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New hope for Tough-to-Treat blood cancers: pirtobrutinib trial launches

NCT ID NCT06588478

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests three different doses of a drug called pirtobrutinib in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer came back or didn't respond after treatment with a BTK inhibitor. About 249 participants will take part. The goal is to see which dose works best and is safest. The study also includes a separate group of people who have never been treated for CLL/SLL and have a specific genetic change (17p deletion).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 249 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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. Exclusion Criteria: * 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 * 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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    131 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U.C. Policlinico di Bari

    RECRUITING

    Bari, 70124, Italy

  • AIDPORT Sp. z o.o.

    RECRUITING

    Skórzewo, 60-185, Poland

  • AO Santa Maria della Misericordia

    RECRUITING

    Perugia, 06132, Italy

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • AZ Delta vzw

    RECRUITING

    Roeselare, 8800, Belgium

  • AZ Nikolaas

    RECRUITING

    Sint-Niklaas, B-9100, Belgium

  • AZ Sint-Jan Brugge-Oostende AV

    RECRUITING

    Bruges, 8000, Belgium

  • Aarhus Universitetshospital, Skejby

    RECRUITING

    Aarhus, 8200, Denmark

  • American Oncology Partners, PA

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Ankara University Health Practice and Research Hospitals

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Attikon General University Hospital

    RECRUITING

    Chaïdári, 12462, Greece

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

    RECRUITING

    Palermo, 90146, Italy

  • Azienda Ospedale - Università Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    RECRUITING

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria S.Anna

    RECRUITING

    Cona, 44124, Italy

  • Bankstown-Lidcombe Hospital

    RECRUITING

    Bankstown, 2200, Australia

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Box Hill Hospital

    RECRUITING

    Box Hill, 3128, Australia

  • CHR Verviers - La Tourelle

    RECRUITING

    Verviers, 4800, Belgium

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, 2298, Australia

  • Cancer Care Associates Of York

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Centre Antoine-Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    RECRUITING

    Tours, 37044 Cedex 9, France

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    RECRUITING

    Caen, 14033, France

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    RECRUITING

    Argenteuil, 95107, France

  • Centre Hospitalier du Mans

    RECRUITING

    Le Mans, 72000, France

  • Centrum für Hämatologie und Onkologie Bethanien

    RECRUITING

    Frankfurt, 60389, Germany

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun-gun, 58128, South Korea

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope National Medical Center

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center, Atlanta Cancer Center

    RECRUITING

    Newnan, Georgia, 30265, United States

  • Clatterbridge Cancer Centre - Liverpool

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • Clinica Universidad de Navarra

    RECRUITING

    Madrid, 28027, Spain

  • Clinique Saint Pierre

    RECRUITING

    Ottignies, 1340, Belgium

  • Coffs Harbour Health Campus

    RECRUITING

    Coffs Harbour, 2450, Australia

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Henderson, Nevada, 89074, United States

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    RECRUITING

    Ankara, 06200, Turkey (Türkiye)

  • Dél-Pesti Centrumkórház

    RECRUITING

    Budapest, 1097, Hungary

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Ege Universitesi Hastanesi

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Evangelismos General Hospital of Athens

    RECRUITING

    Athens, 106 76, Greece

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

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 100 34, Czechia

  • Fakultní nemocnice Brno Bohunice

    RECRUITING

    Brno, 625 00, Czechia

  • Flinders Medical Centre

    RECRUITING

    Adelaide, 5042, Australia

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

    RECRUITING

    Roma, 00168, Italy

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • G. Papanikolaou General Hospital

    RECRUITING

    Thessaloniki, 570 10, Greece

  • General Hospital of Athens "Laiko"

    RECRUITING

    Αthens, 11526, Greece

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

    RECRUITING

    Mulhouse, 68100, France

  • Groupe Jolimont

    RECRUITING

    La Louvière, 7100, Belgium

  • Gulfport Memorial Hospital

    RECRUITING

    Gulfport, Mississippi, 39501, United States

  • Hammersmith Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • Heartlands Hospital

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Costa del Sol

    RECRUITING

    Marbella, 29603, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, 28031, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • ICON Cancer Centre - Kurralta Park

    RECRUITING

    Kurralta Park, 5037, Australia

  • IN VIVO

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • InVO Institut für Versorgungsforschung in der Onkologie

