Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Stopped early · Phase 2
Conditions studied: Follicular Lymphoma, Small Lymphocytic Lymphoma
In brief
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Key facts
- Study ID
- NCT02258529
- Run by
- Gilead Sciences
- People needed
- 10
- Starts
- 2015-09-14
- Expected to finish
- 2016-05-03
- Last updated by the study team
- 2019-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pacific Shores Medical Group — Long Beach, California, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- St. Agnes Hospital — Baltimore, Maryland, United States
- Prarie Lakes Health Care Systems, Inc. — Watertown, South Dakota, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.