A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)

An Open-label, Multicentre, Nonrandomized, Dose-escalating Phase I/II Study, With a Randomized Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease.

The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).

It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.

Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.

Inclusion Criteria:

• Adult patients, >=18 years of age;
• Phase 1 only: CD20+ malignant disease (B-cell lymphoma or B-CLL);
• Phase 2 only: relapsed or refractory indolent NHL, relapsed or refractory aggressive NHL or relapsed or refractory B-CLL
• Have a clinical indication for treatment as determined by the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Life expectancy >12 weeks

Exclusion Criteria:

• Prior use of any investigational antibody therapy or other agent within 6 months of study start;
• Prior use of any anti-cancer vaccine;
• Prior use of standard anti-lymphoma/leukemia therapy or radiation therapy within 4 weeks of enrollment;
• Prior use of MabThera (rituximab) within 8 weeks of study entry;
• Prior administration of radioimmunotherapy 3 months prior to study entry;
• Central nervous system (CNS) lymphoma.