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Brief Title: A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma
Official Title: A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)
Study ID: NCT04038359
Brief Summary: This study will examine the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Detailed Description: This is a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have received at least 1 prior systemic therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Cancer Specialists - Fort Myers, Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute - Lecanto, Lecanto, Florida, United States
Mid-Florida Cancer Centers, Orange City, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Tennessee Oncology, Nashville, Tennessee, United States
FN Hradec Kralove, Hradec Králové, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Universitaetsklinikum Bonn AöR, Bonn, , Germany
Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Forli, Italy
IEO - Istituto Europeo di Oncologia, IRCCS, Milano, , Italy
AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Samsung Medical Center - Hematology-Oncology, Seoul, , Korea, Republic of
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Slupsk, Pomorskie, Poland
Pratia Onkologia Katowice, Katowice, , Poland
Centrum Medyczne Pratia Poznan, Skórzewo, , Poland
State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City, Moscow, , Russian Federation
City Clinical Hospital n.a. Botkin, Moscow, , Russian Federation
First Saint-Petersburg State Medical University n.a. I.P. Pavlov, Sankt-Peterburg, , Russian Federation
NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit, Glasgow, , United Kingdom
Royal Liverpool Hospital [Hematology/Transfusion Medicine], Liverpool, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom