy (altered brain function).
Evidence of at least new onset organ dysfunction
No specific organ function parameters are required; however, significant abnormalities should be discussed with the study PI (this is especially the case for significant renal dysfunction)
History of clinically significant cardiac or pulmonary dysfunction
Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
Patients unable to use audio media due to auditory dysfunction
Presence of erectile dysfunction symptoms
Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
History of known renal dysfunction
Severe organ dysfunction.
Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction)
Have renal dysfunction
History of hepatitis or liver dysfunction
Current or history of hepatic dysfunction
Untreated or uncontrolled cardiovascular disease or other symptomatic cardiac dysfunction
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
Patients must not have evidence of significant hematologic, renal, or hepatic dysfunction
History of known renal dysfunction
Renal dysfunction for which cisplatin dose would be considered unsafe
Patients with history or evidence of cardiac dysfunction
Sinus node dysfunction
Have a history of liver or renal dysfunction
History of clinically significant cardiac dysfunction
History of cardiac dysfunction including any of the following: