At a glance
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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
In Brief
A Phase 1 clinical trial evaluating Idelalisib, Rituximab, and 7 other interventions for Indolent Non-Hodgkin's Lymphoma and 2 related conditions. Completed, enrolled 241 participants across 11 sites.
Detailed 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).
Study Details
Timeline
Interventions
Idelalisib tablet administered orally
Rituximab administered intravenously
Bendamustine administered intravenously
Ofatumumab administered intravenously
Fludarabine administered orally
Everolimus administered orally twice daily until disease progression
Bortezomib administered as a subcutaneous injection
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.
Lenalidomide administered orally