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New pill shows promise for Hard-to-Treat leukemia and lymphoma

NCT ID NCT04849416

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested an oral drug called pirtobrutinib in 87 Chinese adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma who had already received standard treatments. The goal was to see how well the drug shrank tumors and to check for side effects. Participation lasted up to four years. Results showed that some participants responded to the drug, offering hope for those who have run out of options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pirtobrutinib (also called LOXO-305), an oral targeted therapy
What this could lead to
If successful, this could offer a new treatment option for people with certain blood cancers who have stopped responding to other therapies.
What could go wrong
This is a phase 2 study with a small number of participants (87) and no comparison group. Results may not apply to all patients, and side effects are still being evaluated.

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

87 people

The number who actually took part.

Started

May 2021

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 * Participants with histologically confirmed B-cell malignancy including: * Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen; * CLL/SLL treated with a prior BTK inhibitor containing regimen; * Other types of B-cell NHL * All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required * Eastern Cooperative Oncology Group 0-2 * Adequate hematologic status, coagulation, hepatic and renal function Exclusion Criteria * Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment * Participants requiring therapeutic anticoagulation with warfarin * Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded * Significant cardiovascular disease * Prolongation of the QT interval * Test positive for human immunodeficiency virus (HIV) * Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors * Pregnancy or lactation * Active second malignancy * Prior treatment with LOXO-305 * Known hypersensitivity to any component or excipient of LOXO-305

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm B-cell non-Hodgkin lymphoma chronic lymphocytic leukemia/small lymphocytic lymphoma diffuse large B-cell lymphoma lymphoid leukemia Lymphoma, B-Cell, Marginal Zone lymphoma, non-Hodgkin, familial mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Leukemia, lymphocytic, chronic, B-cell Leukemia, lymphoid Lymphoma, B-cell Lymphoma, B-cell marginal zone Lymphoma, large B-cell, diffuse Lymphoma, mantle cell Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 71066, China

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142, China

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 300020, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000, China

  • Shanghai East Hospital

    Shanghai, 200120, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 511400, China

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan, 471003, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215066, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001, China

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710126, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Xingtai People's Hospital

    Xingtai, Hebei, 054031, China

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830000, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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