Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-321)

April 24, 2024 updated by: Loxo Oncology, Inc.

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Kogarah, New South Wales, Australia, 2217
        • The St. George Hospital
      • Liverpool, New South Wales, Australia, NSW2170
        • Ingham Institute of Medical Research
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Ordensklinikum Linz Gmbh Elisabethinen
    • Osterreich
      • Salzburg, Osterreich, Austria, 5020
        • Uniklinikum Salzburg
  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Haine-Saint-Paul, Belgium, 7100
        • Groupe Jolimont
      • Herentals, Belgium, 2200
        • AZ St-Elisabeth
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre Ottignies
    • Liege
      • Verviers, Liege, Belgium, 4800
        • CHR Verviers-Onco
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • VITAZ
    • West Flanders
      • Roeselare, West Flanders, Belgium, 8800
        • AZ Delta
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Center
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Hospital (Ontario)
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Tianjin, China, 300020
        • Blood Institute of the Chinese Academy of Medical science
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University first hospital
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Xicheng District, Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Gansu Province Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital
    • Hainan
      • Haikou, Hainan, China, 570100
        • Hainan Province People's Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of NanChang University
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830002
        • Affiliated Tumor Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Linhai, Zhejiang, China, 317000
        • Zhejiang Provincial Taizhou Hospital
  • Croatia
      • Split, Croatia, 21000
        • University Hospital Split
      • Zagreb, Croatia
        • Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni Nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Praha 2, Czechia, 12808
        • Vseobecna Fakultni Nemocnice V Praze
  • France
      • Bayonne, France, 64109
        • Centre Hospitalier de la Cote Basque
      • Bordeaux, France, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
      • Brest cedex, France, 29609
        • CHRU de Brest - Hôpital Morvan
      • Le Mans, France, 72000
        • Centre Hospitalier Du Mans
      • Lille cedex, France, 59020
        • Hôpital Saint Vincent de Paul
      • Perpignan, France, 66046
        • Ch Perpignan
      • Politiers, France, 86021
        • Pole Regionalde Cancérologie(CHU de Poitiers)
    • Cedex
      • Bobigny, Cedex, France, 93 009
        • Hospital AVICENNE
      • Pierre Benite, Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
    • Cedex 09
      • Grenoble, Cedex 09, France, 38043
        • CHU De Grenoble Hopital Albert Michallon
    • La Roche Sur Yon
      • La Roche-sur-Yon, La Roche Sur Yon, France, 85000
        • CHD Vendee
    • Nimes
      • Nîmes, Nimes, France, 30900
        • Chu Nimes/Institut De Cancerologie Du Gard
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
    • Tours Cedex 9
      • Tours, Tours Cedex 9, France, 37044
        • CHRU De Tours
  • Germany
      • Berlin, Germany, 12203
        • Charité Campus Virchow-Klinikum
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Köln
      • Kerpener, Köln, Germany, 50937
        • Uniklinik Köln
    • Mainz
      • Langenbeckstraße 1, Mainz, Germany, D- 55131
        • Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
    • München
      • Koelner Platz 1, München, Germany, 80804
        • München Klinik Schwabing
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Lübecker Onkologische Schwerpunktpraxis
  • Hungary
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Nyiregyhaza, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Pecs, Hungary, 7624
        • University of Pecs 1st. Internalmedicin Clinic Dept
  • Ireland
      • Dublin, Ireland, DUBLIN 9
        • Beaumont Hospital, Dublin
      • Dublin 7, Ireland
        • Mater Misericordiae Hospital
      • Dublin 8, Ireland, D08 NHY1
        • St James's Hosptial
  • Israel
      • Beer Sheva, Israel, 8457108
        • Soroka Medical Center
      • Netanya, Israel, 4244916
        • Laniado Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • HaMerkaz
      • Petah Tikva, HaMerkaz, Israel
        • Rabin Medical Center
    • Ḥeifā
      • Haifa, Ḥeifā, Israel, 3436212
        • Carmel Hospital
  • Italy
      • Alessandria, Italy, 15100
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Italy, 25123
        • ASST Spedali Civili - Università degli Studi
      • Catania, Italy, 95123
        • A.O.U. Policlinico G.Rodolico - S. Marco
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Pugliese Ciaccio
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Messina, Italy, 98158
        • Ospedale Papardo
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Modena, Italy, 41124
        • A.O.U. di Modena
      • Pavia, Italy, 27100
        • Fondazione Irccs Policlinico San Matteo
      • Perugia, Italy, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Italy, 48020
        • Ospedale Santa Maria delle Croci
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Torino, Italy, 10126
        • A.O.U. Citta' della Salute e della Scienza di Torino
      • Tricase, Italy, 4 - 73039
        • Az. Osp. "Card G Panico"
      • Trieste, Italy, 34125
        • Azienda Sanitaria Universitaria Giuliano Isontina
      • Verona, Italy, 37134
        • Ospedale Policlinico Giambattista Rossi, Borgo Roma
    • Bari
      • Viale Orazio Flacco, Bari, Italy, 70124
        • Irccs Istituto Tumori Giovanni Paolo Ii
    • PI
      • Pisa, PI, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
    • Piano 2
      • Monza (MB) -Settore E, Piano 2, Italy, 20900
        • ASST-Monza -U.O Ematologia Adulti
    • Potenza
      • Rionero In Vulture, Potenza, Italy, 85028
        • Irccs Crob
    • Veneto
      • Vicenza, Veneto, Italy, 36100
        • AULSS8 Berica-Ospedale S.Bortolo
  • Japan
      • Fukoka-ken, Japan, 806 8501
        • JCHO Kyushu Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Gifu
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1143
        • Tokai University Hospital- Isehara Campus
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan, 983-8520
        • NHO Sendai Medical Center
    • Osaka
      • Osaka Sayama-shi, Osaka, Japan, 589 8511
        • Kindai University Hospital
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical Center
