Lymphoma, Non-HodgkinPhase 2NCT07162181
Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers
A Phase 2 study testing Pirtobrutinib in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Eli Lilly and Company at 6 sites in China.
Trial summary
The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer. Participants must have chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkins lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, B-cell Lymphoma
- 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
- 13 participants
- Where
- 6 sitesChina
- Study dates
- 7 Aug 2025to May 2030
- 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
- Currently enrolled and active in the originator study, JZNJ. A participant is considered active in the study if they are receiving study intervention
- Agree to comply with contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Who cannot join
- Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Cancer hospital
Beijing, 100142
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Harbin Medical University Cancer Hospital
Harbin, 150081
Shanghai East Hospital
Shanghai, 200123
Blood Institute of the Chinese Academy of Medical science
Tianjin, 300020
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
About this study
Official title: Long-Term Safety of Pirtobrutinib in Participants From Study J2N-MC-JZNJ With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer. Participants must have chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkins lymphoma. The study is open to those who completed the original study - J2N-MC-JZNJ (NCT04849416) and continue to benefit from treatment. Treatment will be given every 12 weeks and this study is expected to last about 5 years.
- Being tested
- Pirtobrutinib
- Keywords
- Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirtobrutinibDrug
Also called Loxo-305, LY3527727
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Pirtobrutinib | Experimental | Pirtobrutinib administered orally. Receives: Drug: Pirtobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
Measured: Day 1 through 28 days after last dose or start of new anticancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start7 Aug 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162181
- Sponsor's protocol ID
- 27295
- Other IDs
- J2N-MC-JZ02, 2024-517760-29-00, J2N-MC-JZNY, J2N-MC-JZNJ
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2025
- Last updated
- 17 Apr 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety of Pirtobrutinib in Participants From Study J2N-MC-JZNJ With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07162181
- Acronym / sponsor ID
- 27295
- Keywords
- Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer. Participants must have chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkins lymphoma. The study is open to those who completed the original study - J2N-MC-JZNJ (NCT04849416) and continue to benefit from treatment. Treatment will be given every 12 weeks and this study is expected to last about 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirtobrutinib | Experimental | Drug: PirtobrutinibPirtobrutinib administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently enrolled and active in the originator study, JZNJ. A participant is considered active in the study if they are receiving study intervention
- Agree to comply with contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Key exclusion criteria (1 listed)
- Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirtobrutinibAlso: Loxo-305, LY3527727Administered orally. | Drug | Pirtobrutinib |
Primary outcome
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
Time frame: Day 1 through 28 days after last dose or start of new anticancer therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: 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.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirtobrutinib in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Eli Lilly and Company at 6 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
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?
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events (time frame: Day 1 through 28 days after last dose or start of new anticancer therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.