AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT06588478

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2 study testing Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 129 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
129 sitesin 18 countries
Study dates
3 Jan 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
  • Part 1: Have received prior CLL/SLL treatment
  • Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  • Have received a covalent BTK inhibitor
  • Part 2: Have received no prior treatment for CLL/SLL
  • Part 1 - Known 17p deletion status (positive or negative)
Show all 10Show fewer
  • 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.

Who cannot join

  • Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
  • Have a history of greater than or equal to (>=) Grade 3 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
  • Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
  • nonmelanoma skin cancer or lentigo malignant melanoma
Show all 9Show fewer
  • cervical carcinoma in situ
  • localized prostate cancer undergoing active surveillance, and
  • localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Trial locations and contacts

129 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

129 sites in 18 countries

United States20 sites, 20 recruiting

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

    303-418-7639

    John Burke

    Recruiting

  • USO-Texas Oncology-Central/South Texas

    Austin, Texas, 78705

    512-421-4100

    Jason Melear

    Recruiting

  • American Oncology Partners, PA

    Bethesda, Maryland, 20817

    301-571-2016

    Victor Priego

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Andrew Wilks

    Recruiting

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

    Michael Musci

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    800-826-4673

    Alexey Danilov

    Recruiting

  • Saint Elizabeth Medical Center Edgewood

    Edgewood, Kentucky, 41017

    Miguel Islas-Ohlmayer

    Recruiting

  • Williamette Valley Cancer Institute & Research Center

    Eugene, Oregon, 97401

    541-683-5001

    Jeff Sharman

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    252-744-1015

    Darla Liles

    Recruiting

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39501

    228-575-1234

    Pamela Tuli

    Recruiting

  • USO-Virginia Oncology Associates

    Hampton, Virginia, 23666

    757-368-0437

    Celesteann Bremer

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

    Anthony Nguyen

    Recruiting

  • City of Hope National Medical Center

    Irvine, California, 92618

    626-218-2405

    Alexey Danilov

    Recruiting

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

    Alvaro Alencar

    Recruiting

  • City of Hope National Medical Center, Atlanta Cancer Center

    Newnan, Georgia, 30265

    Sabarish Ayyappan

    Recruiting

  • Palo Alto Medical Foundation Research Institute (PAMFRI)

    Palo Alto, California, 94304

    Roozbeh Mohajer

    Recruiting

  • Stanford Cancer Center

    Palo Alto, California, 94304

    Bita Fakhri

    Recruiting

  • Sarah Cannon Research Institute/SCRI

    The Woodlands, Texas, 77380

    999-999-9999

    SMO Sarah Cannon Research Inst.

    Recruiting

  • Mission Cancer + Blood

    Waukee, Iowa, 50263

    515-282-2921

    Tara Graff

    Recruiting

  • Cancer Care Associates Of York

    York, Pennsylvania, 17403

    717-741-9229

    Jackson Gao

    Recruiting

Other trials in United States

Spain14 sites, 14 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    +34 93 274 61 00 EXT 3806

    Francisco Bosch Albareda

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036

    932275400

    Pablo Mozas

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, 08908

    Ana Oliveira Ramos

    Recruiting

  • Clinica Universidad de Navarra

    Madrid, 28027

    Carlos Grande Garcia

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

    911918932

    Jose Angel Hernandez Rivas

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Adolfo de la Fuente Burguera

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    34913368637

    Javier Lopez Jimenez

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

    91 191 69 71

    JOSE GARCIA VELA

    Recruiting

  • Hospital Costa del Sol

    Marbella, 29603

    +34951976957

    ANGELES MEDINA PEREZ

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    985108000

    Angel Ramirez Payer

    Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

    34923291100

    Almudena Navarro Bailon

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    34942315321

    LUCRECIA YANEZ SAN SEGUNDO

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    3495049697

    Alicia Rodriguez Fernandez

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    34 955013277

    Fatima de la Cruz Vicente

    Recruiting

Other trials in Spain

Australia10 sites, 10 recruiting

  • Flinders Medical Centre

    Adelaide, 5042

    Kate Manos

    Recruiting

  • Bankstown-Lidcombe Hospital

    Bankstown, 2200

    Adrian Yeung

    Recruiting

  • Box Hill Hospital

    Box Hill, 3128

    Ahmad Zargari

    Recruiting

  • Coffs Harbour Health Campus

    Coffs Harbour, 2450

    Kyle Crassini

    Recruiting

  • Royal Hobart Hospital

    Hobart, 7000

    61 3 6166 6655

    Rosemary Harrup

    Recruiting

  • ICON Cancer Centre - Kurralta Park

    Kurralta Park, 5037

    Ka Chun Cheung

    Recruiting

  • Latrobe Regional Health

    Traralgon, 3844

    Michael Ashby

    Recruiting

  • Calvary Mater Newcastle

    Waratah, 2298

    0240143021

    Alex Holmes

    Recruiting

  • The Perth Blood Institute - West Perth

    West Perth, 6005

    Ross Baker

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Sasanka Handunnetti

    Recruiting

Other trials in Australia

Italy10 sites, 10 recruiting

  • A.O.U.C. Policlinico di Bari

    Bari, 70124

    Francesco Albano

    Recruiting

  • Azienda Ospedaliero Universitaria S.Anna

    Cona, 44124

    +390532236977

    Antonio Cuneo

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    00390557947958

    alessandro sanna

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Anna Maria Frustaci

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100

    +39 03213733880

    Riccardo Moia

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova, 35128

    0498217809

    Andrea Visentin

    Recruiting

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

    Palermo, 90146

    +390916802773

    CATERINA PATTI

    Recruiting

  • AO Santa Maria della Misericordia

    Perugia, 06132

    +390755783990

    PAOLO SPORTOLETTI

    Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161

    0649974773

    Maurizio Martelli

    Recruiting

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

    Roma, 00168

    +39 0630157833

    LUCA LAURENTI

    Recruiting

Other trials in Italy

Belgium9 sites, 9 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Virginie De Wilde

