Child-Pugh score A within 14 days prior to study entry
If liver cirrhosis is present, patient must have a Child-Pugh A or B (7 points) classification.
Patient with a Child-Pugh score B or C
Child-Pugh Score 5 or 6
Child-Pugh score B or C (for cirrhosis patients only)
Child-Pugh score A
Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
Patient with a Child-Pugh score B or C
Cirrhosis with Child-Pugh score > 7
Child-Pugh score A or B7
Patients with chronic liver disease with a Child-Pugh score B or C
Severe liver dysfunction (Child-Pugh Class B or C) is not present; and
Child Pugh score A5, A6, B7 or B8
Child Pugh score B9 or C10
Child-Pugh Score class A
Child-Pugh class A
Patient with a Child-Pugh score B or C
Child-Pugh score of A
Childs-Pugh cirrhotic status A or B with a maximum score of 7
Patient with a Child-Pugh score B or C
Baseline severe hepatic impairment (Child-Pugh Class B & C)
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the Child Pugh classification)
Child Pugh B or C stage liver disease
Child Pugh B or C disease
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Patients with liver disease classified as Child Pugh class A or B, with score =< 9
Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert disease.
Cirrhosis of the liver, Child-Pugh Stage B or C, or history of liver transplant,
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Child-Pugh score > 7
Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction
Chronic liver disease, Child-Pugh class B or C
Hepatic impairment Child-Pugh < B7.
Child-Pugh score A
Child-Pugh score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.
Patients with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C
CRITERIA SPECIFIC FOR COHORT #2 (MCL): Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Child Pugh A score 5 or 6 liver function
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Childs Pugh A (5-6 points)
Impaired liver function Child-Pugh class B or C (score 7-15).
Baseline moderate and severe hepatic impairment (Child Pugh class B & C)
Subjects must have a Child-Turcotte-Pugh (CTP) score =< 7 to be eligible
Child-Pugh class B and C liver failure
Subjects with child Pugh B or C cirrhosis; patients with child Pugh A cirrhosis will be excluded from the dose escalation portion of the trial but can be included in the dose expansion portion of the trial with one dose reduction from the established dose
Child-Pugh score of A
Severe hepatic impairment (Child-Pugh Class C).
Subjects with severe hepatic insufficiency Child-Pugh score > 6
Child-Pugh scores 5-7
Obtained with 21 days of registration: Child Pugh class A (5-6 points) or B (7 points)
Child Pugh class B (8,9) and class C are excluded.
If patient has underlying cirrhosis, only Child-Pugh classification group A patients should be included in this study; clinical assessment of ascites and encephalopathy is required; Child-Pugh classification must be determined for all study participants at the time of eligibility analysis; as albumin and prothrombin time (PT)/international normalized ratio (INR) are required for Child-Pugh classification; these labs should be drawn with other labs required for eligibility analysis
Patients with cirrhosis and severe synthetic liver dysfunction (Child Pugh B-C)
Child-Pugh class-A liver function
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.
Child Pugh class A (score = 5 or 6) cirrhosis (assessed within 14 days of SBRT)
Patients with Child Pugh B or C liver failure will be excluded
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Subject with a Child-Pugh score B or C.
Patient with a Child-Pugh score B or C
Subjects with chronic liver disease with hepatic impairment Child-Pugh class B or C
Child-Pugh class A or B7 liver function
Currently active, clinically significant hepatic impairment Child-Pugh class A, B or C according to the Child Pugh classification
Patients with baseline moderate to severe hepatic impairment (Child-Pugh class B and C)
Obtained =< 14 days prior to registration: If baseline liver disease, Child Pugh score not exceeding class A
Hepatic impairment:\r\n* Phase I: any currently active, clinically significant hepatic impairment (Child-Pugh class A, B, or C according to the Child Pugh classification)\r\n* Phase II: currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Child Pugh class B or greater hepatic dysfunction
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Child-Pugh A or B7
Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Have a Child-Pugh A liver score within 7 days of first dose of study drug
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Child-Pugh cirrhotic status A or B with a score of 7
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Underlying hepatic cirrhosis with Child-Pugh class B9 or C
Child Pugh class B & C
If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification
Patients with severe chronic liver disease (Child-Pugh score > 10)
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Patients with a Child-Pugh score less than 6 or greater than 9 for radiation naive patients with cirrhosis (cohort 1)
Child-Pugh score of greater than 6 for patients with cirrhosis who previously received liver directed radiation (EBRT or Y90 RE) (cohort 3)
Child-Pugh score 8 or greater
Patient with a Child-Pugh score B or C
Several hepatic impairments, define as Child-Pugh Class C or worse
Child-Pugh class A or B7 without ascites
Child-Pugh score of A
Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh class B or C
Child-Pugh score must be A to B7.
