Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

This is a study for patients with leukemia-cll/" >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.

View Full Description

Full 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.

View Eligibility Criteria

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:

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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04666038

Recruitment Status:

Active, not recruiting

Sponsor:

Loxo Oncology, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 222 Locations for this study

See Locations Near You

Southern Cancer Center, P.C.
Daphne Alabama, 36526, United States
Mitchell Cancer Institute -University of South Alabama
Mobile Alabama, 36604, United States
Palo Verde Hematology Oncology
Glendale Arizona, 85304, United States
Arizona Oncology Associates, P.C. - HOPE
Tucson Arizona, 85711, United States
Orange Coast Memorial Medical Center
Fountain Valley California, 92708, United States
California Research Institute
Los Angeles California, 90027, United States
Rocky Mountain Cancer Center
Aurora Colorado, 80012, United States
Medical Oncology Hematology Consultants, PA
Newark Delaware, 19713, United States
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Cancer Specialists of North Florida -St Augustine
Jacksonville Florida, 32256, United States
Oncology-Hematology Associates of West Broward
Tamarac Florida, 33321, United States
WellStar Health System
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Illinois Cancer Specialists-Niles
Niles Illinois, 60714, United States
Community Health Network
Indianapolis Indiana, 46250, United States
Arnett Cancer Center
Lafayette Indiana, 47904, United States
University of Kentucky Markey Cancer Center
Lexington Kentucky, 40563, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Mercy Health-Paducah Medical Oncology and Hematology
Paducah Kentucky, 42003, United States
Cancer Center Office of Clinical Research
New Orleans Louisiana, 70112, United States
Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Ascension St. John Hospital
Grosse Pointe Woods Michigan, 48236, United States
Minnesota Oncology/Hematology PA
Saint Paul Minnesota, 55102, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Nebraska Hematology-Oncology
Lincoln Nebraska, 68506, United States
New Jersey Center for Cancer Research
Brick New Jersey, 08724, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
University of Rochester
Rochester New York, 14642, United States
Clinical Research Alliance, Inc.
Westbury New York, 11590, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45236, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Carolina Blood and Cancer Care Associates
Rock Hill South Carolina, 29732, United States
Texas Oncology - Amarillo
Amarillo Texas, 79106, United States
Texas Oncology Cancer Center
Austin Texas, 78705, United States
Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Texas Oncology Fort Worth
Fort Worth Texas, 76104, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Texas Oncology - McAllen
McAllen Texas, 78503, United States
Texas Oncology - San Antonio Medical Center
San Antonio Texas, 78240, United States
Virginia Cancer Specialists, PC
Gainesville Virginia, 20155, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke Virginia, 24014, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States
Canberra Hospital
Garran Australian Capital Territory, 2605, Australia
St Vincent's Hospital
Darlinghurst New South Wales, 2010, Australia
The St. George Hospital
Kogarah New South Wales, 2217, Australia
Ingham Institute of Medical Research
Liverpool New South Wales, NSW21, Australia
Westmead Hospital
Wentworthville New South Wales, 2145, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz Oberösterreich, 4020, Austria
Uniklinikum Salzburg
Salzburg Osterreich, 5020, Austria
Medizinische Universität Wien
Wien , 1090, Austria
CHR Verviers-Onco
Verviers Liege, 4800, Belgium
VITAZ
Sint-Niklaas Oost-Vlaanderen, B-910, Belgium
AZ Delta
Roeselare West Flanders, 8800, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Groupe Jolimont
Haine-Saint-Paul , 7100, Belgium
AZ St-Elisabeth
Herentals , 2200, Belgium
Clinique Saint Pierre Ottignies
Ottignies , 1340, Belgium
Cancer Care Manitoba
Winnipeg Manitoba, R3E 0, Canada
Queen Elizabeth II Health Sciences Center
Halifax Nova Scotia, B3H 1, Canada
Southlake Regional Health Centre
Newmarket Ontario, L3Y 2, Canada
Princess Margaret Hospital (Ontario)
Toronto Ontario, M5G 1, Canada
Peking University First Hospital
Beijing Beijing, 10003, China
Peking University Third Hospital
Beijing Beijing, 10019, China
