AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3BRUIN CLL-321NCT04666038

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 3 study testing Pirtobrutinib, Idelalisib and Bendamustine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 232 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib, Idelalisib and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
232 sitesin 24 countries
Study dates
9 Mar 2021to May 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • AST and ALT ≤ 3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Estimated creatinine clearance of ≥ 30 mL/min.

Who cannot join

  • 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.
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  • 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:
  • 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.
  • Prior significant hypersensitivity to rituximab.

Trial locations and contacts

232 sites in 24 countries.

232 sites in 24 countries

United States46 sites

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Texas Oncology Cancer Center

    Austin, Texas, 78705

  • Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • New Jersey Center for Cancer Research

    Brick, New Jersey, 08724

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45236

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Southern Cancer Center, P.C.

    Daphne, Alabama, 36526

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Texas Oncology Fort Worth

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

  • Ascension St. John Hospital

    Grosse Pointe Woods, Michigan, 48236

  • Community Health Network

    Indianapolis, Indiana, 46250

  • Cancer Specialists of North Florida -St Augustine

    Jacksonville, Florida, 32256

  • Arnett Cancer Center

    Lafayette, Indiana, 47904

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40563

  • Nebraska Hematology-Oncology

    Lincoln, Nebraska, 68506

  • California Research Institute

    Los Angeles, California, 90027

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

  • WellStar Health System

    Marietta, Georgia, 30060

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Mitchell Cancer Institute -University of South Alabama

    Mobile, Alabama, 36604

  • Cancer Center Office of Clinical Research

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Mercy Health-Paducah Medical Oncology and Hematology

    Paducah, Kentucky, 42003

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Roanoke, Virginia, 24014

  • University of Rochester

    Rochester, New York, 14642

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732

  • Minnesota Oncology/Hematology PA

    Saint Paul, Minnesota, 55102

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Oncology-Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Arizona Oncology Associates, P.C. - HOPE

    Tucson, Arizona, 85711

  • Clinical Research Alliance, Inc.

    Westbury, New York, 11590

Other trials in United States

Italy25 sites

  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15100

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • ASST Spedali Civili - Università degli Studi

    Brescia, 25123

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

    Catania, 95123

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale Papardo

    Messina, 98158

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

    Milan, 20162

  • A.O.U. di Modena

    Modena, 41124

  • ASST-Monza -U.O Ematologia Adulti

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

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

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

    Perugia, 06132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI, 56126

  • Ospedale Santa Maria delle Croci

    Ravenna, 48020

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028

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

    Roma, 00168

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

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

    Torino, 10126

  • Az. Osp. "Card G Panico"

    Tricase, 4 - 73039

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34125

  • Ospedale Policlinico Giambattista Rossi, Borgo Roma

    Verona, 37134

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Viale Orazio Flacco, Bari, 70124

  • AULSS8 Berica-Ospedale S.Bortolo

    Vicenza, Veneto, 36100

Other trials in Italy

China20 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, 100730

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Hainan Province People's Hospital

    Haikou, Hainan, 570100

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Gansu Province Cancer Hospital

    Lanzhou, Gansu, 730050

  • Zhejiang Provincial Taizhou Hospital

    Linhai, Zhejiang, 317000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

  • Blood Institute of the Chinese Academy of Medical science

    Tianjin, 300020

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830002

  • Xuanwu Hospital Capital Medical University

    Xicheng District, Beijing Municipality, 100053

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Japan18 sites

  • JCHO Kyushu Hospital

    Fukoka-ken, 806 8501

  • Tokai University Hospital- Isehara Campus

    Isehara, Kanagawa, 259-1143

  • Saitama Medical Center

    Kawagoe, Saitama, 350-8550

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka University Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osaka Sayama-shi, Osaka, 589 8511

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • NHO Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • NTT Medical Center Tokyo

    Shinagawa-Ku, Tokyo, 141-8625

Other trials in Japan

Spain15 sites

  • Hospital General de Albacete

    Albacete, 02006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital General Universitario Gregorio Marañón

    Madrid, Planta Baja, 28007

  • Hospital Universitario Infanta Leonor-INTERNAL MED

    Madrid, 28031

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques De Valdecilla

    Santander, 39008

  • Complejo Hospitalario Universitario de Santiago de Compostel

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario de Toledo

    Toledo, Castille-La Mancha, 45004

  • Hospital Universitario de Alava

    Vitoria-Gasteiz, 01005

Other trials in Spain

France14 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • Hospital AVICENNE

    Bobigny, Cedex, 93 009

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

    Bordeaux, 33076

  • CHRU de Brest - Hôpital Morvan

    Brest, 29609

  • CHU De Grenoble Hopital Albert Michallon

    Grenoble, Cedex 09, 38043

  • CHD Vendee

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

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Hopital Saint Vincent De Paul

    Lille, 59020

  • Chu Nimes/Institut De Cancerologie Du Gard

    Nîmes, Nimes, 30900

  • Ch Perpignan

    Perpignan, 66046

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Cedex, 69495

  • Pole Regionalde Cancérologie(CHU de Poitiers)

