New hope for CLL patients: experimental drug LOXO-305 faces off against standard care

NCT ID NCT04666038

First seen May 04, 2026 · Last updated May 13, 2026 · Updated 2 times

Summary

This study compares a new oral drug, LOXO-305, to two standard treatment combinations (idelalisib plus rituximab or bendamustine plus rituximab) in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already been treated with a BTK inhibitor. The main goal is to see if LOXO-305 can delay cancer progression better than the standard options. About 238 participants will be followed for up to four years or longer.

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Contacts and locations

Locations

  • A.O.U. Citta' della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • A.O.U. Policlinico G.Rodolico - S. Marco

    Catania, 95123, Italy

  • A.O.U. di Modena

    Modena, 41124, Italy

  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

    Milan, 20162, Italy

  • ASST Spedali Civili - Università degli Studi

    Brescia, 25123, Italy

  • ASST-Monza -U.O Ematologia Adulti

    Monza (MB) -Settore E, Piano 2, 20900, Italy

  • AULSS8 Berica-Ospedale S.Bortolo

    Vicenza, Veneto, 36100, Italy

  • AZ Delta

    Roeselare, West Flanders, 8800, Belgium

  • AZ St-Elisabeth

    Herentals, 2200, Belgium

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

  • Academician I.P. Pavlov First St-Petersburg State Medical University

    Saint Petersburg, 197022, Russia

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830002, China

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ankara University Medicine Hospital

    Mamak, Ankara, Turkey (Türkiye)

  • Arizona Oncology Associates, P.C. - HOPE

    Tucson, Arizona, 85711, United States

  • Arnett Cancer Center

    Lafayette, Indiana, 47904, United States

  • Ascension St. John Hospital

    Grosse Pointe Woods, Michigan, 48236, United States

  • Az. Osp. "Card G Panico"

    Tricase, 4 - 73039, Italy

  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15100, Italy

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, 88100, Italy

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI, 56126, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34125, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Beaumont Hospital, Dublin

    Dublin, DUBLIN 9, Ireland

  • Beijing Hospital

    Beijing, 100730, China

  • Blood Institute of the Chinese Academy of Medical science

    Tianjin, 300020, China

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486, United States

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234, United States

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

    Omsk, Omsk Oblast, 644013, Russia

  • CHD Vendee

    La Roche-sur-Yon, La Roche Sur Yon, 85000, France

  • CHR Verviers-Onco

    Verviers, Liege, 4800, Belgium

  • CHRU De Tours

    Tours, Tours Cedex 9, 37044, France

  • CHRU de Brest - Hôpital Morvan

    Brest, 29609, France

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, Cedex 09, 38043, France

  • California Research Institute

    Los Angeles, California, 90027, United States

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cancer Center Office of Clinical Research

    New Orleans, Louisiana, 70112, United States

  • Cancer Specialists of North Florida -St Augustine

    Jacksonville, Florida, 32256, United States

  • Carmel Hospital

    Haifa, Ḥeifā, 3436212, Israel

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732, United States

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Cedex, 69495, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

    Rouen, Seine-Maritime, 76038, France

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Ch Perpignan

    Perpignan, 66046, France

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, (r.o.c.), Taiwan, 33342, Taiwan

  • Charité Campus Virchow-Klinikum

    Berlin, 12203, Germany

  • China Medical University Hospital

    Taichung, Taichung, 40447, Taiwan

  • Chu Nimes/Institut De Cancerologie Du Gard

    Nîmes, Nimes, 30900, France

  • Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale

    Bellinzona, Svizzera, 6500, Switzerland

  • Clinical Research Alliance, Inc.

    Westbury, New York, 11590, United States

  • Clinique Saint Pierre Ottignies

    Ottignies, 1340, Belgium

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Complejo Hospitalario Universitario de Santiago de Compostel

    Santiago de Compostela, La Coruna, 15706, Spain

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb

    Zagreb, Croatia

  • Dokuz Eylul University Faculty of Medicine

    Izmir, 35330, Turkey (Türkiye)

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Erciyes University Faculty of Medicine

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Fakultni nemocnice Brno

    Brno, 62500, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency

    Saint Petersburg, 191024, Russia

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Gachon University Gil Hospital

    Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, South Korea

  • Gansu Province Cancer Hospital

    Lanzhou, Gansu, 730050, China

  • Gazi University Faculty of Medicine

    Ankara, Yenimahalle, 06560, Turkey (Türkiye)

  • GenesisCare Cambridge

    Newmarket, CB8 7XN, United Kingdom

  • Gleneagles Medical Centre

    Singapore, Central Singapore, 258499, Singapore

  • Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • Groupe Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Hainan Province People's Hospital

    Haikou, Hainan, 570100, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Saint Vincent De Paul

    Lille, 59020, France

  • Hospital AVICENNE

    Bobigny, Cedex, 93 009, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Planta Baja, 28007, Spain

  • Hospital General de Albacete

    Albacete, 02006, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, 10003, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Infanta Leonor-INTERNAL MED

    Madrid, 28031, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques De Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Alava

