Phase 2 N=134 Treatment

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

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00517530 ↗

Enrolled (actual)

134

Serious AEs

34.3%

Results posted

Sep 2015

Primary outcome: Primary: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study — 0; 0; 0; 0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Obinutuzumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study	0; 0; 0; 0; 0; 0	—
PRIMARY Percentage of Participants With Best Overall Response in Phase II of the Study	33.3; 63.6; 23.8; 36.8; 30.0	—
SECONDARY Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study	5.6; 13.6; 9.5; 15.8; 5.0; 5.6	—
SECONDARY Percentage of Participants With Partial Response (PR) in Phase II of the Study	22.2; 40.9; 9.5; 21.1; 25.0	—
SECONDARY Progression-free Survival (PFS) in Phase II of the Study	182; 361; 78; 83; 324	—
SECONDARY Duration of Response by Disease Type in Phase II of the Study	523; 298; 272.5	—
SECONDARY Participants With Event-Free Survival (EFS) in Phase II of the Study	5; 6; 2; 3; 4	—
SECONDARY Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study	0; 0; 0; 0; 3; 0	—
SECONDARY Percentage of Retreated Participants With Response	62; 23; 38	—
SECONDARY Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants	134; 234; 307; NA; NA; 367	—
SECONDARY Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study	459; 993; 1057; 146	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00517530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.