. 2019 Dec 19;8(4):IJH20. doi: 10.2217/ijh-2019-0010

Table 1. . Inclusion and exclusion criteria.

ImbruVeRCHOP inclusion and exclusion criteria
– Age, ≥61 years and ≤80 years – CD20-positive DLBCL; including T-cell-rich large B-cell lymphoma, anaplastic large B-cell lymphoma, plasmablastic lymphoma (if CD20⁺); follicular lymphoma grade 3b or primary transformed follicular lymphoma at initial diagnosis – Unfavorable risk profile, IPI ≥2 – Performance status (ECOG) 0–2 – Cardiac ejection fraction ≥50 % – Hemoglobin ≥9 g/dl, absolute neutrophil count ≥100/μl and platelet count ≥100,000/μl – Adequate renal function as documented by serum creatinine level <2 x ULN or estimated GFR ≥40 ml/min/1,73 m² – Adequate hepatic function (total bilirubin ≤15 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of nonhepatic origin, ALT and AST ≤3 x ULN)	– Secondary transformed B-NHL or types of NHL other than DLBCL and its subtypes according to WHO classification – Prior therapy for DLBCL – Known central nervous system lymphoma – Central nervous system involvement by lymphoma – Major surgery within 4 weeks prior to start of induction therapy – History of stroke or intracranial hemorrhage within 6 months prior to study entrance – Anticoagulation with vitamin K antagonists – Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or any NYHA stage 3 or 4 – HIV or active Hepatitis C virus or active Hepatitis B virus infection – Prior malignancy (except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical cancer in situ, or any other cancer for which the patient has been in remission for at least 5 years) – Pre-existing polyneuropathy of any kind >grade I – Severe chronic obstructive pulmonary disease with hypoxemia

ImbruVeRCHOP inclusion and exclusion criteria

Inclusion criteria

Exclusion criteria

– Age, ≥61 years and ≤80 years
– CD20-positive DLBCL; including T-cell-rich large B-cell lymphoma, anaplastic large B-cell lymphoma, plasmablastic lymphoma (if CD20⁺); follicular lymphoma grade 3b or primary transformed follicular lymphoma at initial diagnosis
– Unfavorable risk profile, IPI ≥2
– Performance status (ECOG) 0–2
– Cardiac ejection fraction ≥50 %
– Hemoglobin ≥9 g/dl, absolute neutrophil count ≥100/μl and platelet count ≥100,000/μl
– Adequate renal function as documented by serum creatinine level <2 x ULN or estimated GFR ≥40 ml/min/1,73 m²
– Adequate hepatic function (total bilirubin ≤15 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of nonhepatic origin, ALT and AST ≤3 x ULN)

– Secondary transformed B-NHL or types of NHL other than DLBCL and its subtypes according to WHO classification
– Prior therapy for DLBCL
– Known central nervous system lymphoma
– Central nervous system involvement by lymphoma
– Major surgery within 4 weeks prior to start of induction therapy
– History of stroke or intracranial hemorrhage within 6 months prior to study entrance
– Anticoagulation with vitamin K antagonists
– Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or any NYHA stage 3 or 4
– HIV or active Hepatitis C virus or active Hepatitis B virus infection
– Prior malignancy (except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical cancer in situ, or any other cancer for which the patient has been in remission for at least 5 years)
– Pre-existing polyneuropathy of any kind >grade I
– Severe chronic obstructive pulmonary disease with hypoxemia

DLBCL: Diffuse large B-cell lymphoma; ECOG: The Eastern Cooperative Oncology Group; GFR: Glomerular filtration rate; IPI: International Prognostic Index; NHL: Non-Hodgkin's lymphoma; NYHA: The New York Heart Association; ULN: Upper limit normal.