Chronic Lymphocytic LeukemiaPhase 4NCT06876662
A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
A Phase 4 study testing Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, run by Eli Lilly and Company at 36 sites in 8 countries.
Trial summary
Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Non-Hodgkin 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
- 279 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 20 May 2025to Dec 2032
- Phase
- Phase 4
- 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
- Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are:
- receiving study intervention
- in the short-term follow-up period, or
- in the long-term follow-up period
Who cannot join
- Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001
Trial locations and contacts
36 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
36 sites in 8 countries
United States18 sites, 16 recruiting
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30322-1013
404-778-3708
Jonathon Cohen
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
617-632-5847
Jennifer Brown
- Recruiting
Northwestern University
Chicago, Illinois, 60611-3013
312-908-5250
Shuo Ma
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1063
614-293-3196
Jennifer Woyach
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710-4000
919-684-8111
Matthew McKinney
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
713-792-2860
Michael Wang
- Active, not recruiting
Cayuga Cancer Center
Ithaca, New York, 14850
- Recruiting
Northwell Health
Lake Success, New York, 11042-1118
516-734-8959
Steven Allen
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002
954-265-6549
Alvaro Alencar
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548
414-805-4600
Nirav Shah
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203-2659
615-524-4074
Michael Byrne
- Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
646-608-4273
Prioty Islam
- Active, not recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
- Recruiting
University Of Nebraska Medical Center
Omaha, Nebraska, 69198
402-559-5166
Matthew Lunning
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
215-662-3933
Sunita Nasta
- Recruiting
Mayo Clinic- Minnesota
Rochester, Minnesota, 55905
507-284-2511
Yucai Wang
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232-6422
941-377-9993
Manish Patel
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104-3588
908-208-4685
Swathi Namburi
Japan6 sites
- Active, not recruiting
Nagoya Medical Center
Aichi-Ken, 4600001
- Completed
National Cancer Center Hospital
Cho-ku, 104-0045
- Active, not recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Active, not recruiting
Tokai University Hospital- Isehara Campus
Isehara, 259-1193
- Active, not recruiting
Tohoku University Hospital
Miyagi-Ken, 9808574
- Active, not recruiting
Hokkaido University Hospital
Sapporo, 060-8648
Australia3 sites, 1 recruiting
- Recruiting
Flinders Medical Centre
Adelaide, 5042
+61882044018
Hui-Peng Lee
- Completed
Peter MacCallum Cancer Centre
Melbourne, 3000
- Active, not recruiting
Linear Clinical Research
Victoria, 3000
United Kingdom3 sites, 3 recruiting
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
+441132433144
Talha Munir
- Recruiting
Churchill Hospital
Oxford, OX3 7LE
+447728268414
Toby Eyre
- Recruiting
Derriford Hospital
Plymouth, PL6 8DH
+441752431043
David John Lewis
Italy2 sites, 1 recruiting
- Completed
IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
Bologna, 40138
- Recruiting
Ospedale San Raffaele
Milan, 20132
+390226434797
Paolo Ghia
Poland2 sites, 2 recruiting
- Recruiting
Pratia MCM Krakow
Krakow, 30727
+48124003200
Wojciech Jurczak
- Recruiting
Instytut Hermatologii I Transfuzjologii
Warsaw, 02-776
+48223496334
Ewa Lech-Maranda
France1 site, 1 recruiting
- Recruiting
CHU de Nantes - Hotel Dieu
Nantes, 44093
+33240083271
Thomas Gastinne
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
+821071243234
Ja Min Byun
About this study
Official title: Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.
- Conditions
- Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
- Being tested
- Pirtobrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
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 |
|---|---|---|
| JZ01 Pirtobrutinib | Experimental | Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA).
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 a Grade ≥3 treatment-emergent adverse events (TEAEs)
Measured: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier
Secondary outcomes (1)
Overall Survival
Overall survival is defined as the time from enrollment from the originator study until death from any cause
Measured: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start20 May 2025
- Primary completionMay 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 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
- NCT06876662
- Sponsor's protocol ID
- 27289
- Other IDs
- 2024-517760-29-00, J2N-MC-JZ01, J2N-MC-JZNY
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2025
- Last updated
- 2 Mar 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 2 Mar 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 LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06876662
- Acronym / sponsor ID
- 27289
- Conditions
- Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 Mar 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.
Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JZ01 Pirtobrutinib | Experimental | Drug: PirtobrutinibParticipants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are:
Key exclusion criteria (1 listed)
- Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001
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 | JZ01 Pirtobrutinib |
Primary outcome
Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs)
Time frame: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier
1 secondary outcome
Overall Survival
Time frame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
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 2 Mar 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 Chronic Lymphocytic Leukemia
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Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
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RecruitingObservational study
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pirtobrutinib in people with Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, run by Eli Lilly and Company at 36 sites in 8 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Japan, Australia, United Kingdom, Italy and 3 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs) (time frame: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier). 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 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.