Trials / Terminated
TerminatedNCT02391545
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
Detailed description
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL. The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duvelisib | PI3K Inhibitor |
| DRUG | Rituximab | monoclonal antibody |
| DRUG | Obinutuzumab | monoclonal antibody |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2017-01-17
- Completion
- 2017-05-01
- First posted
- 2015-03-18
- Last updated
- 2023-09-28
- Results posted
- 2019-01-08
Locations
21 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02391545. Inclusion in this directory is not an endorsement.