Leukemia, Lymphocytic, Chronic, B-CellNCT05172700
Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
A study testing Pirtobrutinib in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Lymphocytic, Small, run by Loxo Oncology, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell
- What is being tested?
- Pirtobrutinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
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.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Ritcher's Transformation, Syndrome
- Being tested
- Pirtobrutinib
- Keywords
- BTKi, BTK Inhibitor, Bruton's tyrosine kinase inhibitor, Hematologic Disease, B-cell receptor
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Syndrome, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirtobrutinibDrug
Also called LY3527727, LOXO-305
Administered orally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Loxo Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172700
- Sponsor's protocol ID
- 17712
- Other IDs
- J2N-OX-Y001
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
- ClinicalTrials.gov ID
- NCT05172700
- Acronym / sponsor ID
- 17712
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Ritcher's Transformation, Syndrome
- Keywords
- BTKi, BTK Inhibitor, Bruton's tyrosine kinase inhibitor, Hematologic Disease, B-cell receptor
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Loxo Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 29 Dec 2021 (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.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have been diagnosed with:
- Are not eligible for an ongoing pirtobrutinib clinical trial
Key exclusion criteria (7 listed)
- 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
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: LY3527727, LOXO-305Administered orally. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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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. This study is not recruiting at the moment.
Contact Lilly at 1-800-LillyRx (1-800-545-5979) study director
Eli Lilly and Company
Questions about this trial
What is this clinical trial studying?
A study testing Pirtobrutinib in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Lymphocytic, Small, run by Loxo Oncology, Inc..
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Dec 2024.