    Vitoria-Gasteiz, 01005, Spain

  • Hospital Universitario de Toledo

    Toledo, Castille-La Mancha, 45004, Spain

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714, United States

  • Ingham Institute of Medical Research

    Liverpool, New South Wales, NSW2170, Australia

  • Inje Univ Busan Paik Hospital

    Busan, 47392, South Korea

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028, Italy

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Viale Orazio Flacco, Bari, 70124, Italy

  • Istanbul University Istanbul Medicine Faculty

    Faith, Istanbul, Turkey (Türkiye)

  • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

    Perugia, 06132, Italy

  • JCHO Kyushu Hospital

    Fukoka-ken, 806 8501, Japan

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550, Japan

  • Kindai University Hospital

    Osaka Sayama-shi, Osaka, 589 8511, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Laniado Medical Center

    Netanya, 4244916, Israel

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, Schleswig-Holstein, 23562, Germany

  • Mater Misericordiae Hospital

    Dublin, Ireland

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713, United States

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Mercy Health-Paducah Medical Oncology and Hematology

    Paducah, Kentucky, 42003, United States

  • Milton Keynes University Hospital

    Milton Keynes, MK6 5LD, United Kingdom

  • Minnesota Oncology/Hematology PA

    Saint Paul, Minnesota, 55102, United States

  • Mitchell Cancer Institute -University of South Alabama

    Mobile, Alabama, 36604, United States

  • München Klinik Schwabing

    Koelner Platz 1, München, 80804, Germany

  • NHO Sendai Medical Center

    Sendai, Miyagi, 983-8520, Japan

  • NTT Medical Center Tokyo

    Shinagawa-Ku, Tokyo, 141-8625, Japan

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • Nebraska Hematology-Oncology

    Lincoln, Nebraska, 68506, United States

  • New Jersey Center for Cancer Research

    Brick, New Jersey, 08724, United States

  • Norfolk and Norwich Hospital

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu

    Wałbrzych, 58-309, Poland

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncology Dispensary #2 of Krasnodar Region

    Sochi, 354057, Russia

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45236, United States

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Roanoke, Virginia, 24014, United States

  • Oncology-Hematology Associates of West Broward

    Tamarac, Florida, 33321, United States

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708, United States

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020, Austria

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Ospedale Papardo

    Messina, 98158, Italy

  • Ospedale Policlinico Giambattista Rossi, Borgo Roma

    Verona, 37134, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, 48020, Italy

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304, United States

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Pole Regionalde Cancérologie(CHU de Poitiers)

    Politiers, Politiers, 86021, France

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Pratia Onkologia Katowice

    Katowice, 40519, Poland

  • Princess Margaret Hospital (Ontario)

    Toronto, Ontario, M5G 1Z5, Canada

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi, 49241, South Korea

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Rabin Medical Center

    Petah Tikva, Central District, Israel

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012, United States

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106, United States

  • Saitama Medical Center

    Kawagoe, Saitama, 350-8550, Japan

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, 200025, China

  • Singleton Hospital

    Swansea, SA2 8QA, United Kingdom

  • Soroka Medical Center

    Beersheba, 8457108, Israel

  • Southern Cancer Center, P.C.

    Daphne, Alabama, 36526, United States

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515, China

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • St James's Hosptial

    Dublin, D08 NHY1, Ireland

  • St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St Johns Hospital at Howden

    Livingston, West Lothian, EH54 6PP, United Kingdom

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000, China

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza

    Brzozów, 36-200, Poland

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii

    Bydgoszcz, 85-168, Poland

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, Pomeranian Voivodeship, 81-519, Poland

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106, United States

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231, United States

  • Texas Oncology - McAllen

    McAllen, Texas, 78503, United States

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230, United States

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240, United States

  • Texas Oncology Cancer Center

    Austin, Texas, 78705, United States

  • Texas Oncology Fort Worth

    Fort Worth, Texas, 76104, United States

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006, China

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Catholic University of Korea-Seoul St. Mary's Hospital

    Seocho-Gu, Seoul, 06591, South Korea

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The St. George Hospital

    Kogarah, New South Wales, 2217, Australia

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, China

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokai University Hospital- Isehara Campus

    Isehara, Kanagawa, 259-1143, Japan

  • Tri-Service General Hospital

    Taipei City, Taipei, 114, Taiwan

  • Uniklinik Köln

    Kerpener, Köln, 50937, Germany

  • Uniklinikum Salzburg

    Salzburg, Osterreich, 5020, Austria

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University College London Hospitals

    London, Greater London, WC1E 6HX, United Kingdom

  • University Hospital Split

    Split, 21000, Croatia

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40563, United States

  • University of Pecs 1st. Internalmedicin Clinic Dept

    Pécs, 7624, Hungary

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik

    Langenbeckstraße 1, Mainz, D- 55131, Germany

  • Uniwersytecki Szpital Kliniczny Klinika

    Wroclaw, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • VITAZ

    Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

  • WellStar Health System

    Marietta, Georgia, 30060, United States

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU, United Kingdom

  • Westmead Hospital

    Wentworthville, New South Wales, 2145, Australia

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

  • Wojewodzki Szpital Specjalistyczny

    Iwaszkiewicza 5, Legnica, 59-220, Poland

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, 93510, Poland

  • Xuanwu Hospital Capital Medical University

    Xicheng District, Beijing Municipality, 100053, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang Provincial Taizhou Hospital

    Linhai, Zhejiang, 317000, China

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