Actively Recruiting
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Led by Loxo Oncology, Inc. · Updated on 2026-04-20
662
Participants Needed
144
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
CONDITIONS
Official Title
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring therapy
- Known 17p deletion status for Part 1; must have 17p deletion for Part 2
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Adequate organ function including platelets 50 x 10�/L or 30 x 10�/L with marrow involvement
- Hemoglobin 8 g/dL or 6 g/dL with marrow involvement
- Absolute neutrophil count 0.75 x 10�/L or 0.50 x 10�/L with marrow involvement
- Estimated creatinine clearance 30 mL/min
You will not qualify if you...
- Known or suspected Richter's transformation or other aggressive lymphoma
- Known or suspected central nervous system involvement
- Significant history of renal, neurologic, psychiatric, endocrine, metabolic, or immune disease
- Active uncontrolled autoimmune blood disorders
- Significant cardiovascular disease including ejection fraction below 40% or ongoing atrial fibrillation/flutter
- Active hepatitis B or C infection
- Active cytomegalovirus infection
- Active uncontrolled systemic bacterial, viral, or fungal infection
- Known HIV infection
- Significant malabsorption syndrome or conditions affecting oral drug absorption
- Ongoing inflammatory bowel disease
- Previous treatment for CLL/SLL (for Part 2 participants must be treatment-nave)
- Concurrent investigational or anticancer therapy except hormonal therapy
- Need for therapeutic anticoagulation with warfarin or vitamin K antagonists
- Use of more than 20 mg prednisone daily or equivalent steroid dose at first study drug dose
- Vaccination with live vaccine within 28 days before randomization
- Chronic therapy with strong CYP3A inhibitors that cannot be stopped before study drug
- Known allergy or anaphylaxis to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 144 locations
1
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
Actively Recruiting
2
TOI Clinical Research
Cerritos, California, United States, 90703
Actively Recruiting
3
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California, United States, 94305
Actively Recruiting
4
California Cancer Associates for Research and Excellence
San Marcos, California, United States, 92069
Active, Not Recruiting
5
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916-2233
Actively Recruiting
6
Cancer Specialists of North Florida -St Augustine
Saint Augustine, Florida, United States, 32086
Actively Recruiting
7
Florida Cancer Specialists East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
8
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States, 70809
Active, Not Recruiting
9
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States, 70112
Active, Not Recruiting
10
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
Actively Recruiting
11
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Actively Recruiting
12
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Active, Not Recruiting
13
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
Active, Not Recruiting
14
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Kelsey Research Foundation
Houston, Texas, United States, 77025
Active, Not Recruiting
16
Lumi Research
Kingwood, Texas, United States, 77339
Actively Recruiting
17
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Actively Recruiting
18
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
Actively Recruiting
19
MultiCare Health System Institute for Research and Innovation
Spokane, Washington, United States, 99218
Active, Not Recruiting
20
Alexander Fleming
Ciudad Autónoma de Buenos Aire, Argentina, C1426ANZ
Actively Recruiting
21
Hospital Privado De Comunidad
Mar del Plata, Argentina, 7600
Active, Not Recruiting
22
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, Argentina, 3000
Actively Recruiting
23
One Clinical Research
Nedlands, Australia, 6009
Active, Not Recruiting
24
Western Health, Sunshine Hospital
St Albans, Australia, 3021
Active, Not Recruiting
25
The Perth Blood Institute
West Perth, Australia, 6005
Actively Recruiting
26
Hanusch Krankenhaus
Vienna, Austria, 1140
Active, Not Recruiting
27
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
28
VITAZ
Sint-Niklaas, Belgium, B-9100
Actively Recruiting
29
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, Brazil, 14784400
Actively Recruiting
30
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
Botucatu, Brazil, 18618-687
Actively Recruiting