Must have Child-Pugh A or B liver disease
Child-Pugh C liver function
Child Pugh class C hepatic dysfunction
Subject has hepatic decompensation (Child-Pugh score > 6 [class B and C])
Have Child B/C cirrhosis
The Child Pugh score must be 5 or 6 (Child Pugh class A)
No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7
Patients with Child-Pugh A and Child-Pugh B7 (if due to low albumin but not elevated international normalized ratio [INR] or bilirubin) cirrhosis are allowed; Child-Pugh Turcot (CPT) Classification System score will be based upon INR, total bilirubin and serum albumin, as well as the presence/absence of ascites and hepatic encephalopathy
Child-Pugh B (except Child-Pugh B7 due to low albumin) or Child-Pugh C cirrhosis
Child Pugh score A or B
Child-Pugh status C
Cirrhosis classified as Child-Pugh Class B (Appendix C).
Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
Child-Pugh Class A without either current encephalopathy or ascites.
Child-Turcotte-Pugh Classification A or B
Hepatic cirrhosis or a Child-Pugh score of C (severe hepatic impairment) at the time of randomization.
Baseline moderate or severe hepatic impairment (Child Pugh class B & C)
Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
Child-Pugh Class A
Subjects with chronic liver disease with hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Cirrhotic status of Child-Pugh class A or B
Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
Child-Pugh score A
Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ?6 and Model for End-Stage Liver Disease (MELD) score?15
Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ?6 and Model for End-Stage Liver Disease (MELD) score?15
Liver disease with Child-Pugh class B or C liver dysfunction
Cirrhosis of any Child Pugh class
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Has hepatic decompensation (Child-Pugh score > 6; = class B and C)
HCC patients only: Child Pugh class A or B7 liver disease
Must have Child-Turcotte-Pugh (CTP) A or B7
Patient with severe liver impairment (Child Pugh score B/C)
Severe hepatic impairment (Child-Pugh class C)
ARM B: Child Pugh Score A
Subjects with known hepatic insufficiency (i.e. Child-Pugh score A [mild], Child-Pugh score B [moderate] or Child-Pugh score C [severe]) according to Child-Pugh criteria
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
Patient with a Child-Pugh score B or C
Patient with a Child-Pugh score B or C (for cirrhosis patients only)
Subject is classified into Child-Pugh class C
Child-Pugh score of A or B with =< 7 points and meeting laboratory eligibility for all parameters
Child-pugh B or C cirrhosis.
Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug.
Child-Pugh Score of A.
Patients with Child pugh score B or C
cirrhosis at a level of Child-Pugh B (or worse)
Cirrhosis with Child-Pugh score of B or C
Patients with Child-Pugh A-C liver disease
Subject is classified into Child-Pugh class C
Subject has Child-Pugh score of ?6, i.e., Child-Pugh A (Appendix 2);
Patient with a Child-Pugh score B or C
Child-Pugh Class A
Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less
Moderate or severe hepatic impairment defined as Child-Pugh class B or C
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child-Pugh classification
Patients with hepatocellular carcinoma may be eligible provided they have total bilirubin ? 3.0 x ULN and are considered Child-Pugh Class A or Child-Pugh Class B7 (Child-Pugh Class B with a total Child-Pugh score not to exceed 7).
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh classification)
Child Pugh score ? 7 points
Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher.
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
cirrhosis at a level of Child-Pugh B (or worse) or
Child-Pugh score A
Patients with liver disease Child Pugh classification B and C.
Child-Pugh score of 10-15 (Class C)
Patient with Child-Pugh score B or C
Preserved liver function (Child-Pugh class A or B)
Patients with Child Pugh class B or C hepatic cirrhosis
Child Pugh score =< 10
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Subject has hepatic function status of Child Pugh Class A at Screening.
Subject has status of Child-Pugh Class B or C at Screening.
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.
Severe hepatic impairment (Child-Pugh class C)
Subjects with currently active, clinically significant hepatic impairment (> moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification)
Child Pugh B and C
Patient must not have currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh)
Severe hepatic impairment (Child-Pugh class C)
Liver cirrhosis ? Child-Pugh class B with uncontrolled ascites
Severe hepatic impairment (Child-Pugh class C)
Child-Pugh class A
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
Cirrhosis grade of Child-Pugh class A; Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification)
If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification
Child-Pugh score =< 7 (Child A-B)
Non-cirrhotic or no more than Child-Pugh A cirrhosis
Child-Pugh liver function class A
No cirrhosis or Child-Pugh A (Child-Turcotte-Pugh [CTP] score < 7) cirrhosis
Child-Pugh B or C cirrhosis (CTP score >= 7)
Liver function status Child-Pugh Class A. Child Pugh status should be calculated based on clinical findings and laboratory results during the screening period. Local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >/=4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intraarterial chemotherapy, without lipiodol or embolizing agents are not eligible.
Child Pugh score =< 10
Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
If cirrhosis, Child-Pugh classification A or B
Systemic disease that would prevent study treatment (uncontrolled hypertension, cardiovascular renal, hepatic (including Child-Pugh Class B and C) or metabolic disease)
Child-Pugh Class A or B.
