Trials / Completed
CompletedNCT01088048
Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idelalisib | Idelalisib tablet administered orally |
| DRUG | Rituximab | Rituximab administered intravenously |
| DRUG | Bendamustine | Bendamustine administered intravenously |
| DRUG | Ofatumumab | Ofatumumab administered intravenously |
| DRUG | Fludarabine | Fludarabine administered orally |
| DRUG | Everolimus | Everolimus administered orally twice daily until disease progression |
| DRUG | Bortezomib | Bortezomib administered as a subcutaneous injection |
| DRUG | Chlorambucil | Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens. |
| DRUG | Lenalidomide | Lenalidomide administered orally |
Timeline
- Start date
- 2010-03-25
- Primary completion
- 2015-04-28
- Completion
- 2015-04-28
- First posted
- 2010-03-17
- Last updated
- 2021-03-18
- Results posted
- 2021-03-18
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01088048. Inclusion in this directory is not an endorsement.