Trials / Completed
CompletedNCT02956382
Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Georgetown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.
Detailed description
In vitro studies of ibrutinib and venetoclax have noted significant cytotoxicity and synergy in mantle cell lymphoma and chronic lymphocytic leukemia cell lines.Data have demonstrated synergy between the two agents in various other B-cell Non-Hodgkin Lymphoma (NHL) cell lines. The investigators theorize that the combination of ibrutinib and venetoclax will provide dual, yet unique, targeted inhibition for patients with follicular lymphoma, resulting in both significant efficacy and less nonspecific toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Ibrutinib is dispensed as a capsule. |
| DRUG | Venetoclax | Venetoclax is dispensed as a tablet. |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2023-05-23
- Completion
- 2024-03-07
- First posted
- 2016-11-07
- Last updated
- 2025-07-18
- Results posted
- 2024-05-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02956382. Inclusion in this directory is not an endorsement.