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Leukemia, LymphoidPhase 2NCT04849416

A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

A Phase 2 study testing LOXO-305 in people with Leukemia, Lymphoid and Lymphoma, Non-Hodgkin, run by Eli Lilly and Company at 22 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LOXO-305
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
22 sitesChina
Study dates
14 May 2021to 29 Dec 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 71066

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 511400

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

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

    Luoyang Shi, Henan, 471003

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

    Nanjing, Jiangsu, 210000

  • Shanghai East Hospital

    Shanghai, 200120

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215066

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830000

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710126

  • Xingtai People's Hospital

    Xingtai, Hebei, 054031

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase 2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.

Being tested
LOXO-305
Medical subject headings
Leukemia, Lymphoid, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • LOXO-305Drug

    Also called LY3527727, Pirtobrutinib

    Administered orally.

Study groups in NCT04849416
Study groupRoleWhat they receive
LOXO-305ExperimentalParticipants received 200 mg of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
Receives: Drug: LOXO-305

What is being measured

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

  1. Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee

    ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.

    Measured: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

Secondary outcomes (8)

  1. PAS ORR: ORR Assessed by Investigator

    ORR was assessed by the Investigator. It was estimated based on the percentage of participants with BOR of CR or PR. Two-sided 95% CI was calculated using the exact binomial distribution.

    Measured: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

  2. PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)

    BOR was assessed by the IRC and Investigator. Best overall assessment categories include (in descending order of extent of response): CR, PR, SD, PD, and NE. Two-sided 95% CI was calculated using the exact binomial distribution.

    Measured: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)

  3. PAS: Duration of Response (DOR)

    DOR was assessed by the Investigator and IRC. DOR is defined as the number of months from the date of the first documented response to the date of PD or death, whichever occurs earlier. Participants who are alive and without documented PD as of data analysis cutoff date will be censored.

    Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks)

  4. PAS: Progression Free Survival (PFS)

    PFS was assessed by the IRC and Investigator. PFS is defined as the number of months from the date of the first dose of study drug to the earlier of documented PD or death due to any cause. Participants who are alive and without documented PD as of data analysis cutoff date were censored.

    Measured: Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks)

  5. PAS: Overall Survival (OS)

    OS is defined as the number of months elapsed between the date of the first dose of study drug and the date of death from any cause. Participants who are alive or lost to follow-up as of the data cutoff date will be censored.

    Measured: Date of First Dose to Date of Death from Any Cause (Up to 100 weeks)

  6. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305

    PK: AUC[0-tlast] of LOXO-305

    Measured: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.

  7. PK: Maximum Concentration (Cmax) of LOXO-305

    PK: Cmax of LOXO-305

    Measured: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.

  8. PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.

    Measured: Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks)

Timeline

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

  1. First posted19 Apr 2021
  2. Study start14 May 2021
  3. Primary completion10 Apr 2023
  4. Study completion29 Dec 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849416
Sponsor's protocol ID
17746
Other IDs
J2N-MC-JZNJ
Status last verified
Aug 2025
First submitted
16 Apr 2021
Last updated
6 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Liu Y, Lin N, Yi S, Huang H, Guo Y, Zhang Q, Yang H, Zhang H, Zhang L, Feng R, Qian Y, Zhu J, Song Y, Zhu J. Pirtobrutinib in Chinese patients with relapsed or refractory B-cell malignancies: A single-arm, open-label, phase 2, multicenter trial. Int J Cancer. 2025 Jun 1;156(11):2158-2168. doi: 10.1002/ijc.35339. Epub 2025 Feb 28.

    PubMed 40018797

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LOXO-305 in people with Leukemia, Lymphoid and Lymphoma, Non-Hodgkin, run by Eli Lilly and Company at 22 sites in China.

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 7 inclusion and 11 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. 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?

Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee (time frame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)). 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 NCT04849416, which also lists 1 linked publication.

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 6 Feb 2026.

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