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
      • Shinagawa-Ku, Tokyo, Japan, 141-8625
        • Ntt Medical Center Tokyo
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Gachon University Gil Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49241
        • Pusan National University Hospital
    • Seoul
      • Seocho-Gu, Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
      • Katowice, Poland, 40519
        • Pratia Onkologia Katowice
      • Krakow, Poland, 30-510
        • Pratia MCM Krakow
      • Walbrzych, Poland, 58-309
        • Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
      • Warszawa, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
      • Wrocław, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
      • Łódź, Poland, 93510
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
    • Legnica
      • Iwaszkiewicza 5, Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-081
        • Centrum Onkologii Ziemi Lubelskiej
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Pomorskie, Poland, 81-519
        • Szpitale Pomorskie Sp. z o. o.
  • Russian Federation
      • Saint Petersburg, Russian Federation, 191024
        • Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
      • Saint Petersburg, Russian Federation, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
      • Sochi, Russian Federation, 354057
        • Oncology Dispensary #2 of Krasnodar Region
    • Omskaya Oblast'
      • Omsk, Omskaya Oblast', Russian Federation, 644013
        • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 258499
        • Gleneagles Medical Centre
  • Spain
      • Albacete, Spain, 02006
        • Hospital General de Albacete
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Caceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor-INTERNAL MED
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Vitoria, Spain, 01005
        • Hospital Universitario de Alava
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Hospital Duran I Reynals
    • Castilla La Mancha
      • Toledo, Castilla La Mancha, Spain, 45004
        • Hospital Universitario de Toledo
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago de Compostel
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Hospital Universitario Ramon y Cajal
    • Planta Baja
      • Madrid, Planta Baja, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
  • Switzerland
    • Svizzera
      • Bellinzona, Svizzera, Switzerland, 6500
        • Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
  • Taiwan
      • Taipei City, Taiwan, 112201
        • Taipei Veterans General Hospital
      • Taoyuan, (r.o.c.), Taiwan, 33342
        • Chang Gung Memorial Hospital - Linkou
    • Taichung
      • Taichung City, Taichung, Taiwan, 40447
        • China Medical University Hospital
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Tri-Service General Hospital
  • Turkey
      • Izmir, Turkey, 35100
        • Ege University Medical Faculty
      • Izmir, Turkey, 35330
        • Dokuz Eylul University Faculty of Medicine
    • Ankara
      • Mamak, Ankara, Turkey
        • Ankara University Medicine Hospital
    • Istanbul
      • Faith, Istanbul, Turkey
        • Istanbul University Istanbul Medicine Faculty
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38039
        • Erciyes University Faculty of Medicine
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06560
        • Gazi University Faculty of Medicine
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • Milton Keynes, United Kingdom, MK6 5LD
        • Milton Keynes University Hospital
      • Newmarket, United Kingdom, CB8 7XN
        • GenesisCare Cambridge
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • The Royal Cornwall Hospital
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
    • Greater London
      • London, Greater London, United Kingdom, WC1E 6HX
        • University College London Hospitals
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich Hospital
    • Sa2 8qa
      • Swansea, Sa2 8qa, United Kingdom
        • Singleton Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • West Lothian
      • Livingston, West Lothian, United Kingdom, EH54 6PP
        • St Johns Hospital at Howden
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, P.C.
      • Mobile, Alabama, United States, 36604
        • Mitchell Cancer Institute -University of South Alabama
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates, P.C. - HOPE
    • California
      • Fountain Valley, California, United States, 92708
        • Orange Coast Memorial Medical Center
      • Los Angeles, California, United States, 90027
        • California Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida -St Augustine
      • Tamarac, Florida, United States, 33321
        • Oncology-Hematology Associates of West Broward
    • Georgia
      • Marietta, Georgia, United States, 30060
        • WellStar Health System
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists-Niles
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40563
        • University of Kentucky Markey Cancer Center
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
      • Paducah, Kentucky, United States, 42003
        • Mercy Health-Paducah Medical Oncology and Hematology
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Cancer Center Office of Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Comprehensive Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Ascension St. John Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Minnesota Oncology/Hematology PA
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • New Jersey Center for Cancer Research
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Westbury, New York, United States, 11590
        • Clinical Research Alliance, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care Inc
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood and Cancer Care Associates
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Austin, Texas, United States, 78705
        • Texas Oncology Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology Fort Worth
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • San Antonio, Texas, United States, 78240
        • Texas Oncology - San Antonio Medical Center
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia Inc
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
  • Previously treated with a covalent BTK inhibitor.
  • Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
  • Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
  • Platelets ≥ 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded.
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Estimated creatinine clearance of ≥ 30 mL/min.

