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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06876649




Registration number
NCT06876649
Ethics application status
Date submitted
6/03/2025
Date registered
14/03/2025

Titles & IDs
Public title
A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
Scientific title
A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Secondary ID [1] 0 0
J2N-MC-JZNY
Secondary ID [2] 0 0
27202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pirtobrutinib

Experimental: JZ01 Pirtobrutinib - Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA).

Pirtobrutinib administered orally.


Treatment: Drugs: Pirtobrutinib
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with a Grade =3 treatment-emergent AEs
Assessment method [1] 0 0
Timepoint [1] 0 0
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 outcome [1] 0 0
Overall Survival
Assessment method [1] 0 0
Overall survival is defined as the time from enrollment from the originator study until death from any cause
Timepoint [1] 0 0
Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)

Eligibility
Key inclusion criteria
* Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2032
Actual
Sample size
Target
279
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Victoria
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3000 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
France
State/province [16] 0 0
Loire Atlantique
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardia
Country [18] 0 0
Italy
State/province [18] 0 0
Bologna
Country [19] 0 0
Japan
State/province [19] 0 0
Kanagawa
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo
Country [21] 0 0
Japan
State/province [21] 0 0
Aichi-Ken
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Miyagi-Ken
Country [24] 0 0
Japan
State/province [24] 0 0
Sapporoshi
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Korea
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Poland
State/province [27] 0 0
Krakow
Country [28] 0 0
Poland
State/province [28] 0 0
Warsaw
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Devon
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Oxfordshire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Email 0 0
clinical_inquiry_hub@lilly.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06876649