Actively Recruiting
A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
Led by Loxo Oncology, Inc. · Updated on 2026-05-19
249
Participants Needed
131
Research Sites
26 weeks
Total Duration
On this page
Sponsors
L
Loxo Oncology, Inc.
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor, as well as those with treatment-nafve CLL/SLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLL/SLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants' ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.
CONDITIONS
Brief Title
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as defined by iwCLL 2018 criteria
- For Part 1: Have received prior treatment for CLL/SLL
- Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- Have received a covalent Bruton tyrosine kinase (BTK) inhibitor
- For Part 2: Have received no prior treatment for CLL/SLL
- For Part 1: Known 17p deletion status (positive or negative)
- For Part 2: Must have 17p deletion (positive)
- Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- Capable of swallowing oral study medication
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2
You will not qualify if you...
- Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- Have a history of Grade 3 or higher bleeding due to treatment with a BTK inhibitor
- Have known or suspected Richter's transformation
- Have known or suspected history of central nervous system involvement by CLL/SLL
- Have had previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization, except for certain skin cancers, cervical carcinoma in situ, localized prostate cancer under surveillance, or localized breast cancer with no active disease for more than 3 years and possibly receiving hormonal therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive oral doses of pirtobrutinib to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Trial Site Locations
Total: 131 locations
1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope National Medical Center
Irvine, California, United States, 92618
Actively Recruiting
4
Palo Alto Medical Foundation Research Institute (PAMFRI)
Palo Alto, California, United States, 94304
Actively Recruiting
5
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
6
Rocky Mountain Cancer Center
Aurora, Colorado, United States, 80012
Actively Recruiting
7
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
8
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Actively Recruiting
9
Mission Cancer + Blood
Waukee, Iowa, United States, 50263
Actively Recruiting
10
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States, 41017
Actively Recruiting
11
American Oncology Partners, PA
Bethesda, Maryland, United States, 20817
Actively Recruiting
12
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
13
Gulfport Memorial Hospital
Gulfport, Mississippi, United States, 39501
Actively Recruiting
14
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Actively Recruiting
15
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
16
Williamette Valley Cancer Institute & Research Center
Eugene, Oregon, United States, 97401
Actively Recruiting
17
Cancer Care Associates Of York
York, Pennsylvania, United States, 17403
Actively Recruiting
18
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States, 38138
Actively Recruiting
19
USO-Texas Oncology-Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
20
Sarah Cannon Research Institute/SCRI
The Woodlands, Texas, United States, 77380
Actively Recruiting
21
USO-Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Actively Recruiting
22
Flinders Medical Centre
Adelaide, Australia, 5042
Actively Recruiting
23
Bankstown-Lidcombe Hospital
Bankstown, Australia, 2200
Actively Recruiting
24
Box Hill Hospital
Box Hill, Australia, 3128
Actively Recruiting
25
Coffs Harbour Health Campus
Coffs Harbour, Australia, 2450
Actively Recruiting
26
Royal Hobart Hospital
Hobart, Australia, 7000
Actively Recruiting
27
ICON Cancer Centre - Kurralta Park
Kurralta Park, Australia, 5037
Actively Recruiting
28
Latrobe Regional Health
Traralgon, Australia, 3844
Actively Recruiting
29
Calvary Mater Newcastle
Waratah, Australia, 2298
Actively Recruiting
30
The Perth Blood Institute - West Perth
West Perth, Australia, 6005
Actively Recruiting
31
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
32
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
33
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium, 8000
Actively Recruiting
34
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
35
Groupe Jolimont
La Louvière, Belgium, 7100
Actively Recruiting
36
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
37
Clinique Saint Pierre
Ottignies, Belgium, 1340
Actively Recruiting
38
AZ Delta vzw
Roeselare, Belgium, 8800
Actively Recruiting
39
AZ Nikolaas
Sint-Niklaas, Belgium, B-9100
Actively Recruiting
40
CHR Verviers - La Tourelle
Verviers, Belgium, 4800
Actively Recruiting
41
Royal Victoria Regional Health Centre
Barrie, Canada, L4M 6M2
Actively Recruiting
42
Saskatoon Cancer Centre
Saskatoon, Canada, S7N4H4
Actively Recruiting
43
Fakultní nemocnice Brno Bohunice
Brno, Czechia, 625 00
Actively Recruiting
44
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
45
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
46
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 12808
Actively Recruiting
47
Aarhus Universitetshospital, Skejby
Aarhus, Denmark, 8200
Actively Recruiting
48
Odense Universitetshospital
Odense, Denmark, 5000
Actively Recruiting
49
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, France, 95107
Actively Recruiting
50
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, France, 14033
Actively Recruiting
51
Centre Hospitalier du Mans
Le Mans, France, 72000
Actively Recruiting
52
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller
Mulhouse, France, 68100
Actively Recruiting
53
Centre Antoine-Lacassagne
