Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

Exclusion Criteria

• •Richter's transformation in current relapse or active disease
• •Prior allogeneic HCT
• •Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or participation in any other interventional clinical study
• •Non-response to monotherapy with ofatumumab prior to study inclusion
• •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (left ventricular ejection fraction \< 50%)
• •Abnormal renal function defined by an estimated GFR \< 50 ml/min
• •Abnormal lung function tests defined by a DLCO \<50%, FEV1%VC \<70% despite appropriate treatment
• •Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg or HBcAb
• •Positive serology for hepatitis C (HC) defined as a positive test for anti-HCV, confirmed by PCR
• •Screening laboratory values:
• •* total bilirubin \>1.5 times upper normal limit (unless due to AIHA or a known history of Gilbert's disease)
• •* ALT or AST \>2.5 times upper normal limit
• •* Gamma glutamyl transpeptidase (GGT) \>2.5 times upper normal limit (unless due to disease involvement of the liver)
• •Other past or current hematologic or solid organ malignancy. Subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
• •Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
• •Pregnant or lactating woman
• •Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.