Patients with Child-Pugh B or C hepatic impairment
Subject has Child-Pugh score of less than 7 (ie, class A or better) with neither encephalopathy nor clinically significant ascites (ascites requiring paracentesis within 3 months of signing the ICF is excluded). Child-Pugh status is calculated based on clinical findings and laboratory results during the screening period.
Serum albumin of at least 2.8 g/dL Note: Laboratories in combination must still be Child Pugh score less than 7 Other laboratory parameters:
Hepatic impairment (Child Pugh classes A-C) that is not considered to be the result of leukemic involvement as determined by the PI
Decompensated liver disease (Child-Pugh score > 6) or active or past auto-immune hepatitis
Moderate and severe hepatic impairment, ie Child-Pugh B or C
Currently active, clinically significant hepatic impairment (? moderate hepatic impairment according to the Child Pugh classification).
Patients with severe hepatic impairment (Child-Pugh class C)
Patients with severe hepatic impairment (Child-Pugh class C)
Child Pugh Class A disease
Child Pugh A
For patients with hepatocellular carcinoma only, Child-Pugh Class A (score 5-6) disease. Score for hepatic encephalopathy must be 1; the score for ascites must be no greater than 2 and clinically irrelevant; for the determination of the Child-Pugh Class.
Patients with cirrhosis classed as Child-Pugh B or C.
Child-Pugh class A with no clinically apparent ascites
Severe hepatic impairment (Child-Pugh class C)
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
Have liver cirrhosis with a Child-Pugh Stage of B or C.
Child-Pugh class of A
Severe hepatic impairment (Child-Pugh class C)
Child-Pugh Class B and C.
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
Patients with impaired hepatic function as defined by Childs-Pugh class B or C
If patient has underlying cirrhosis, only Child-Pugh classification Group A patients may be included in the resectable cohort of this study; for patients with unresectable disease, Child-Pugh classification Groups A and B are allowed; clinical assessment of ascites and encephalopathy is required; Child-Pugh classification must be determined for all study participants at the time of eligibility analysis; note albumin and prothrombin time (PT)/international normalized ratio (INR) are required for Child-Pugh classification; these laboratories (labs) should be drawn with the other labs required for eligibility analysis
Hepatic function with a score of < 7 points according to the Child-Pugh System
Currently active, clinically significant hepatic impairment >= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
Subjects with impaired hepatic function will be grouped according to Child-Pugh classification score
Child Pugh Class A liver function score
Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix B). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
Child-Pugh Classification A (see Appendix D)
Child-Pugh Score A (5-6)
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
Moderate and severe hepatic impairment, i.e. Child-Pugh B or C
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).
Child-Pugh B-C cirrhotic status based on clinical findings and laboratory results
Must be Child-Pugh class A a. Patients with uncontrolled massive ascites or presence of hepatic encephalopathy are excluded
Significant liver dysfunction determined as Child-Pugh score B or C
Patients with severe hepatic impairment (Child-Pugh class C)
Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A
Child-Pugh class B or C hepatic impairment
Child Pugh class A or B7 liver disease
If liver cirrhosis is present, patient must have a Child-Pugh A or B (7 points) classification
Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C.
ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
Child-Pugh Class A.
cirrhosis at a level of Child-Pugh B (or worse) or
Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
History of cirrhosis of the liver based on the Child-Pugh score of Class B or C are not eligible to participate. (Appendix B.)
Child-Pugh Class A in the absence of hepatoencephalopathy or clinically evident ascites
Hepatic function with a score of 7-9 points according to the Child-Pugh System
Child Pugh class A liver function or class B7
Patients with Child Pugh liver function worse than B7
No severe hepatic impairment (Child-Pugh class C) or acute liver disease
Patients with severe hepatic dysfunction (Child Pugh class C)
Moderately impaired hepatic function (Child-Pugh B) or severe hepatic impairment (Child-Pugh C)
Severe hepatic impairment (Child-Pugh class C)
Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
Subjects with severe hepatic insufficiency (Child Pugh score > 9)
Severe liver impairment (Child-Pugh score > 9)
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Child-Pugh Score of up to B7
Child-Pugh score of up to B7
Child-Pugh score A
Child-Pugh category A
Child-Pugh score <7 (Child-Pugh Class A).
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Individuals with a clinical diagnosis fibrosis or cirrhosis of the liver (no more than Child-Pugh classification A; Child-Pugh-Turcotte score of 6 or less) who have:\r\n* An indication for surgical liver resection, OR\r\n* A clinical liver biopsy (with research tissue specimens available for analysis) =< 3 months prior to pre-registration
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Currently active, clinically significant hepatic impairment (Child-Pugh class B or C)
Child-Pugh class B and C liver failure
Patients with severe hepatic impairment (Child-Pugh class C)
Childs-Pugh Class C cirrhosis
Known cirrhosis diagnosed with Child Pugh class A or higher liver disease
Child Pugh A or B
Child-Pugh A/B
Moderate or severe hepatic insufficiency Child-Pugh score > 6
Child-Pugh liver function Class B or C.
Child-Pugh score ? 6
Child Pugh C cirrhosis or other significant comorbid conditions