Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06876649

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

Led by Eli Lilly and Company · Updated on 2026-03-02

787

Participants Needed

38

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a master protocol study to evaluate the long-term safety and efficacy of the drug pirtobrutinib in patients who have completed previous clinical studies involving this medication. This study includes participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma and aims to monitor their health over an extended period. The master protocol organizes individual study-specific appendices (ISAs) representing participants from earlier originator studies. Participants continue to receive pirtobrutinib as they did in their original clinical study, with the drug administered orally. The study allows these individuals to keep taking the treatment or to continue with follow-up visits under this master protocol framework. The study is designed to gather safety and survival data over many years. During the study, participants will be closely monitored for any serious treatment-related side effects, with assessments focused on adverse events occurring from the first dose until shortly after the last dose or when starting a new anticancer therapy. Researchers will also track overall survival for up to 93 months. This long-term follow-up ensures comprehensive safety and health evaluations throughout the participant's involvement, which may last several years.

CONDITIONS

Brief Title

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Not Eligible

You will not qualify if you...

  • Exclusion criteria are defined in each ISA.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From first dose until discontinuation or start of new anticancer therapy

Participants receive pirtobrutinib orally as defined in the originator study.

Regular visits as per originator study schedule

Follow-up

Duration - Up to 30 days after last dose or start of new anticancer therapy, and overall survival monitored up to 93 months

Participants are monitored for safety and overall survival after treatment ends.

Visits for safety monitoring and survival follow-up as scheduled

Trial Site Locations

Total: 38 locations

1

Cancer Specialists, LLC

Jacksonville, Florida, United States, 32256

Not Yet Recruiting

2

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136-1002

Actively Recruiting

3

Florida Cancer Specialists

Sarasota, Florida, United States, 34232-6422

Actively Recruiting

4

The Emory Clinic

Atlanta, Georgia, United States, 30322-1013

Not Yet Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611-3013

Not Yet Recruiting

6

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

Mayo Clinic- Minnesota

Rochester, Minnesota, United States, 55905

Actively Recruiting

8

University Of Nebraska Medical Center

Omaha, Nebraska, United States, 69198

Actively Recruiting

9

Cayuga Cancer Center

Ithaca, New York, United States, 14850

Actively Recruiting

10

Northwell Health

Lake Success, New York, United States, 11042-1118

Actively Recruiting

11

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, United States, 10065-6007

Actively Recruiting

12

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, United States, 10065-6007

Not Yet Recruiting

13

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, United States, 10065-6007

Not Yet Recruiting

14

Duke University Medical Center

Durham, North Carolina, United States, 27710-4000

Actively Recruiting

15

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210-1063

Actively Recruiting

16

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

17

Tennessee Oncology

Nashville, Tennessee, United States, 37203-2659

Actively Recruiting

18

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

19

Swedish Cancer Institute

Seattle, Washington, United States, 98104-3588

Actively Recruiting

20

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226-3548

Actively Recruiting

21

Flinders Medical Centre

Adelaide, Australia, 5042

Actively Recruiting

22

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

Actively Recruiting

23

Linear Clinical Research

Victoria, Australia, 3000

Actively Recruiting

24

CHU de Nantes - Hotel Dieu

Nantes, France, 44093

Actively Recruiting

25

IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Actively Recruiting

26

Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

27

Nagoya Medical Center

Aichi-Ken, Japan, 4600001

Actively Recruiting

28

National Cancer Center Hospital

Cho-ku, Japan, 104-0045

Actively Recruiting

29

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan, 811-1395

Actively Recruiting

30

Tokai University Hospital- Isehara Campus

Isehara, Japan, 259-1193

Actively Recruiting

31

Tohoku University Hospital

Miyagi-Ken, Japan, 9808574

Actively Recruiting

32

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Actively Recruiting

33

Pratia MCM Krakow

Krakow, Poland, 30727

Actively Recruiting

34

Instytut Hermatologii I Transfuzjologii

Warsaw, Poland, 02776

Actively Recruiting

35

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

36

St James's University Hospital

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

37

Churchill Hospital

Oxford, United Kingdom, OX3 7LE

Not Yet Recruiting

38

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

P

Physicians interested in becoming principal investigators please contact

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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