Child-Pugh score A within 14 days prior to study entry
Patient with a Child-Pugh score B or C
Child-Pugh Score 5 or 6
Child-Pugh score A
Patient with a Child-Pugh score B or C
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
Patient with a Child-Pugh score B or C
Child Pugh B or C stage liver disease
Child Pugh B or C disease
Patients with liver disease classified as Child Pugh class A or B, with score =< 9
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
Child-Pugh score A
Child-Pugh score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.
Child Pugh A score 5 or 6 liver function
Impaired liver function Child-Pugh class B or C (score 7-15).
Subjects must have a Child-Turcotte-Pugh (CTP) score =< 7 to be eligible
Child-Pugh class B and C liver failure
Child-Pugh score of A
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.
Child-Pugh class-A liver function
Patients with Child Pugh B or C liver failure will be excluded
Subject with a Child-Pugh score B or C.
Patient with a Child-Pugh score B or C
Child-Pugh class A or B7 liver function
Obtained =< 14 days prior to registration: If baseline liver disease, Child Pugh score not exceeding class A
Child-Pugh A or B7
Have a Child-Pugh A liver score within 7 days of first dose of study drug
Child-Pugh cirrhotic status A or B with a score of 7
Child Pugh class B & C
Patients with severe chronic liver disease (Child-Pugh score > 10)
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
Child-Pugh score must be A to B7.
Must have Child-Pugh A or B liver disease
Child-Pugh C liver function
Subject has hepatic decompensation (Child-Pugh score > 6 [class B and C])
The Child Pugh score must be 5 or 6 (Child Pugh class A)
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
Child-Pugh Class A without either current encephalopathy or ascites.
Child-Turcotte-Pugh Classification A or B
Child-Pugh Class A
Cirrhotic status of Child-Pugh class A or B
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
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)
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
Patient with a Child-Pugh score B or C
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
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
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
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).
Child Pugh score ? 7 points
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug
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)
Child Pugh score =< 10
Subject has hepatic function status of Child Pugh Class A at Screening.
Subject has status of Child-Pugh Class B or C at Screening.
Child Pugh B and C
Child-Pugh class A
Child-Pugh score =< 7 (Child A-B)
Child-Pugh liver function class A
Child Pugh score =< 10
Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
Child-Pugh Class A or B.
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:
Decompensated liver disease (Child-Pugh score > 6) or active or past auto-immune hepatitis
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.
Child-Pugh class A with no clinically apparent ascites
Child-Pugh class of A
Child-Pugh Class B and C.
Hepatic function with a score of < 7 points according to the Child-Pugh System
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)
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
Child Pugh class A or B7 liver disease
ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
Child-Pugh Class A.
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
Subjects with severe hepatic insufficiency (Child Pugh score > 9)
Severe liver impairment (Child-Pugh score > 9)
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).
Child-Pugh class B and C liver failure
Child Pugh A or B
Child-Pugh A/B
Child-Pugh liver function Class B or C.
Child-Pugh score ? 6
If liver cirrhosis is present, patient must have a Child-Pugh A or B (7 points) classification.
Child-Pugh score B or C (for cirrhosis patients only)
Cirrhosis with Child-Pugh score > 7
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,
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
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 (score = 5 or 6) cirrhosis (assessed within 14 days of SBRT)
Liver cirrhosis or chronic liver disease Child-Pugh B or C
Underlying hepatic cirrhosis with Child-Pugh class B9 or C
If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification
Total bilirubin; if cirrhosis present: part of Child Pugh requirement; if no cirrhosis: bilirubin should be =< 2 x upper limit of normal (ULN)
Serum albumin; if cirrhosis present: part of Child Pugh requirement; if no cirrhosis: albumin should be >= 2.5 g/dl
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)
No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7
Cirrhosis classified as Child-Pugh Class B (Appendix C).
Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
Cirrhosis of any Child Pugh class
Patient with a Child-Pugh score B or C (for cirrhosis patients only)
Child-pugh B or C cirrhosis.
cirrhosis at a level of Child-Pugh B (or worse)
Cirrhosis with Child-Pugh score of B or C
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.
cirrhosis at a level of Child-Pugh B (or worse) or
Patients with Child Pugh class B or C hepatic cirrhosis
Liver cirrhosis ? Child-Pugh class B with uncontrolled ascites
Cirrhosis grade of Child-Pugh class A; Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification
Total bilirubin\r\n* If cirrhosis present: part of Child Pugh requirement\r\n* If no cirrhosis: bilirubin (bili) should be =< 2 x upper limit of normal (ULN)
Serum albumin\r\n* If cirrhosis present: part of Child Pugh requirement\r\n* If no cirrhosis: albumin should be >= 2.5 g/dl
Non-cirrhotic or no more than Child-Pugh A cirrhosis
No cirrhosis or Child-Pugh A (Child-Turcotte-Pugh [CTP] score < 7) cirrhosis
Child-Pugh B or C cirrhosis (CTP score >= 7)
If cirrhosis, Child-Pugh classification A or B
Patients with cirrhosis classed as Child-Pugh B or C.
Have liver cirrhosis with a Child-Pugh Stage of 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
Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A
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.
Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant
cirrhosis at a level of Child-Pugh B (or worse) or
History of cirrhosis of the liver based on the Child-Pugh score of Class B or C are not eligible to participate. (Appendix B.)
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
Known cirrhosis diagnosed with Child Pugh class A or higher liver disease
Child Pugh C cirrhosis or other significant comorbid conditions
Baseline severe hepatic impairment (Child-Pugh Class B & C)
Hepatic impairment Child-Pugh < B7.
Patients with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C
Baseline moderate and severe hepatic impairment (Child Pugh class B & C)
Severe hepatic impairment (Child-Pugh Class C).
Subjects with chronic liver disease with hepatic impairment Child-Pugh class B or C
Patients with baseline moderate to severe hepatic impairment (Child-Pugh class B and C)
Child Pugh class B or greater hepatic dysfunction
Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)
Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh class B or C
Child Pugh class C hepatic dysfunction
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)
Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
Severe hepatic impairment (Child-Pugh class C)
Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
Moderate or severe hepatic impairment defined as Child-Pugh class B or C
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.
Severe hepatic impairment (Child-Pugh class C)
Severe hepatic impairment (Child-Pugh class C)
Severe hepatic impairment (Child-Pugh class C)
Patients with Child-Pugh B or C hepatic impairment
Hepatic impairment (Child Pugh classes A-C) that is not considered to be the result of leukemic involvement as determined by the PI
Moderate and severe hepatic impairment, ie Child-Pugh B or C
Patients with severe hepatic impairment (Child-Pugh class C)
Patients with severe hepatic impairment (Child-Pugh class C)
Severe hepatic impairment (Child-Pugh class C)
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
Severe hepatic impairment (Child-Pugh class C)
Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
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).
Patients with severe hepatic impairment (Child-Pugh class C)
Child-Pugh class B or C hepatic impairment
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.
Patients with severe hepatic impairment (Child-Pugh class C)
Moderate or severe hepatic insufficiency Child-Pugh score > 6
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the Child Pugh classification)
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
CRITERIA SPECIFIC FOR COHORT #2 (MCL): 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
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
Currently active, clinically significant hepatic impairment Child-Pugh class A, B or C according to the Child Pugh classification
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
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
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
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
Subjects with chronic liver disease with 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
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child-Pugh classification
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh classification)
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
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Subjects with currently active, clinically significant hepatic impairment (> moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification)
Patient must not have currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh)
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
Currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification)
Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
Currently active, clinically significant hepatic impairment (? moderate hepatic impairment according to the Child Pugh classification).
Currently active, clinically significant hepatic impairment >= moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Currently active, clinically significant hepatic impairment (Child-Pugh class B or C)
Known Childs class B or C hepatic cirrhosis or severe pre-existing hepatic impairment
Childs-Pugh cirrhotic status A or B with a maximum score of 7
Childs Pugh A (5-6 points)
Child’s class C liver disease or worse
Childs B or C cirrhosis
Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B (but, =< Childs score B8)\r\n* NOTE: If the patient does not have histological confirmation of disease by biopsy, diagnosis of HCC must be documented with approval by a tumor board or other multidisciplinary conference
Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies
Childs’ class A or B7
Childs B or C cirrhosis
Childs score of A or B
Child’s class C
Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
Patients with impaired hepatic function as defined by Childs-Pugh class B or C
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Known chronic liver disease (Child’s B cirrhosis)
Childs-Pugh Class C cirrhosis