    Recruiting

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

    3250452320

    Sylvia Snauwaert

    Recruiting

  • UZ Gent

    Ghent, 9000

    +32 9 332 21 25

    Fritz Offner

    Recruiting

  • Groupe Jolimont

    La Louvière, 7100

    VANESSA DELRIEU

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Ann Janssens

    Recruiting

  • Clinique Saint Pierre

    Ottignies, 1340

    Thierry Connerotte

    Recruiting

  • AZ Delta vzw

    Roeselare, 8800

    003251237322

    Lien Deleu

    Recruiting

  • AZ Nikolaas

    Sint-Niklaas, B-9100

    Vanessa Van Hende

    Recruiting

  • CHR Verviers - La Tourelle

    Verviers, 4800

    087219418

    Gaetan Vanstraelen

    Recruiting

Other trials in Belgium

Turkey (Türkiye)9 sites, 9 recruiting

  • Sakarya University School of Medicine

    Adapazarı, 54100

    Tuba Hacibekiroglu

    Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    Ankara, 06200

    Mehmet Dal

    Recruiting

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06620

    00905326560206

    Selami Toprak

    Recruiting

  • Memorial Antalya Hospital

    Antalya, 07090

    Fatih Demirkan

    Recruiting

  • Yeditepe Üniversitesi Koşuyolu Hastanesi

    Istanbul, 34718

    Elif Birtas Atesoglu

    Recruiting

  • Ege Universitesi Hastanesi

    Izmir, 35100

    905325566128

    Güray Saydam

    Recruiting

  • Kocaeli Üniversitesi

    İzmit, 41380

    05076771924

    Ozgur Mehtap

    Recruiting

  • VM Medical Park Mersin Hastanesi

    Mersin, 33200

    111111111

    ANIL TOMBAK

    Recruiting

  • Ondokuz Mayıs Universitesi

    Samsun, 55139

    Mehmet Turgut

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom8 sites, 8 recruiting

  • Heartlands Hospital

    Birmingham, B9 5SS

    Shankara Paneesha

    Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    0141 301 7711

    Mark Rafferty

    Recruiting

  • Northwick Park Hospital

    Harrow, HA1 3UJ

    02088692742

    Thomas Lofaro

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF

    01132433144

    Talha Munir

    Recruiting

  • Lincoln County Hospital

    Lincoln, LN2 5QY

    07833432491

    Marios Tsoutsoukis

    Recruiting

  • Clatterbridge Cancer Centre - Liverpool

    Liverpool, L7 8YA

    Stella Williams

    Recruiting

  • Hammersmith Hospital

    London, W12 0HS

    Sasha Marks

    Recruiting

  • Singleton Hospital

    Swansea, SA2 8QA

    017920285547

    Unmesh Mohite

    Recruiting

Other trials in United Kingdom

France6 sites, 6 recruiting

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    Argenteuil, 95107

    driss chaoui

    Recruiting

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen, 14033

    Baptiste DELAPIERRE

    Recruiting

  • Centre Hospitalier du Mans

    Le Mans, 72000

    +33255463467

    Kamel Laribi

    Recruiting

  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller

    Mulhouse, 68100

    Bernard Drenou

    Recruiting

  • Centre Antoine-Lacassagne

    Nice, 06189

    Luca INCHIAPPA

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    Tours, 37044 Cedex 9

    Caroline Dartigeas

    Recruiting

Other trials in France

Germany6 sites, 6 recruiting

  • MV-Zentrum für Onkologie und Hämatologie

    Cologne, 50677

    Jan-Phillip Weber

    Recruiting

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, 60389

    00496956005621

    Christian Schmitt

    Recruiting

  • OSP Göttingen

    Göttingen, 37073

    0049551488795915

    Michael Metz

    Recruiting

  • Onkologisches Ambulanzzentrum Hannover

    Hanover, 30171

    004989979680

    Michael Gärtner

    Recruiting

  • Klinikum Aschaffenburg-Alzenau

    Hösbach, 63768

    0049 60214527391

    Manfred Welslau

    Recruiting

  • InVO Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

    49 261 921 5693-0

    Rudolf Weide

    Recruiting

Other trials in Germany

Romania6 sites, 6 recruiting

  • Fundeni Clinical Institute

    Bucharest, 022328

    40212750500

    Ana Maria Moldovianu

    Recruiting

  • Spitalul Clinic Colțea

    Bucharest, 030171

    0744150652

    Gabriela Borsaru

    Recruiting

  • Institutul Oncologic Cluj

    Cluj-Napoca, 400015

    400741337480

    Ciprian Tomuleasa

    Recruiting

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

    0735439439

    Ocroteala Luminita

    Recruiting

  • Institutul Regional de Oncologie

    Iași, 700483

    40722565781

    Catalin Danaila

    Recruiting

  • Ovidius Clinical Hospital OCH

    Ovidiu, 905900

    0724877013

    Andreea Caloian

    Recruiting

Other trials in Romania

South Korea6 sites, 6 recruiting

  • Pusan National University Hospital

    Busan, 49241

    +821089371258

    Ho-Jin Shin

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 58128

    DEOK HWAN YANG

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Ja Min Byun

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Seok Jin Kim

    Recruiting

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

    Seoul, 06591

    82222586056

    Ki-Seong Eom

    Recruiting

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, 07345

    +821042324067

    Youngwoo Jeon

    Recruiting

Other trials in South Korea

Poland5 sites, 5 recruiting

  • IN VIVO

    Bydgoszcz, 85-048

    Jaroslaw Czyz

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    +4832 3499751

    Sebastian Grosicki

    Recruiting

  • Pratia MCM Krakow

    Krakow, 30-727

    +48 602338290

    Wojciech Jurczak

    Recruiting

  • AIDPORT Sp. z o.o.

