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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Obinutuzumab

Criteria

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.