Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse

Exclusion Criteria

• •Central nervous system involvement,
• •Chemotherapy, radiation therapy or any other antineoplastic treatment (including steroids, monoclonal antibodies or medications at the stage of clinical studies, before receiving marketing authorisation) after ASCT and before administration of the study medication,
• •Major surgery within 28 days prior to the study treatment initiation,
• •Renal impairment (plasma creatinine concentration \> 1.5 × upper limit of normal and/or creatinine clearance ≤ 40 ml/h),
• •Hepatic impairment (total bilirubin concentration \> 1.5 × upper limit of normal, AST and ALT \> 2.5 × upper limit of normal),
• •Hb\< 9 g/dl, ANC \< 1.5 G/l, platelets \< 75 G/l,
• •International normalized ratio (INR) \> 1.5,
• •Clinically significant heart disease, including uncontrolled arrhythmias, unstable coronary artery disease, serious congestive circulatory failure (NYHA III-IV), myocardial infarction within 6 months before enrolment,
• •Other comorbidities, not responding to treatment, including, but not limited to: hematopoietic system diseases, gastrointestinal system diseases, endocrine system diseases, respiratory system diseases, neurological diseases, cerebral diseases and mental diseases that could affect compliance with the protocol or interpretation of results,
• •Active infections (viral, bacterial, fungal),
• •Coexistence of another neoplasm or a history of neoplastic disease (except for adequately treated basal cell carcinoma or squamous cell skin carcinoma, in situ cervical cancer or other neoplasm if the patient is in complete remission after at least 5 years of treatment discontinuation),
• •Active HIV, HBV or HCV infection,
• •Positive testing for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing). Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA,
• •Vaccination with live vaccines within 28 days prior to start of the preemptive treatment,
• •Known or suspected hypersensitivity to the study medication,
• •Women who are pregnant or breastfeeding.