    Skórzewo, 60-185

    Michal Kwiatek

    Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-367

    501419272

    Tomasz Wrobel

    Recruiting

Other trials in Poland

Czechia4 sites

  • Fakultní nemocnice Brno Bohunice

    Brno, 625 00

    Active, not recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Active, not recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

    Completed

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

    Active, not recruiting

Other trials in Czechia

Greece4 sites, 4 recruiting

  • Evangelismos General Hospital of Athens

    Athens, 106 76

    +302107201721

    Maria Bouzani

    Recruiting

  • Attikon General University Hospital

    Chaïdári, 12462

    0030 2105832307

    Vasiliki Pappa

    Recruiting

  • G. Papanikolaou General Hospital

    Thessaloniki, 570 10

    +302313307533

    Niki Stavroyianni

    Recruiting

  • General Hospital of Athens "Laiko"

    Αthens, 11526

    Theodoros Vassilakopoulos

    Recruiting

Other trials in Greece

Hungary4 sites, 4 recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    36208258660

    ZSOLT GYORGY Nagy

    Recruiting

  • Dél-Pesti Centrumkórház

    Budapest, 1097

    +3630 455 8218

    Zoltan Matrai

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, 7624

    +36 72 536 000

    Hussain Alizadeh

    Recruiting

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

    +36704391136

    Szabolcs Modok

    Recruiting

Other trials in Hungary

Slovakia4 sites, 4 recruiting

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

    +421915803313

    Anna Vallova

    Recruiting

  • Narodny onkologicky ustav

    Bratislava, 833 10

    Eva Mikuskova

    Recruiting

  • Univerzitna Nemocnica L. Pasteura Kosice

    Košice, 040 11

    +421556404410

    Tomas Guman

    Recruiting

  • Univerzitna nemocnica Martin

    Martin, 036 59

    421902101385

    Juraj Sokol

    Recruiting

Other trials in Slovakia

Canada2 sites, 2 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, L4M 6M2

    Derek Nay

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, S7N4H4

    Julie Stakiw

    Recruiting

Other trials in Canada

Denmark2 sites, 2 recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200

    Hans Bentzen

    Recruiting

  • Odense Universitetshospital

    Odense, 5000

    Annika Rewes

    Recruiting

Other trials in Denmark

About this study

Official title: 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/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Being tested
Pirtobrutinib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • PirtobrutinibDrug

    Administered Orally.

Study groups in NCT06588478
Study groupRoleWhat they receive
Pirtobrutinib Standard Dose (Dose 1)-Part 1Active comparatorPirtobrutinib administered orally.
Receives: Drug: Pirtobrutinib
Pirtobrutinib Dose 2-Part 1ExperimentalPirtobrutinib administered orally.
Receives: Drug: Pirtobrutinib
Pirtobrutinib Dose 3-Part 1ExperimentalPirtobrutinib administered orally.
Receives: Drug: Pirtobrutinib
Pirtobrutinib Standard Dose-Part 2ExperimentalPirtobrutinib administered orally.
Receives: Drug: Pirtobrutinib

What is being measured

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

  1. Overall Response Rate

    Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.

    Measured: Baseline up to 3 years

Secondary outcomes (1)

  1. Duration of Response

    Duration of response is defined as the time from the date of the first documented CR, CRi, nPR, or PR to disease progression (per iwCLL 2018) or death from any cause.

    Measured: Baseline up to 3 years

Timeline

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

  1. First posted19 Sep 2024
  2. Study start3 Jan 2025
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
249 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588478
Sponsor's protocol ID
18877
Other IDs
2024-515689-15-01, J2N-MC-JZNX
Status last verified
Nov 2026
First submitted
6 Sep 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 129 sites in 18 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Spain, Australia, Italy, Belgium and 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Baseline up to 3 years). 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 NCT06588478.

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 4 Nov 2026.

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