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)

NCT ID: NCT04666038

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2027-05-31

Brief 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. Participation could last up to four years, and possibly longer, if the disease does not progress.

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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A - Pirtobrutinib

Participants 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.

Group Type: EXPERIMENTAL

Pirtobrutinib

Intervention Type: DRUG

Oral Pirtobrutinib

Arm B - Idelalisib plus Rituximab or Bendamustine plus Rituximab

Participants 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.

Group Type: ACTIVE_COMPARATOR

Idelalisib

Intervention Type: DRUG

Oral

Bendamustine

Intervention Type: DRUG

IV

Rituximab

Intervention Type: DRUG

IV

Interventions

Pirtobrutinib

Oral Pirtobrutinib

Intervention Type: DRUG

Idelalisib

Oral

Intervention Type: DRUG

Bendamustine

IV

Intervention Type: DRUG

Rituximab

IV

Intervention Type: DRUG

Other Intervention Names

LOXO-305; LY3527727; Zydelig; Treanda, Treakisym, Ribomustin, Levact; Rituxan, MabThera, Truxima

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marisa Hill, MD

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

Southern Cancer Center, P.C.

Daphne, Alabama, United States

Mitchell Cancer Institute -University of South Alabama

Mobile, Alabama, United States

Palo Verde Hematology Oncology

Glendale, Arizona, United States

Arizona Oncology Associates, P.C. - HOPE

Tucson, Arizona, United States

Orange Coast Memorial Medical Center

Fountain Valley, California, United States

California Research Institute

Los Angeles, California, United States

Rocky Mountain Cancer Center

Aurora, Colorado, United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Cancer Specialists of North Florida -St Augustine

Jacksonville, Florida, United States

Oncology-Hematology Associates of West Broward

Tamarac, Florida, United States

WellStar Health System

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

Arnett Cancer Center

Lafayette, Indiana, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Mercy Health-Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States

Cancer Center Office of Clinical Research

New Orleans, Louisiana, United States

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Ascension St. John Hospital

Grosse Pointe Woods, Michigan, United States

Minnesota Oncology/Hematology PA

Saint Paul, Minnesota, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Nebraska Hematology-Oncology

Lincoln, Nebraska, United States

New Jersey Center for Cancer Research

Brick, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Clinical Research Alliance, Inc.

Westbury, New York, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

Texas Oncology - Amarillo

Amarillo, Texas, United States

Texas Oncology Cancer Center

Austin, Texas, United States

Texas Oncology - Medical City Dallas

Dallas, Texas, United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Texas Oncology Fort Worth

Fort Worth, Texas, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Texas Oncology - McAllen

McAllen, Texas, United States

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States

Virginia Cancer Specialists, PC

Gainesville, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia Inc

Roanoke, Virginia, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

The St. George Hospital

Kogarah, New South Wales, Australia

Ingham Institute of Medical Research

Liverpool, New South Wales, Australia

Westmead Hospital

Wentworthville, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Uniklinikum Salzburg

Salzburg, Osterreich, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Medizinische Universität Wien

Vienna, , Austria

CHR Verviers-Onco

Verviers, Liege, Belgium

VITAZ

Sint-Niklaas, Oost-Vlaanderen, Belgium

AZ Delta

Roeselare, West Flanders, Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Groupe Jolimont

Haine-Saint-Paul, , Belgium

AZ St-Elisabeth

Herentals, , Belgium

Clinique Saint Pierre Ottignies

Ottignies, , Belgium

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Princess Margaret Hospital (Ontario)

Toronto, Ontario, Canada

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital Capital Medical University

Xicheng District, Beijing Municipality, China

Gansu Province Cancer Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Hainan Province People's Hospital

Haikou, Hainan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial Taizhou Hospital

Linhai, Zhejiang, China

Beijing Hospital

Beijing, , China

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Blood Institute of the Chinese Academy of Medical science

Tianjin, , China

University Hospital Split

Split, , Croatia

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

Zagreb, , Croatia

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

CHU De Grenoble Hopital Albert Michallon

Grenoble, Cedex 09, France

Hospital AVICENNE

Bobigny, Cedex, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, Cedex, France

CHD Vendee

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

Chu Nimes/Institut De Cancerologie Du Gard

Nîmes, Nimes, France

Pole Regionalde Cancérologie(CHU de Poitiers)

Politiers, Politiers, France

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

Rouen, Seine-Maritime, France

CHRU De Tours

Tours, Tours Cedex 9, France

Centre Hospitalier de la Côte Basque

Bayonne, , France

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

Bordeaux, , France

CHRU de Brest - Hôpital Morvan

Brest, , France

Centre Hospitalier du Mans

Le Mans, , France

Hopital Saint Vincent De Paul

Lille, , France

Ch Perpignan

Perpignan, , France

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Uniklinik Köln

Kerpener, Köln, Germany

Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik

Langenbeckstraße 1, Mainz, Germany

München Klinik Schwabing

Koelner Platz 1, München, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Lübecker Onkologische Schwerpunktpraxis

