NCT02987400

Combination of Obinutuzumab and Venetoclax in Relapsed or Refractory DLBCL

Phase II Single-arm "Window-of-opportunity" Study of a Combination of Obinutuzumab (GA-101) and Venetoclax (ABT-199) in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical activity and tolerability of a combination of obinutuzumab plus venetoclax in patients with relapsed or refractory diffuse large B-cell lymphoma.

Detailed description

The study will have a 6 patient run-in phase to determine safety and to adjust treatment. Once the sixth patient has completed 21 days of treatment, withdrawn due to toxicity, or died, a formal review will be undertaken by the sponsor (AGMT). Enrolment will be halted until review is completed. If one (1) treatment related death is reported or three (3) or more patients experience CTC grade 4 events other than neutropenia, anemia, or thrombocytopenia, the study will be stopped for further recruitment. If the stopping criteria are not met, enrollment will be continued. A futility analysis will be conducted when the first 10 patients have been evaluated for response: If at least 2 patients had an objective response (CR or PR), the study will be continued. The combination treatment will be repeated for up to 3 cycles. The first response assessment (including PET-CT) will be performed after the first cycle of obinutuzumab-venetoclax and patients with at least stable disease (SD) or better will be given another 2 cycles of therapy and then have assessment after a total of 3 cycles. Patients with complete or partial remission (CR, PR) after 3 cycles of therapy will either go on to transplant or receive 9 further cycles of the combination therapy (if transplant ineligible). Patients with progressive disease at any time-point or stable disease after 3 cycles will be taken off study.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Venetoclax	3 cycles followed by 9 cycles consolidation if not transplant eligible
DRUG	Obinutuzumab	3 cycles followed by 9 cycles consolidation if not transplant eligible

Timeline

• Start date: 2017-01-04
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2016-12-09
• Last updated: 2022-02-16

Locations

6 sites across 1 country: Austria