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New pill shows promise for Hard-to-Treat blood cancers

NCT ID NCT03740529

Disease control Sponsor: Loxo Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an oral drug called LOXO-305 (pirtobrutinib) in 803 people with chronic lymphocytic leukemia, small lymphocytic lymphoma, or other non-Hodgkin lymphomas whose cancer had stopped responding to or could not tolerate standard treatments. The goal was to find the best dose and see if the drug could shrink tumors. The drug works by blocking a protein that helps cancer cells grow, and it is taken daily as a pill.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

803 people

The number who actually took part.

Started

Mar 2019

Finished

Dec 2025

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: * Histologically confirmed CLL/SLL, WM, or NHL intolerant to either ≥ 2 prior standard of care regimens given in combination or sequentially OR have received 1 prior BTK inhibitor-containing regimen when a BTK inhibitor is approved as first line therapy (Phase 1) OR with prior treatment defined by phase 2 cohort (Phase 2 Patients only). * Adequate hematologic function (Phase 1 and 1b Patients only). * Responsive to transfusion support if given for thrombocytopenia or anemia (Phase 1 and 1b Patients only). * Histologically confirmed relapsed/recurrent CLL in whom venetoclax is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm A Patients only). * Histologically confirmed relapsed/refractory CLL in whom venetoclax + rituximab is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm B Patients only). * Eastern Cooperative Oncology Group (ECOG) 0-2. * Adequate hepatic and renal function. * Ability to receive study drug therapy orally. * Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control. Exclusion Criteria: * Investigational agent or anticancer therapy within 5 half-lives or 14 days, whichever is shorter, prior to planned start of specified study therapy except antineoplastic and immunosuppressant monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to the first dose of pirtobrutinib. In addition, no concurrent systemic anticancer therapy is permitted. * Major surgery within 4 weeks prior to planned start of specified study therapy. * Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment. * Pregnancy or lactation. * Patients requiring therapeutic anticoagulation with warfarin. * Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 or greater at the time of starting study treatment except for alopecia. * History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days (180 days before the PK trigger) prior to planned start of specified study therapy. * Known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible and enrolled to phase 2 Cohort 7 if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval. * Active uncontrolled auto-immune cytopenia where new therapy introduced or concomitant therapy escalated within the 4 weeks prior to study enrollment is required to maintain adequate blood counts. * Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of pirtobrutinib. * Active uncontrolled systemic bacterial, viral, fungal or parasitic infection. * Patients who have tested positive for human immunodeficiency virus (HIV) are excluded. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment. * Clinically significant active malabsorption syndrome. * Current treatment with certain strong CYP3A4 inhibitors or inducers and/or strong P-gp inhibitors. * For patients enrolled to phase 1b Arm A or B: Patients with prior treatment with venetoclax or other BCL-2 inhibitors. * Prior treatment with pirtobrutinib. * Active second malignancy unless in remission and with life expectancy \> 2 years. * Known hypersensitivity to any component or excipient of pirtobrutinib. * For patients enrolled to phase 1b Arm B: Patients with prior significant hypersensitivity, allergy, or anaphylactic reaction to rituximab/biosimilar requiring discontinuation. * Patients with prior significant hypersensitivity to rituximab requiring discontinuation, prior allergic or anaphylactic reaction to rituximab (Phase 1b Arm B Patients only).

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm follicular lymphoma interdigitating dendritic cell sarcoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

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

B-cell lymphoma Chronic lymphocytic leukemia Mantle cell lymphoma Marginal zone lymphoma Small lymphocytic lymphoma Waldenstrom macroglobulinemia

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093, France

  • Churchill Hospital

    Oxford, OX3 7LJ, United Kingdom

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Derriford Hospital

    Plymouth, Pl6 8DH, United Kingdom

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Durham VA Medical Center

    Durham, North Carolina, 27705, United States

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Florida Cancer Specialists ORLANDO/DDU

    Lake Mary, Florida, 32746, United States

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • IRCCS - AOU di Bologna

    Bologna, 40138, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Instytut Hermatologii I Transfuzjologii

    Warsaw, Poland

  • Karolinska Institutet

    Solna, AB, 171 65, Sweden

  • Kindai University Hospital

    Osakasayama-Shi, 589-8511, Japan

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505, Japan

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566, Japan

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905-0002, United States

  • Mayo Clinic of Scottsdale

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203, United States

  • Scripps Coastal Medical Center

    San Diego, California, 92103, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98195, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510, United States

  • St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokai University Hospital- Isehara Campus

    Isehara, Kanagawa, 259-1193, Japan

  • University of California San Francisco, Medical Center at Paranassus

    San Francisco, California, 94117, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

More trials for these conditions

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