Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05172700




Registration number
NCT05172700
Ethics application status
Date submitted
15/12/2021
Date registered
29/12/2021
Date last updated
23/10/2023

Titles & IDs
Public title
Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
Scientific title
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
Secondary ID [1] 0 0
J2N-OX-Y001
Secondary ID [2] 0 0
17712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic, B-Cell 0 0
Lymphoma, Lymphocytic, Small 0 0
Lymphoma, Mantle-Cell 0 0
Waldenstrom Macroglobulinemia 0 0
Ritcher's Transformation, Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

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

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

Outcomes

Eligibility
Key inclusion criteria
- Have been diagnosed with:

- CLL or SLL and have received treatment with the following five classes of
therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody,
covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2)
inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor

- MCL that has been previously treated with a covalent BTK inhibitor

- Richter's Transformation (RT) with previous Richter's directed-therapy

- Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy,
anti-CD20 antibody and a covalent BTK inhibitor

- Are not eligible for an ongoing pirtobrutinib clinical trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Inadequate organ function

- Significant cardiovascular disease

- History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen
receptor modified Tcell (CAR-T) therapy within 60 days

- Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B
or C virus or cytomegalovirus (CMV) infection

- Active, uncontrolled autoimmune cytopenia

- Clinically significant active malabsorption syndrome

- Participants requiring therapeutic anticoagulation with warfarin or another vitamin K
antagonist

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Loxo Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an expanded access program for eligible participants with a previously treated B-cell
cancer who are ineligible for an ongoing pirtobrutinib clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a
patient meets the criteria for inclusion in the expanded access program.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05172700
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
In the U.S., physicians seeking help on behalf of their patients may contact Lilly at
Address 0 0
Country 0 0
Phone 0 0
1-800-LillyRx (1-800-545-5979)
Fax 0 0
Email 0 0
Clinicaltrials.gov@lilly.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05172700