31
Hemocentro Unicamp
Campinas, Brazil, 13083-878
Actively Recruiting
32
Hospital Uopeccan - Centro de Pesquisa Clinica
Cascavel, Brazil, 85806-300
Active, Not Recruiting
33
Centro Integrado de Oncologia de Curitiba
Curitiba, Brazil, 80810050
Active, Not Recruiting
34
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Brazil, 81520060
Actively Recruiting
35
Instituto do Câncer - Hospital São Vicente de Paulo
Passo Fundo, Brazil, 99010090
Actively Recruiting
36
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, Brazil, 90110270
Actively Recruiting
37
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, Brazil, 14051-140
Actively Recruiting
38
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, Brazil, 09060-650
Actively Recruiting
39
Centro Integrado de Pesquisa Clinica
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
40
Hospital BP
São Paulo, Brazil, 01321-001
Actively Recruiting
41
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil, 05403-000
Actively Recruiting
42
Hospital Santa Marcelina
São Paulo, Brazil, 08270-120
Actively Recruiting
43
Royal Victoria Hospital-Montreal
Montreal, Canada, H3A 1A1
Terminated
44
Hopital de L'Enfant Jesus
Québec, Canada, G1J 1Z4
Actively Recruiting
45
Cancer Care Manitoba
Winnipeg, Canada, R3E 0V9
Active, Not Recruiting
46
Inmunocel
Santiago, Chile, 7580206
Active, Not Recruiting
47
CeCim Biocinetic
Santiago, Chile, 8320000
Active, Not Recruiting
48
Sociedad de Investigaciones Médicas Limitada
Temuco, Chile, 4780000
Actively Recruiting
49
Centro de Investigaciones Clínicas Viña del Mar (CIC)
Viña del Mar, Chile, 2520000
Active, Not Recruiting
50
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Active, Not Recruiting
51
Hunan Cancer Hospital
Changsha, China, 410013
Active, Not Recruiting
52
Sun Yat-sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
53
Southern Medical University Nanfang Hospital
Guangzhou, China, 510515
Active, Not Recruiting
54
Hainan General Hospital
Haikou, China, 570311
Active, Not Recruiting
55
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, China, 310003
Actively Recruiting
56
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310009
Active, Not Recruiting
57
Anhui Provincial Hospital
Hefei, China, 230001
Actively Recruiting
58
The Second Hospital of Anhui Medical University
Hefei, China, 231200
Actively Recruiting
59
Jiangxi Provincial Cancer Hospital
Nanchang, China, 330029
Active, Not Recruiting
60
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China, 530021
Active, Not Recruiting
61
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
62
Blood Institute of the Chinese Academy of Medical science
Tianjin, China, 300020
Active, Not Recruiting
63
Tianjin Medical University General Hospital
Tianjin, China, 300052
Active, Not Recruiting
64
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China, 830000
Active, Not Recruiting
65
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430022
Active, Not Recruiting
66
Wu Han Tongji Hospital
Wuhan, China, 430030
Active, Not Recruiting
67
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, China, 322000
Active, Not Recruiting
68
Fakultni nemocnice Brno
Brno, Czechia, 62500
Actively Recruiting
69
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
70
Fakultni Nemocnice Ostrava
Ostrava, Czechia, 708 52
Actively Recruiting
71
Fakultni Nemocnice Plzen
Pilsen, Czechia, 305 99
Actively Recruiting
72
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
73
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
Active, Not Recruiting
74
CHD Vendee
La Roche-sur-Yon, France, 85000
Actively Recruiting
75
Centre Hospitalier du Mans
Le Mans, France, 72000
Actively Recruiting
76
Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
Limoges, France, 87042
Actively Recruiting
77
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Actively Recruiting
78
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
79
Hopital de la Pitie Salpetriere
Paris, France, 75651
Actively Recruiting
80
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
81
Hôpital de Pontchaillou
Rennes, France, 35033
Actively Recruiting
82
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, France, 76038
Actively Recruiting
83
CHRU De Tours
Tours, France, 37044
Actively Recruiting
84
Gemeinschaftspraxis für Hämatologie und Onkologie (Gefos)
Dortmund, Germany, 44309
Active, Not Recruiting
85
Onkologische Gemeinschaftspraxis / BAG
Dresden, Germany, 01307
Actively Recruiting
86
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik 1
Dresden, Germany, 01307
Active, Not Recruiting