Lübeck, Schleswig-Holstein, Germany

Charité Campus Virchow-Klinikum

Berlin, , Germany

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

University of Pecs 1st. Internalmedicin Clinic Dept

Pécs, , Hungary

St James's Hosptial

Dublin, , Ireland

Beaumont Hospital, Dublin

Dublin, , Ireland

Mater Misericordiae Hospital

Dublin, , Ireland

Rabin Medical Center

Petah Tikva, Central District, Israel

Soroka Medical Center

Beersheba, , Israel

Laniado Medical Center

Netanya, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Carmel Hospital

Haifa, Ḥeifā, Israel

Irccs Istituto Tumori Giovanni Paolo Ii

Viale Orazio Flacco, Bari, Italy

ASST-Monza -U.O Ematologia Adulti

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

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, Italy

Irccs Crob

Rionero in Vulture, Potenza, Italy

AULSS8 Berica-Ospedale S.Bortolo

Vicenza, Veneto, Italy

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, , Italy

ASST Spedali Civili - Università degli Studi

Brescia, , Italy

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

Catania, , Italy

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Ospedale Papardo

Messina, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

Milan, , Italy

A.O.U. di Modena

Modena, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

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

Perugia, , Italy

Ospedale Santa Maria delle Croci

Ravenna, , Italy

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

Roma, , Italy

Azienda Ospedaliera Santa Maria Terni

Terni, , Italy

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

Torino, , Italy

Az. Osp. "Card G Panico"

Tricase, , Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, , Italy

Ospedale Policlinico Giambattista Rossi, Borgo Roma

Verona, , Italy

Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Ogaki Municipal Hospital

Ogaki-shi, Gifu, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Tokai University Hospital- Isehara Campus

Isehara, Kanagawa, Japan

Kochi Medical School Hospital

Nankoku, Kochi, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

NHO Sendai Medical Center

Sendai, Miyagi, Japan

Kindai University Hospital

Osaka Sayama-shi, Osaka, Japan

Saitama Medical Center

Kawagoe, Saitama, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-Ku, Tokyo, Japan

JCHO Kyushu Hospital

Fukoka-ken, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Okayama University Hospital

Okayama, , Japan

Osaka University Hospital

Osaka, , Japan

Wojewodzki Szpital Specjalistyczny

Iwaszkiewicza 5, Legnica, Poland

Centrum Onkologii Ziemi Lubelskiej

Lublin, Lublin Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Szpitale Pomorskie Sp. z o. o.

Gdynia, Pomeranian Voivodeship, Poland

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

Brzozów, , Poland

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

Bydgoszcz, , Poland

Pratia Onkologia Katowice

Katowice, , Poland

Pratia MCM Krakow

Krakow, , Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

Lodz, , Poland

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

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

Warsaw, , Poland

Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu

Wałbrzych, , Poland

Uniwersytecki Szpital Kliniczny Klinika

Wroclaw, , Poland

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

Omsk, Omsk Oblast, Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Oncology Dispensary #2 of Krasnodar Region

Sochi, , Russia

Gleneagles Medical Centre

Singapore, Central Singapore, Singapore

Gachon University Gil Hospital

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

Pusan National University Hospital

Busan, Pusan-Kwangyǒkshi, South Korea

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

Seocho-Gu, Seoul, South Korea

Seoul National University Hospital

Seoul, Seoul, Korea, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Inje Univ Busan Paik Hospital

Busan, , South Korea

Hospital Duran I Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Toledo

Toledo, Castille-La Mancha, Spain

Complejo Hospitalario Universitario de Santiago de Compostel

Santiago de Compostela, La Coruna, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Planta Baja, Spain

Hospital General de Albacete

Albacete, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario Infanta Leonor-INTERNAL MED

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Marques De Valdecilla

Santander, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Universitario de Alava

Vitoria-Gasteiz, , Spain

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

Bellinzona, Svizzera, Switzerland

China Medical University Hospital

Taichung, Taichung, Taiwan

Tri-Service General Hospital

Taipei City, Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

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

Taipei Veterans General Hospital

Taipei, , Taiwan

Ankara University Medicine Hospital

Mamak, Ankara, Turkey (Türkiye)

Istanbul University Istanbul Medicine Faculty

Faith, Istanbul, Turkey (Türkiye)

Erciyes University Faculty of Medicine

Kayseri, Melikgazi, Turkey (Türkiye)

Gazi University Faculty of Medicine

Ankara, Yenimahalle, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Dokuz Eylul University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, Aberdeen City, United Kingdom

The Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Derriford Hospital

Plymouth, Devon, United Kingdom

Castle Hill Hospital

Cottingham, East Yorkshire, United Kingdom

University College London Hospitals

London, Greater London, United Kingdom

Norfolk and Norwich Hospital

Norwich, Norfolk, United Kingdom

Singleton Hospital

Swansea, SA2 8QA, United Kingdom

Western General Hospital

Edinburgh, Scotland, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

St Johns Hospital at Howden

Livingston, West Lothian, United Kingdom

St James's University Hospital

Leeds, , United Kingdom

Milton Keynes University Hospital

Milton Keynes, , United Kingdom

GenesisCare Cambridge

Newmarket, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; China; Croatia; Czechia; France; Germany; Hungary; Ireland; Israel; Italy; Japan; Poland; Russia; Singapore; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40479620 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2N-OX-JZNN

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-BTK-20020

Identifier Type: OTHER

Identifier Source: secondary_id

18073

Identifier Type: -

Identifier Source: org_study_id