Clinical trial NCT01300247 (phase 1, status: completed)
Conditions: lymphocytic leukemia, chronic
ICD codes: C91.11, C91.12, C91.10
Drugs: fludarabine, obinutuzumab, bendamustine, cyclophosphamide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CD20-positive B-CLL

          -  Rai Stage III/IV or Binet Stage C disease

          -  Rai Stage I/II or Binet Stage B disease that requires treatment

          -  Adequate baseline bone marrow function, unless there is clear evidence of extensive
             bone marrow involvement with tumor infiltration, myelodysplasia, or hypocellularity

          -  No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Life expectancy of greater than (>) 6 months

        Exclusion Criteria:

          -  Treatment with any other investigational agent or participation in another clinical
             trial within 28 days prior to the start of Cycle 1

          -  Transformation of CLL to aggressive B-cell malignancy

          -  Creatinine clearance less than equal to (<=) 60 milliliters per minute (mL/min),
             calculated according to the formula of Cockcroft and Gault

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the
             upper limit of normal (ULN)

          -  Total bilirubin greater than equal to (>=) 3 x ULN

          -  History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

          -  History of sensitivity to mannitol (if bendamustine is to be administered)

          -  History of other malignancy that could affect compliance with the protocol or
             interpretation of results

          -  Evidence of significant, uncontrolled concomitant diseases that could affect
             compliance with the protocol or interpretation of results, including significant
             cardiovascular disease or pulmonary disease

          -  Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding
             fungal infections of nail beds) or any major episode of infection requiring treatment
             with IV antibiotics or hospitalization (related to the completion of the course of
             antibiotics) within 4 weeks before the start of Cycle 1

          -  Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for
             diagnosis

          -  Known infection with human immunodeficiency virus (HIV) seropositive status

          -  Presence of positive test results for hepatitis B (hepatitis B virus [HBV] surface
             antigen [HBsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C
             (hepatitis C virus [HCV] antibody serology testing). Participants with chronic HBV
             infection, occult HBV infection, or past HBV infection will be excluded. Participants
             who have received IV immunoglobulin within 3 months of enrollment and who are anti-HBc
             positive but HBV deoxyribonucleic acid (DNA) negative will be considered for inclusion
             on the study by the Medical Monitor on a case-by-case basis. Participants positive for
             HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV
             ribonucleic acid (RNA).

          -  Women who are pregnant or lactating

          -  Fertile men or women of childbearing potential unless 1) surgically sterile or 2)
             using an adequate measure of contraception such as oral contraceptives, intrauterine
             device, or barrier method of contraception in conjunction with spermicidal jelly

          -  Concurrent (or within 7 days prior to the first dose of study treatment) systemic
             corticosteroid use except low-dose corticosteroid therapy used to treat an illness
             other than lymphoma