87
Universitätsklinikum Ulm
Ulm, Germany, 89075
Active, Not Recruiting
88
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, Hungary, 4004
Actively Recruiting
89
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary, 9700
Active, Not Recruiting
90
Hadassah Medical Center
Jerusalem, Israel, 9112001
Active, Not Recruiting
91
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Active, Not Recruiting
92
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15100
Actively Recruiting
93
Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Active, Not Recruiting
94
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy, 47014
Actively Recruiting
95
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
96
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
97
Azienda Unita Sanitaria Locale di Reggio Emilia
Reggio Emilia, Italy, 42122
Active, Not Recruiting
98
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Active, Not Recruiting
99
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
100
Dunedin Hospital
Dunedin, New Zealand, 9016
Active, Not Recruiting
101
Waikato Hospital
Hamilton, New Zealand, 3204
Active, Not Recruiting
102
Momentum Clinical Research
Newtown, New Zealand, 6242
Actively Recruiting
103
Middlemore Clinical Trials
Papatoetoe, New Zealand, 2025
Actively Recruiting
104
KO-MED Centra Kliniczne
Biała Podlaska, Poland, 21500
Active, Not Recruiting
105
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
Bydgoszcz, Poland, 85-168
Actively Recruiting
106
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Active, Not Recruiting
107
Pratia Onkologia Katowice
Katowice, Poland, 40519
Actively Recruiting
108
Pratia MCM Krakow
Krakow, Poland, 30-510
Actively Recruiting
109
Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland, 20-081
Active, Not Recruiting
110
AIDPORT Sp. z o.o.
Skórzewo, Poland, 60-185
Actively Recruiting
111
Uniwersytecki Szpital Kliniczny Klinika
Wroclaw, Poland, 50-367
Actively Recruiting
112
Inje Univ Busan Paik Hospital
Busan, South Korea, 47392
Actively Recruiting
113
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, South Korea, 06591
Active, Not Recruiting
114
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
115
Samsung Medical Center
Seoul, South Korea, 06351
Active, Not Recruiting
116
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
117
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Active, Not Recruiting
118
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 8035
Active, Not Recruiting
119
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Active, Not Recruiting
120
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, Spain, 28031
Active, Not Recruiting
121
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
122
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Active, Not Recruiting
123
Hospital Costa Del Sol
Marbella, Spain, 29600
Active, Not Recruiting
124
Clinica Universitaria De Navarra
Pamplona, Spain, 31008
Actively Recruiting
125
Hospital De Navarra
Pamplona, Spain, 31008
Active, Not Recruiting
126
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
127
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
128
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Active, Not Recruiting
129
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan, 710
Actively Recruiting
130
Chang Gung Memorial Hospital - Chiayi
Chiayi County, Taiwan, 61363
Active, Not Recruiting
131
National Cheng-Kung Uni. Hosp.
Tainan, Taiwan, 704
Active, Not Recruiting
132
Koo Foundation Sun Yan-Sen Cancer Center
Taipei, Taiwan, 112
Actively Recruiting
133
Gazi University Faculty of Medicine
Ankara, Turkey (Türkiye), 6500
Active, Not Recruiting
134
9 Eylul University Hospital
Balçova, Turkey (Türkiye), 35100
Active, Not Recruiting
135
Ege Üniversitesi
Bornova, Turkey (Türkiye), 35040
Active, Not Recruiting
136
Istanbul University Istanbul Medicine Faculty
Faith, Turkey (Türkiye), 34732
Active, Not Recruiting
137
American Hospital
Istanbul, Turkey (Türkiye), 34365
Active, Not Recruiting
138
Acıbadem Maslak Hastanesi
Istanbul, Turkey (Türkiye), 34457
Completed
139
Ankara University Medicine Hospital
Mamak, Turkey (Türkiye), 06590
Actively Recruiting
140
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
141
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
142
HOPE Centre
Leicester, United Kingdom, LE1 5WW
Active, Not Recruiting
143
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Active, Not Recruiting
144
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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