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment.
  • Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
  • Ongoing drug-induced liver injury.
  • Active uncontrolled auto-immune cytopenia.
  • Significant cardiovascular disease.
  • History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
  • Active hepatitis B or hepatitis C.
  • Known active cytomegalovirus (CMV) infection.
  • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
  • Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
  • Clinically significant active malabsorption syndrome or inflammatory bowel disease
  • Prior exposure to non-covalent (reversible) BTK inhibitor.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers.
  • Vaccination with a live vaccine within 28 days prior to randomization.

  • Patients with the following hypersensitivity:

    1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
    2. Prior significant hypersensitivity to rituximab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (LOXO-305)
Orally
Drug: LOXO-305
Oral LOXO-305
Other Names:
  • Pirtobrutinib
Active Comparator: Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])
Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).
Drug: Rituximab
IV
Other Names:
  • Rituxan, MabThera, Truxima
Drug: Idelalisib
Oral
Other Names:
  • Zydelig
Drug: Bendamustine
IV
Other Names:
  • Treanda, Treakisym, Ribomustin, Levact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)
Time Frame: Up to approximately 36 months
Assessed per iwCLL 2018
Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
Time Frame: Up to approximately 36 months
Assessed per iwCLL 2018
Up to approximately 36 months
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS)
Time Frame: Up to approximately 36 months
Assessed by survival
Up to approximately 36 months
To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT)
Time Frame: Up to approximately 36 months
Defined as time from randomization to next systemic anticancer therapy for CLL/SLL
Up to approximately 36 months
Time to worsening (TTW) of CLL/SLL related symptoms
Time Frame: Up to approximately 36 months
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms
Up to approximately 36 months
Time to worsening (TTW) of physical function
Time Frame: Up to approximately 36 months
Using the 5 physical function items identified from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) questionnaire (also known as the EORTC IL 19 questionnaire), physical function will be measured. The range of raw scores for these items could be from 0-20 with the highest score indicating worst function.
Up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Marisa Hill, MD, Loxo Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOXO-BTK-20020
  • J2N-OX-JZNN (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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