    Politiers, Politiers, 86021

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

    Rouen, Seine-Maritime, 76038

  • CHRU De Tours

    Tours, Tours Cedex 9, 37044

Other trials in France

Poland13 sites

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

    Brzozów, 36-200

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

    Bydgoszcz, 85-168

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, Pomeranian Voivodeship, 81-519

  • Wojewodzki Szpital Specjalistyczny

    Iwaszkiewicza 5, Legnica, 59-220

  • Pratia Onkologia Katowice

    Katowice, 40519

  • Pratia MCM Krakow

    Krakow, 30-510

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, 93510

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, Lublin Voivodeship, 20-081

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

    Wałbrzych, 58-309

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

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

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny Klinika

    Wroclaw, 50-367

Other trials in Poland

United Kingdom13 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City, AB25 2ZN

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • St James's University Hospital

    Leeds, LS9 7TF

  • St Johns Hospital at Howden

    Livingston, West Lothian, EH54 6PP

  • University College London Hospitals

    London, Greater London, WC1E 6HX

  • Milton Keynes University Hospital

    Milton Keynes, MK6 5LD

  • GenesisCare Cambridge

    Newmarket, CB8 7XN

  • Norfolk and Norwich Hospital

    Norwich, Norfolk, NR4 7UY

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • Singleton Hospital

    Swansea, SA2 8QA

  • The Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Germany8 sites

  • Charité Campus Virchow-Klinikum

    Berlin, 12203

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Uniklinik Köln

    Kerpener, Köln, 50937

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • München Klinik Schwabing

    Koelner Platz 1, München, 80804

  • Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik

    Langenbeckstraße 1, Mainz, D- 55131

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, Schleswig-Holstein, 23562

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Australia7 sites

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • The St. George Hospital

    Kogarah, New South Wales, 2217

  • Ingham Institute of Medical Research

    Liverpool, New South Wales, NSW2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Belgium7 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Groupe Jolimont

    Haine-Saint-Paul, 7100

  • AZ St-Elisabeth

    Herentals, 2200

  • Clinique Saint Pierre Ottignies

    Ottignies, 1340

  • AZ Delta

    Roeselare, West Flanders, 8800

  • VITAZ

    Sint-Niklaas, Oost-Vlaanderen, B-9100

  • CHR Verviers-Onco

    Verviers, Liege, 4800

Other trials in Belgium

South Korea6 sites

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi, 49241

  • Inje Univ Busan Paik Hospital

    Busan, 47392

  • Gachon University Gil Hospital

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

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

    Seocho-Gu, Seoul, 06591

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Gazi University Faculty of Medicine

    Ankara, Yenimahalle, 06560

  • Istanbul University Istanbul Medicine Faculty

    Faith, Istanbul

  • Ege University Medical Faculty

    Izmir, 35100

  • Dokuz Eylul University Faculty of Medicine

    Izmir, 35330

  • Erciyes University Faculty of Medicine

    Kayseri, Melikgazi, 38039

  • Ankara University Medicine Hospital

    Mamak, Ankara

Other trials in Turkey (Türkiye)

Israel5 sites

  • Soroka Medical Center

    Beersheba, 8457108

  • Carmel Hospital

    Haifa, Ḥeifā, 3436212

  • Laniado Medical Center

    Netanya, 4244916

  • Rabin Medical Center

    Petah Tikva, Central District

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Canada4 sites

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Princess Margaret Hospital (Ontario)

    Toronto, Ontario, M5G 1Z5

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Hungary4 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • University of Pecs 1st. Internalmedicin Clinic Dept

    Pécs, 7624

Other trials in Hungary

Russia4 sites

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

    Omsk, Omsk Oblast, 644013

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

    Saint Petersburg, 191024

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

    Saint Petersburg, 197022

  • Oncology Dispensary #2 of Krasnodar Region

    Sochi, 354057

Other trials in Russia

Taiwan4 sites

  • China Medical University Hospital

    Taichung, Taichung, 40447

  • Taipei Veterans General Hospital

    Taipei, 112201

  • Tri-Service General Hospital

    Taipei City, Taipei, 114

  • Chang Gung Memorial Hospital - Linkou

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

Other trials in Taiwan

Austria3 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

  • Uniklinikum Salzburg

    Salzburg, Osterreich, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Ireland3 sites

  • St James's Hosptial

    Dublin, D08 NHY1

  • Beaumont Hospital, Dublin

    Dublin, DUBLIN 9

  • Mater Misericordiae Hospital

    Dublin

Other trials in Ireland

Croatia2 sites

  • University Hospital Split

    Split, 21000

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

    Zagreb

Other trials in Croatia

Singapore1 site

  • Gleneagles Medical Centre

    Singapore, Central Singapore, 258499

Other trials in Singapore

Switzerland1 site

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

    Bellinzona, Svizzera, 6500

Other trials in Switzerland

About this study

Official title: 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 lymphoma (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.

Read the 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 or Arm B.

