Chronic Lymphocytic LeukemiaPhase 4NCT07218341
A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase 4 study testing Pirtobrutinib and Idelalisib in people with Chronic Lymphocytic Leukemia and Lymphoma, Small Lymphocytic, run by Eli Lilly and Company at 50 sites in 17 countries.
Trial summary
This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic
- What is being tested?
- Pirtobrutinib and Idelalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 50 sitesin 17 countries
- Study dates
- 9 Mar 2026to Dec 2032
- Phase
- Phase 4
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 actively participating in study J2N-MC-JZNN/LOXO-BTK-20020
Who cannot join
- This is not applicable to this study
Trial locations and contacts
50 sites in 17 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
50 sites in 17 countries
China13 sites, 13 recruiting
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, 100053
+8613691066953
Wuhan Hui
- Not yet recruiting
Hunan Cancer Hospital
Changsha, 410013
Hui Zhou
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangdong, 510060
+8613798032244
He Huang
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, 510515
+8613725119762
RU FENG
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, 730050
+8613519607327
Jie Cui
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
+86079188693682
Fei Li
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
+862164175590
Junning Cao
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, 317000
+8613515861286
Qunyi Guo
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, 300020
+8622023909015
Rui Lv
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
+8618622221227
Lihua Qiu
- Not yet recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830000
+869917968088
Shune Yang
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221000
+86516085802297
Jiang Cao
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, 450003
+864000371818
Keshu Zhou
United States9 sites, 9 recruiting
- Not yet recruiting
Oncology Hematology Care Inc
Cincinnati, Ohio, 45211
513-751-2273
Kruti Patel
- Recruiting
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
612-884-6300
Avina Singh
- Not yet recruiting
Texas Oncology - Paris
Fort Worth, Texas, 76104
214-370-1000
Harris Naina
- Not yet recruiting
Cayuga Cancer Center
Ithaca, New York, 14850
Cynthia Davis
- Recruiting
Cancer Specialists, LLC
Jacksonville, Florida, 32256
904-538-4488
Ayed Ayed
- Not yet recruiting
US Oncology - Texas Oncology
Kyle, Texas, 78640
210-595-5300
David Friedman
- Recruiting
Mitchell Cancer Institute
Mobile, Alabama, 36693
334-660-5108
Anita Mazloom
- Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
646-608-4273
Prioty Islam
- Not yet recruiting
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, 85711
520-886-0206
Sudhir Manda
Italy7 sites, 7 recruiting
- Not yet recruiting
Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
+390131207825
Gioacchino Catania
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
+39557947958
alessandro sanna
- Not yet recruiting
Presidio Ospedaliero Papardo
Messina, 98158
+39903992246
Donato Mannina
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
+390392331
Carlo Gambacorti-Passerini
- Not yet recruiting
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, 06129
+39755783990
PAOLO SPORTOLETTI
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00138
+390630156016
LUCA LAURENTI
- Not yet recruiting
Azienda Ospedaliera S. Maria Di Terni
Terni, 05100
+39744205971
Arcangelo Liso
Poland3 sites, 3 recruiting
- Not yet recruiting
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
Brzozów, 36-200
+48134309728
Jacek Krzanowski
- Not yet recruiting
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, 85-168
+48795149026
Marta Sobas
- Not yet recruiting
Pratia Onkologia Katowice
Katowice, 40-519
+48600388282
Sebastian Grosicki
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Castle Hill Hospital
Hull, HU16 5JQ
+441482461296
David Allsup
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
+441132433144
Talha Munir
- Not yet recruiting
GenesisCare
Newmarket, CB8 7XN
+44 1223 816789
George Follows
Hungary2 sites, 2 recruiting
- Not yet recruiting
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097
+3614558217
Zoltan Matrai
- Not yet recruiting
Debreceni Egyetem
Debrecen, 4032
+3652255196
Illes Arpad
Ireland2 sites, 2 recruiting
- Not yet recruiting
St. James's Hospital
Dublin, D08 NHY1
+353868703651
Carmel Waldron
- Not yet recruiting
Beaumont Hospital
Dublin, DUBLIN 9
+35318092010
Philip Murphy
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitario Marques De Valdecilla
Santander, 39008
+34942202520
LUCRECIA YANEZ SAN SEGUNDO
- Not yet recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41010
+34955013277
Fatima de la Cruz Vicente
Australia1 site, 1 recruiting
- Not yet recruiting
The Alfred Hospital
Melbourne, 3004
61396561111
Constantine Tam
Austria1 site, 1 recruiting
- Not yet recruiting
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020
+435725525822
Alexander Egle
Belgium1 site, 1 recruiting
- Not yet recruiting
AZ Delta
Roeselare, 8800
+3251237322
Lien Deleu
Canada1 site, 1 recruiting
- Not yet recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, M5G 2M9
4169462827
Christine Chen
Croatia1 site, 1 recruiting
- Not yet recruiting
University Hospital Center Zagreb
Zagreb, 10000
+38512388675
Igor Aurer
Czechia1 site, 1 recruiting
- Not yet recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
+420495834851
Martin Simkovic
France1 site, 1 recruiting
- Not yet recruiting
Centre Henri Becquerel
Rouen, 76038
+33232082223
Stephane Lepretre
Israel1 site, 1 recruiting
- Not yet recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
97236973576
Yair Herishanu
Japan1 site, 1 recruiting
- Recruiting
Tokai University Hospital
Isehara, 259-1193
81120023812
Yoshiaki Ogawa
About this study
Official title: Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.
- Being tested
- Pirtobrutinib, Idelalisib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirtobrutinibDrug
Also called LY3527727
Administered orally
IdelalisibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Pirtobrutinib (Arm A) | Experimental | Participants receive pirtobrutinib orally Receives: Drug: Pirtobrutinib |
| Idelalisib (Arm B) | Experimental | Participants receive idelalisib orally Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
Measured: Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier
Secondary outcomes (1)
Overall Survival
Overall survival is defined as the time from randomization in a randomized originator study, or from the first dose in a non-randomized originator study, until death from any cause
Measured: Time from Enrollment in 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 posted20 Oct 2025
- Study start9 Mar 2026
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT07218341
- Sponsor's protocol ID
- 27296
- Other IDs
- J2N-MC-JZ03, J2N-MC-JZNY
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2025
- Last updated
- 22 Sep 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