Trials / Completed
CompletedNCT03276468
Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas
A Phase II Trial Evaluating Combination of Atezolizumab, With Venetoclax and Obinutuzumab for Relapsed/Refractory Lymphomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- The Lymphoma Academic Research Organisation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: * relapsed/refractory follicular lymphoma (FL) patients * relapsed/refractory aggressive (DLBCL) lymphoma patients * relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT)
Conditions
- Follicular Lymphoma
- Diffuse Large B Cell Lymphoma
- Marginal Zone Lymphoma
- Mucosa Associated Lymphoid Tissue
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | 1200 mg on day 2 of each 21-day cycle during 18 months (24 cycles) |
| DRUG | Obinutuzumab | 1000 mg on day 1, day 8 and day 15 of cycle 1 and each day 1 from cycle 2 to cycle 8 |
| DRUG | Venetoclax | 800 mg/d from day 8 of cycle 1, every day during 18 months. For MZL patients wiht lymphocytes\>5 g/l : 50 mg/day: week 1 100mg/day: week 2 200mg/day: week 3 400mg/day: week 4 800mg/day: from week 5 |
Timeline
- Start date
- 2018-02-12
- Primary completion
- 2019-09-19
- Completion
- 2022-08-24
- First posted
- 2017-09-08
- Last updated
- 2023-01-10
Locations
25 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03276468. Inclusion in this directory is not an endorsement.