Xuanwu Hospital Capital Medical University
Xicheng District Beijing, 10005, China
Gansu Province Cancer Hospital
Lanzhou Gansu, 73005, China
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51000, China
Southern Medical University Nanfang Hospital
Guangzhou Guangdong, 51051, China
Hainan Province People's Hospital
Haikou Hainan, 57010, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou Jiangsu, 22100, China
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
The Second Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, , China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi Xinjiang, 83000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Zhejiang Provincial Taizhou Hospital
Linhai Zhejiang, 31700, China
Beijing Hospital
Beijing , 10073, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai , 20002, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Blood Institute of the Chinese Academy of Medical science
Tianjin , 30002, China
University Hospital Split
Split , 21000, Croatia
Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
Zagreb , , Croatia
Fakultni nemocnice Brno
Brno , 62500, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia
CHU De Grenoble Hopital Albert Michallon
Grenoble Cedex 09, 38043, France
Hospital AVICENNE
Bobigny Cedex, 93 00, France
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, 69495, France
CHD Vendee
La Roche-sur-Yon La Roche Sur Yon, 85000, France
Chu Nimes/Institut De Cancerologie Du Gard
Nîmes Nimes, 30900, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen Seine-Maritime, 76038, France
CHRU De Tours
Tours Tours Cedex 9, 37044, France
Centre Hospitalier de la Côte Basque
Bayonne , 64109, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux , 33076, France
CHRU de Brest - Hôpital Morvan
Brest cedex , 29609, France
Centre Hospitalier du Mans
Le Mans , 72000, France
Hopital Saint Vincent De Paul
Lille cedex , 59020, France
Ch Perpignan
Perpignan , 66046, France
Pole Regionalde Cancérologie(CHU de Poitiers)
Politiers , 86021, France
Universitätsklinikum Heidelberg
Heidelberg Baden-Württemberg, 69120, Germany
Universitätsklinikum Ulm
Ulm Baden-Württemberg, 89081, Germany
Uniklinik Köln
Kerpener Köln, 50937, Germany
Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
Langenbeckstraße 1 Mainz, D- 55, Germany
München Klinik Schwabing
Koelner Platz 1 München, 80804, Germany
Universitätsklinikum Schleswig-Holstein
Kiel Schleswig-Holstein, 24105, Germany
Lübecker Onkologische Schwerpunktpraxis
Lübeck Schleswig-Holstein, 23562, Germany
Charité Campus Virchow-Klinikum
Berlin , 12203, Germany
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
University of Pecs 1st. Internalmedicin Clinic Dept
Pecs , 7624, Hungary
Mater Misericordiae Hospital
Dublin 7 , , Ireland
St James's Hosptial
Dublin 8 , D08 N, Ireland
Beaumont Hospital, Dublin
Dublin , DUBLI, Ireland
Rabin Medical Center
Petah Tikva HaMerkaz, , Israel
Soroka Medical Center
Beer Sheva , 84571, Israel
Laniado Medical Center
Netanya , 42449, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Carmel Hospital
Haifa Ḥeifā, 34362, Israel
Irccs Istituto Tumori Giovanni Paolo Ii
Viale Orazio Flacco Bari, 70124, Italy
ASST-Monza -U.O Ematologia Adulti
Monza (MB) -Settore E Piano 2, 20900, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa PI, 56126, Italy
Irccs Crob
Rionero In Vulture Potenza, 85028, Italy
AULSS8 Berica-Ospedale S.Bortolo
Vicenza Veneto, 36100, Italy
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria , 15100, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy
ASST Spedali Civili - Università degli Studi
Brescia , 25123, Italy
A.O.U. Policlinico G.Rodolico - S. Marco
Catania , 95123, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro , 88100, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova , 16132, Italy
Ospedale Papardo
Messina , 98158, Italy
IRCCS Ospedale San Raffaele
Milano , 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
Milano , 20162, Italy
A.O.U. di Modena
Modena , 41124, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
Perugia , 06132, Italy
Ospedale Santa Maria delle Croci
Ravenna , 48020, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma , 00168, Italy
Azienda Ospedaliera Santa Maria Terni
Terni , 05100, Italy
A.O.U. Citta' della Salute e della Scienza di Torino
Torino , 10126, Italy
Az. Osp. "Card G Panico"
Tricase , 4 - 7, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste , 34125, Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona , 37134, Italy
Nagoya Medical Center
Nagoya Aichi, 460-0, Japan
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Ogaki Municipal Hospital
