Inclusion
Documented CD20+ B-cell CLL according to NCI/IWCLL criteria (Hallek et al. 2008)
Previously untreated CLL requiring treatment according to NCI/IWCLL criteria (Hallek et al. 2008).
CIRS score >= 6
Age >= 65 years old
An ECOG performance status score of 0-2 at Screening
Able to comply with study protocol procedures and a minimum of 14 months of follow-up
Has provided written informed consent
Life expectancy at least 6 months
Haematological parameters at Screening as defined by:
a. ANC (segs + bands) >1.5 x 10^9/L unless related to CLL
b. Platelet count >50 x 10^9/L
Calculated creatinine clearance >= 40ml/min at Screening (Cockcroft-Gault formula)
In men who are not surgically sterile, must agree to use a barrier method of contraception for >= 3 months after the last obinutuzumab dose. In addition, male participants must agree to request that their female partners of childbearing potential use an additional method of contraception.
Exclusion
Patients who have received previous CLL treatment
Transformation of CLL to aggressive NHL (Richter’s transformation)
Prior treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1, unless administered for indications other than CLL at a dose equivalent to less than or equal to 30 mg/day prednisolone
Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying leukemia):
a. AST or ALT > 2.5 × ULN
b. Total bilirubin greater than or equal to 3 × ULN
One or more individual organ / system impairment score(s) of 4 as assessed by the CIRS definition, excluding the Eyes, Ears, Nose, Throat and Larynx organ system
Prior diagnosis of malignancy, unless:
a. the malignancy has been treated with a curative intent and there is no evidence of recurrence or
b. in remission without treatment for greater than or equal to 2 years prior to study enrolment
Previous adverse reaction to any of the trial drug/s
Previous severe allergic or anaphylactic reaction to monoclonal antibody therapy
Vaccination with live vaccines within 28 days prior to start of treatment
Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Participation in other therapeutic studies in the last 28 days except for studies with a non-medical intervention. Documented evidence of receiving placebo will be required.
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalisation (relating to the completion of the course of antibiotics, except if for tumour fever) within 4 weeks prior to the start of Cycle 1
Positive test results for hepatitis C infection:
a. Positive Hepatitis C virus [HCV] antibody serology testing. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Hepatitis B infection defined as positive hepatitis B virus surface antigen (HBsAg) serology or hepatitis B core antibody (HBcAb). Known history of human immunodeficiency virus (HIV) seropositive status
Positive test results for human T-lymphotropic virus 1 (HTLV 1):
a. HTLV testing is required in participants from endemic countries (Japan, countries in the Caribbean basin, South America, Central America, sub Saharan Africa, and Melanesia)
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.