Phase 2
Completed N=175
GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00576758 ↗Enrolled (actual)
175
Serious AEs
15.0%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Overall Response At the End of Induction Period — 33.3; 44.6 Percentage of participants — p=0.1587
Summary
This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101 (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response At the End of Induction Period |
33.3; 44.6 | 0.1587 |
| SECONDARY Percentage of Participants With Complete Response at the End of the Induction Period |
5.3; 12.2 | — |
| SECONDARY Percentage of Participants With Partial Response (PR) at the End of the Induction Period |
28.0; 32.4 | — |
| SECONDARY Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment |
22.7; 41.9; 41.3; 24.3; 26.7; 21.6 | — |
| SECONDARY Number of Participants With Improved Overall Response During the Extended Treatment Period |
31; 32 | — |
| SECONDARY Progression-Free Survival (PFS) |
772; 536 | — |
| SECONDARY Percentage of Participants With Progression-Free Survival (PFS) Events |
57.7; 51.4 | — |
| SECONDARY Event Free Survival |
472.0; 472.0 | — |
| SECONDARY Percentage of Participants With Event Free Survival (EFS) Events |
64.0; 63.5 | — |
| SECONDARY Duration of Response |
809; NA | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2) |
41.0 | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax) |
292; 448; 561; 692 | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast) |
23400 | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss) |
308 | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss) |
14.6 | — |
| SECONDARY Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau) |
4370 | — |
| SECONDARY Obinutuzumab Trough Serum Concentration (Ctrough) |
154; 301; 418 | — |
| SECONDARY Number of Participants With Peripheral Blood B-Cell Depletion |
80; 82 | — |
| SECONDARY Number of Participants With Peripheral Blood B-Cell Recovery |
0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
74; 83; 17; 21 | — |
| SECONDARY Number of Participants With Infusion Related Reactions |
44; 70 | — |
| SECONDARY Number of Participants With Human Anti-Chimeric Antibodies (HACA) |
1 | — |
| SECONDARY Number of Participants With Human Anti-Human Antibodies (HAHA) |
— | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age
- relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
- documented history of response of >/= 6 months duration from last rituximab-containing regimen
- clinical indication for treatment as determined by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
- prior use of any investigational monoclonal antibody within 6 months of study start
- prior use of any anti-cancer vaccine
- prior use of rituximab within 8 weeks of study entry
- radioimmunotherapy within 3 months prior to study entry
- Central Nervous System (CNS) lymphoma or evidence of transformation to high-grade or diffuse large B-cell lymphoma
Data sourced from ClinicalTrials.gov (NCT00576758). 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. Informational only — not medical advice.