Overview

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

Status:
Completed
Trial end date:
2017-08-23
Target enrollment:
0
Participant gender:
All
Summary
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 (1000 mg intravenous (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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborators:
Genentech, Inc.
German CLL Study Group
Treatments:
Chlorambucil
Obinutuzumab
Rituximab
Criteria
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