Nice, France, 06189
Actively Recruiting
54
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, France, 37044 Cedex 9
Actively Recruiting
55
MV-Zentrum für Onkologie und Hämatologie
Cologne, Germany, 50677
Actively Recruiting
56
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, Germany, 60389
Actively Recruiting
57
OSP Göttingen
Göttingen, Germany, 37073
Actively Recruiting
58
Onkologisches Ambulanzzentrum Hannover
Hanover, Germany, 30171
Actively Recruiting
59
Klinikum Aschaffenburg-Alzenau
Hösbach, Germany, 63768
Actively Recruiting
60
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Germany, 56068
Actively Recruiting
61
Evangelismos General Hospital of Athens
Athens, Greece, 106 76
Actively Recruiting
62
Attikon General University Hospital
Chaïdári, Greece, 12462
Actively Recruiting
63
G. Papanikolaou General Hospital
Thessaloniki, Greece, 570 10
Actively Recruiting
64
General Hospital of Athens "Laiko"
Αthens, Greece, 11526
Actively Recruiting
65
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
66
Dél-Pesti Centrumkórház
Budapest, Hungary, 1097
Actively Recruiting
67
Pécsi Tudományegyetem Klinikai Központ
Pécs, Hungary, 7624
Actively Recruiting
68
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary, 6725
Actively Recruiting
69
A.O.U.C. Policlinico di Bari
Bari, Italy, 70124
Actively Recruiting
70
Azienda Ospedaliero Universitaria S.Anna
Cona, Italy, 44124
Actively Recruiting
71
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
72
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
73
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy, 28100
Actively Recruiting
74
Azienda Ospedale - Università Padova
Padova, Italy, 35128
Actively Recruiting
75
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, Italy, 90146
Actively Recruiting
76
AO Santa Maria della Misericordia
Perugia, Italy, 06132
Actively Recruiting
77
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
78
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
79
IN VIVO
Bydgoszcz, Poland, 85-048
Actively Recruiting
80
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
81
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
82
AIDPORT Sp. z o.o.
Skórzewo, Poland, 60-185
Actively Recruiting
83
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland, 50-367
Actively Recruiting
84
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
85
Spitalul Clinic Colțea
Bucharest, Romania, 030171
Actively Recruiting
86
Institutul Oncologic Cluj
Cluj-Napoca, Romania, 400015
Actively Recruiting
87
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Romania, 200143
Actively Recruiting
88
Institutul Regional de Oncologie
Iași, Romania, 700483
Actively Recruiting
89
Ovidius Clinical Hospital OCH
Ovidiu, Romania, 905900
Actively Recruiting
90
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Slovakia, 975 17
Actively Recruiting
91
Narodny onkologicky ustav
Bratislava, Slovakia, 833 10
Actively Recruiting
92
Univerzitna Nemocnica L. Pasteura Kosice
Košice, Slovakia, 040 11
Actively Recruiting
93
Univerzitna nemocnica Martin
Martin, Slovakia, 036 59
Actively Recruiting
94
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
95
Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea, 58128
Actively Recruiting
96
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
97
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
98
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
99
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea, 07345
Actively Recruiting
100
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
101
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
102
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Spain, 08908
Actively Recruiting
103
Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
104
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Actively Recruiting
105
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
106
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
107
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Actively Recruiting
108
Hospital Costa del Sol
Marbella, Spain, 29603
Actively Recruiting
109
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
110
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
111
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
112
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
113
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
114
Sakarya University School of Medicine
Adapazarı, Turkey (Türkiye), 54100
Actively Recruiting
115
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
116
Ankara University Health Practice and Research Hospitals
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
117
Memorial Antalya Hospital
Antalya, Turkey (Türkiye), 07090
Actively Recruiting
118
Yeditepe Üniversitesi Koşuyolu Hastanesi
Istanbul, Turkey (Türkiye), 34718
Actively Recruiting
119
Ege Universitesi Hastanesi
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
120
Kocaeli Üniversitesi
İzmit, Turkey (Türkiye), 41380
Actively Recruiting
121
VM Medical Park Mersin Hastanesi
Mersin, Turkey (Türkiye), 33200
Actively Recruiting
122
Ondokuz Mayıs Universitesi
Samsun, Turkey (Türkiye), 55139
Actively Recruiting
123
Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
124
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
125
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
126
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
127
Lincoln County Hospital
Lincoln, United Kingdom, LN2 5QY
Actively Recruiting
128
Clatterbridge Cancer Centre - Liverpool
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
129
Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
130
Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
131
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
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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