CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of
 obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus
 chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic
 leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles
 of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles
 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv
 infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil
 alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression
 and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on
 clinicaltrials.gov because there are 3 separate primary analyses conducted at different
 time-points.

 -  BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab
 plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately.

 -  BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus
 chlorambucil (RClb) compared to chlorambucil (Clb) reported here.

 -  BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab
 plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported
 separately.
Inclusion Criteria:

 -  Adults >/=18 years

 -  Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic
 Lymphoma (B-CLL)

 -  Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according
 to the National Cancer Institute (NCI) criteria

 -  Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70
 ml/min

 Exclusion Criteria:

 -  Prior CLL therapy

 -  Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
 transformation)

 -  History of other malignancy unless the malignancy has been in remission without
 treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the
 cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate
 cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy
 alone

 -  Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus
 (HTLV) testing

 -  Patients with active infection requiring systemic treatment