Being tested
Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
Keywords
Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell, Lymphoma, Bruton's tyrosine kinase inhibitor, Ibrutinib, Acalabrutinib, Zanubrutinib, Pirtobrutinib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Also called LOXO-305, LY3527727

    Oral Pirtobrutinib

  • IdelalisibDrug

    Also called Zydelig

    Oral

  • BendamustineDrug

    Also called Treanda, Treakisym, Ribomustin, Levact

    IV

  • RituximabDrug

    Also called Rituxan, MabThera, Truxima

    IV

Study groups in NCT04666038
Study groupRoleWhat they receive
Arm A - PirtobrutinibExperimentalParticipants received 200 milligrams (mg) of pirtobrutinib administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
Receives: Drug: Pirtobrutinib
Arm B - Idelalisib plus Rituximab or Bendamustine plus RituximabActive comparatorParticipants received either 150 mg of idelalisib administered twice-daily (BID) orally on Days 1 through 28 of a 28-day cycle in combination with 375 milligram per square meter (mg/m^2) of rituximab by intravenous (IV) infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m^2 every 2 weeks (Q2W) and 3 IV infusions of rituximab 500 mg/m^2 every 4 weeks (Q4W) or 70 mg/m^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
Receives: Drug: Idelalisib; Drug: Bendamustine; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

    PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

    Measured: Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)

Secondary outcomes (7)

  1. PFS Assessed by Investigator

    PFS is defined as time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an investigator according to iwCLL 2018.

    Measured: Randomization to Disease Progression or Death Due to Any Cause (Up to 36 Months)

  2. Overall Survival (OS)

    OS was defined as time from randomization to death due to any cause.

    Measured: Randomization to Death from Any Cause (Up to 36 months)

  3. Time to Next Treatment (TTNT)

    TTNT was defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), therapy of pirtobrutinib for Arm B patients, or death due to any cause, whichever occurs first.

    Measured: Randomization to Subsequent Anticancer Therapy, Therapy of Pirtobrutinib or Death Due to Any Cause (Up to 36 Months)

  4. Event Free Survival (EFS)

    EFS is defined as the time from randomization to the first occurrence of:

    • Documented disease progression per iwCLL 2018 criteria as assessed by Investigator; or
    • Initiation of subsequent anticancer therapy for CLL/SLL; or
    • Unacceptable toxicity leading to treatment discontinuation as assessed by the Investigator; or
    • Death (due to any cause).

    Measured: Randomization to Disease Progression, Subsequent Anticancer Therapy, Unacceptable Toxicity Leading to Treatment Discontinuation, or Death Due to Any Cause (Up to 36 Months)

  5. Percentage of Participants With Overall Response Rate (ORR) Assessed by Investigator

    ORR according to investigator-assessed best overall response (BOR) based on iwCLL 2018 is defined as the number of participants who achieve a BOR of complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) at or before the initiation of subsequent anticancer therapy divided by the total number of participants randomized to each treatment arm.

    Measured: Randomization to Subsequent Anticancer Therapy, Disease Progression or Death Due to Any Cause (Up to 36 Months)

  6. Time to Worsening (TTW) of CLL/SLL Related Symptoms

    TTW was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms.

    The time to sustained patient-reported outcome (PRO) deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A \& Arm B - Idelalisib plus Rituximab) and up to Week 21 + Safety follow-up of up to 5 weeks (Arm B - Bendamustine plus Rituximab) assessment time point prior to disease progression.

    Measured: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)

  7. Time to Worsening (TTW) of Physical Function

    Time of worsening was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms.

    The time to sustained PRO deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A and IdelaR) and up to Week 21 + Safety follow-up (BR) assessment time point prior to disease progression.

    Measured: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start9 Mar 2021
  3. Primary completion29 Aug 2023
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A. Patients who discontinue treatment for toxicity may still be evaluated for cross over at the time of IRC-confirmed PD.
Masking
None (open label)
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666038
Sponsor's protocol ID
18073
Other IDs
J2N-OX-JZNN, LOXO-BTK-20020
Acronym
BRUIN CLL-321
Status last verified
Apr 2026
First submitted
7 Dec 2020
Last updated
24 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Loubert A, Creel K, Bhandari NR, Hess LM, Ruppert AS, Abada P, Regnault A, Payakachat N. Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. J Patient Rep Outcomes. 2026 Jun 22;10(1):109. doi: 10.1186/s41687-026-01126-w.

    PubMed 42329537

  • Sharman JP, Munir T, Grosicki S, Roeker LE, Burke JM, Chen CI, Grzasko N, Follows G, Matrai Z, Sanna A, Qiu L, Feng R, Hua VM, Jurczak W, Ritgen M, Yi S, Bosch F, Coombs CC, Bao K, Patel V, Liu B, Compte L, Guntur A, Wang DY, Hill M, Leow CC, Ghia P, Barr PM. Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321). J Clin Oncol. 2025 Aug;43(22):2538-2549. doi: 10.1200/JCO-25-00166. Epub 2025 Jun 6.

    PubMed 40479620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pirtobrutinib, Idelalisib and Bendamustine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 232 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Italy, China, Japan, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) (time frame: Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04666038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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