Ogaki-shi Gifu, 503-8, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan
Tokai University Hospital- Isehara Campus
Isehara Kanagawa, 259-1, Japan
Kochi Medical School Hospital
Nankoku Kochi, 783-8, Japan
NHO Sendai Medical Center
Sendai-shi Miyagi-Ken, 983-8, Japan
Tohoku University Hospital
Sendai-shi Miyagi, 980-8, Japan
Kindai University Hospital
Osaka Sayama-shi Osaka, 589 8, Japan
Saitama Medical Center
Kawagoe Saitama, 350-8, Japan
Japanese Foundation for Cancer Research
Koto Tokyo, 135-8, Japan
NTT Medical Center Tokyo
Shinagawa-Ku Tokyo, 141-8, Japan
JCHO Kyushu Hospital
Fukoka-ken , 806 8, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Gachon University Gil Hospital
Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of
Pusan National University Hospital
Busan Pusan-Kwangyǒkshi, 49241, Korea, Republic of
Seoul National University Hospital
Seoul Seoul, Korea, 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu Seoul, 06591, Korea, Republic of
Inje Univ Busan Paik Hospital
Busan , 47392, Korea, Republic of
Wojewodzki Szpital Specjalistyczny
Iwaszkiewicza 5 Legnica, 59-22, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin Lubelskie, 20-08, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk Pomorskie, 80-21, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia Pomorskie, 81-51, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
Brzozów , 36-20, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
Bydgoszcz , 85-16, Poland
Pratia Onkologia Katowice
Katowice , 40519, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
Walbrzych , 58-30, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny Klinika
Wrocław , 50-36, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
Łódź , 93510, Poland
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk Omskaya Oblast', 64401, Russian Federation
Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
Saint Petersburg , 19102, Russian Federation
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg , 19702, Russian Federation
Oncology Dispensary #2 of Krasnodar Region
Sochi , 35405, Russian Federation
Gleneagles Medical Centre
Singapore Central Singapore, 25849, Singapore
Hospital Duran I Reynals
Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Universitario de Toledo
Toledo Castilla La Mancha, 45004, Spain
Complejo Hospitalario Universitario de Santiago de Compostel
Santiago de Compostela La Coruna, 15706, Spain
Hospital Universitario Ramon y Cajal
Madrid Madrid, Comunidad De, 28034, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcón Madrid, 28223, Spain
Hospital General Universitario Gregorio Marañón
Madrid Planta Baja, 28007, Spain
Hospital General de Albacete
Albacete , 02006, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital San Pedro de Alcántara
Caceres , 10003, 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 Virgen del Rocío
Sevilla , 41013, Spain
Hospital Universitario de Alava
Vitoria , 01005, Spain
Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
Bellinzona Svizzera, 6500, Switzerland
China Medical University Hospital
Taichung City Taichung, 40447, Taiwan
Tri-Service General Hospital
Taipei City Taipei, 114, Taiwan
Taipei Veterans General Hospital
Taipei City , 11220, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.) , 33342, Taiwan
Ankara University Medicine Hospital
Mamak Ankara, , Turkey
Istanbul University Istanbul Medicine Faculty
Faith Istanbul, , Turkey
Erciyes University Faculty of Medicine
Kayseri Melikgazi, 38039, Turkey
Gazi University Faculty of Medicine
Ankara Yenimahalle, 06560, Turkey
Ege University Medical Faculty
Izmir , 35100, Turkey
Dokuz Eylul University Faculty of Medicine
Izmir , 35330, Turkey
Aberdeen Royal Infirmary
Aberdeen Aberdeen City, AB25 , United Kingdom
The Royal Cornwall Hospital
Truro Cornwall, TR1 3, United Kingdom
Derriford Hospital
Plymouth Devon, PL6 8, United Kingdom
Castle Hill Hospital
Cottingham East Yorkshire, HU16 , United Kingdom
University College London Hospitals
London Greater London, WC1E , United Kingdom
Norfolk and Norwich Hospital
Norwich Norfolk, NR4 7, United Kingdom
Singleton Hospital
Swansea Sa2 8qa, , United Kingdom
Western General Hospital
Edinburgh Scotland, EH4 2, United Kingdom
Royal Marsden Hospital
Sutton Surrey, SM2 5, United Kingdom
St Johns Hospital at Howden
Livingston West Lothian, EH54 , United Kingdom
St James's University Hospital
Leeds , LS9 7, United Kingdom
Milton Keynes University Hospital
Milton Keynes , MK6 5, United Kingdom
GenesisCare Cambridge
Newmarket , CB8 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT04666038

Recruitment Status:

Active, not recruiting

Sponsor:


Loxo Oncology, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.