Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Stopped early · Phase 2
Conditions studied: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
In brief
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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
- NCT02044822
- Run by
- Gilead Sciences
- People needed
- 102
- Starts
- 2014-08-06
- Expected to finish
- 2016-05-17
- Last updated by the study team
- 2018-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Innovative Clinical Research Institute — Whittier, California, United States
- Rocky Mountain Cancer Centers — Boulder, Colorado, United States
- The University of Chicago Medicine — Chicago, Illinois, United States
- Illinois Cancer Specialists — Niles, Illinois, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Duke University — Durham, North Carolina, United States
- GHS Cancer Institute — Greenville, North Carolina, United States
- Compass Oncology — Portland, Oregon, United States
- Willamette Valley Cancer Center and Research Institute — Springfield, Oregon, United States
- Hospital of the University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
- St Vincent's Hospital, Sydney — Darlinghurst, New South Wales, Australia
- St George Hospital — Kogarah, New South Wales, Australia
- Icon Cancer Foundation — South Brisbane, Queensland, Australia
- St Vincent's Hospital, Melbourne — Fitzroy, Victoria, Australia
- Liverpool Hospital — Liverpool, Australia
- Innsbruck University Hospital, Inner Medicine, — Innsbruck, Austria
- Univ. Klinik für Innere Medizin III LKH — Salzburg, Austria
- Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie — Vienna, Austria
- AZ Sint-Jan AV Brugge-Oostende — Bruges, Belgium
- University Hospital Leuven — Leuven, Belgium
- University Hospital — Brno, Czechia
- Faculty Hospital Hradec Kralove — Hradec Králové, Czechia
- Hemato-Onkologicka Klinika Fn — Olomuc, Czechia
- Faculty hospital Ostrava — Ostrava-Poruba, Czechia
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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