    RECRUITING

    Koblenz, 56068, Germany

  • Institut Català d'Oncologia - L'Hospitalet

    RECRUITING

    L'Hospitalet Del Llobregat, 08908, Spain

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Institutul Oncologic Cluj

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie

    RECRUITING

    Iași, 700483, Romania

  • Ironwood Cancer & Research Centers

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Klinikum Aschaffenburg-Alzenau

    RECRUITING

    Hösbach, 63768, Germany

  • Kocaeli Üniversitesi

    RECRUITING

    İzmit, 41380, Turkey (Türkiye)

  • Latrobe Regional Health

    RECRUITING

    Traralgon, 3844, Australia

  • Lincoln County Hospital

    RECRUITING

    Lincoln, LN2 5QY, United Kingdom

  • MD Anderson Cancer Center

    RECRUITING

    Madrid, 28033, Spain

  • MV-Zentrum für Onkologie und Hämatologie

    RECRUITING

    Cologne, 50677, Germany

  • Maidstone Hospital

    RECRUITING

    Maidstone, ME16 9QQ, United Kingdom

  • Memorial Antalya Hospital

    RECRUITING

    Antalya, 07090, Turkey (Türkiye)

  • Mission Cancer + Blood

    RECRUITING

    Waukee, Iowa, 50263, United States

  • Narodny onkologicky ustav

    RECRUITING

    Bratislava, 833 10, Slovakia

  • Northwick Park Hospital

    RECRUITING

    Harrow, HA1 3UJ, United Kingdom

  • OSP Göttingen

    RECRUITING

    Göttingen, 37073, Germany

  • Odense Universitetshospital

    RECRUITING

    Odense, 5000, Denmark

  • Ondokuz Mayıs Universitesi

    RECRUITING

    Samsun, 55139, Turkey (Türkiye)

  • Onkologisches Ambulanzzentrum Hannover

    RECRUITING

    Hanover, 30171, Germany

  • Ovidius Clinical Hospital OCH

    RECRUITING

    Ovidiu, 905900, Romania

  • Palo Alto Medical Foundation Research Institute (PAMFRI)

    RECRUITING

    Palo Alto, California, 94304, United States

  • Pratia MCM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-519, Poland

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, 4102, Australia

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • Pécsi Tudományegyetem Klinikai Központ

    RECRUITING

    Pécs, 7624, Hungary

  • Rocky Mountain Cancer Center

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Royal Hobart Hospital

    RECRUITING

    Hobart, 7000, Australia

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, L4M 6M2, Canada

  • Saint Elizabeth Medical Center Edgewood

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Sakarya University School of Medicine

    RECRUITING

    Adapazarı, 54100, Turkey (Türkiye)

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute/SCRI

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, S7N4H4, Canada

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1088, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Singleton Hospital

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • Spitalul Clinic Colțea

    RECRUITING

    Bucharest, 030171, Romania

  • Spitalul Clinic Municipal Filantropia Craiova

    RECRUITING

    Craiova, 200143, Romania

  • St James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Stanford Cancer Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    RECRUITING

    Szeged, 6725, Hungary

  • The Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

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

    RECRUITING

    Seoul, 06591, South Korea

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

    RECRUITING

    Seoul, 07345, South Korea

  • The Perth Blood Institute - West Perth

    RECRUITING

    West Perth, 6005, Australia

  • The West Clinic, PLLC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • USO-Texas Oncology-Central/South Texas

    RECRUITING

    Austin, Texas, 78705, United States

  • USO-Virginia Oncology Associates

    RECRUITING

    Hampton, Virginia, 23666, United States

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • Univerzitna Nemocnica L. Pasteura Kosice

    RECRUITING

    Košice, 040 11, Slovakia

  • Univerzitna nemocnica Martin

    RECRUITING

    Martin, 036 59, Slovakia

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

    RECRUITING

    Wroclaw, 50-367, Poland

  • VM Medical Park Mersin Hastanesi

    RECRUITING

    Mersin, 33200, Turkey (Türkiye)

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12808, Czechia

  • Williamette Valley Cancer Institute & Research Center

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Yeditepe Üniversitesi Koşuyolu Hastanesi

    RECRUITING

    Istanbul, 34718, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.