Pirtobrutinib for Lymphoma

Recruiting at 49 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

787 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on the long-term safety and effectiveness of pirtobrutinib for individuals with lymphoma, a cancer affecting the immune system. Participants from earlier studies on pirtobrutinib can continue receiving this treatment or attend follow-up visits. The trial aims to gather more information on pirtobrutinib's long-term effectiveness. It is best suited for those who participated in previous studies involving pirtobrutinib. As a Phase 4 trial, this research helps determine how the already FDA-approved treatment benefits a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for pirtobrutinib?

Research has shown that pirtobrutinib is generally safe for long-term use. Studies have found it suitable for extended treatment, with most people handling it well without new or worsening side effects. Safety data confirm that pirtobrutinib is well-tolerated, with consistent results across various studies. No major unexpected problems have been reported, making it a good option for those considering treatment for certain blood cancers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Pirtobrutinib is unique because it targets a specific enzyme called Bruton's tyrosine kinase (BTK) in a new way. While most treatments for lymphoma, like ibrutinib and acalabrutinib, also inhibit BTK, pirtobrutinib is designed to bind more precisely and strongly, even when the cancer cells have mutations that make other drugs less effective. Researchers are excited about this treatment because it has the potential to work in patients who have stopped responding to other BTK inhibitors, offering new hope for those with resistant forms of lymphoma.

What is the effectiveness track record for pirtobrutinib in treating lymphoma?

Research has shown that pirtobrutinib, the investigational treatment in this trial, works well for certain types of lymphoma. In cases of relapsed or refractory follicular lymphoma, it helped more than half of the patients by shrinking or eliminating their cancer. For chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), pirtobrutinib proved effective even for patients whose conditions were difficult to treat with previous therapies. In another study, pirtobrutinib, when compared to standard treatments, helped patients live longer without their disease worsening. These findings support its effectiveness in treating different types of lymphoma. ^{6 7 8 9 10}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for patients who are already part of a Lilly sponsored study on pirtobrutinib, which is being tested for lymphoma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma. Participants must have been receiving or eligible to receive pirtobrutinib in the original studies.

Inclusion Criteria

I am already part of a Lilly study for pirtobrutinib.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive pirtobrutinib as defined in the originator study

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 93 months

What Are the Treatments Tested in This Trial?

Interventions

• Pirtobrutinib

Trial Overview The trial evaluates long-term safety and effectiveness of pirtobrutinib after initial clinical trials. It's a continuation protocol allowing participants from completed studies to either keep getting treatment or attend follow-up visits to monitor their health over time.

How Is the Trial Designed?

Group I: JZ01 Pirtobrutinib Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Pilaralisib, a pan-PI3K inhibitor, was found to have an acceptable safety profile in a study of 25 patients with chronic lymphocytic leukemia (CLL) and lymphoma, with common side effects including diarrhea (92%) and pyrexia (52%).

The treatment showed preliminary efficacy, with 50% of CLL patients achieving a partial response and 60% experiencing significant nodal shrinkage, indicating potential for further development in these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Trial of the Pan-PI3K Inhibitor Pilaralisib (SAR245408/XL147) in Patients with Chronic Lymphocytic Leukemia (CLL) or Relapsed/Refractory Lymphoma. Brown, JR., Davids, MS., Rodon, J., et al.[2021]

Pirtobrutinib, a noncovalent Bruton tyrosine kinase inhibitor, has shown high response rates in patients with chronic lymphocytic leukemia and mantle cell lymphoma who are resistant to conventional covalent BTK inhibitors, addressing a significant unmet need in this population.

The early studies indicate that pirtobrutinib has a favorable toxicity profile, suggesting it may be suitable for use in combination therapies, and it has recently received accelerated FDA approval for use in mantle cell lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pirtobrutinib: a new hope for patients with BTK inhibitor-refractory lymphoproliferative disorders. Thompson, PA., Tam, CS.[2023]

Pirtobrutinib, a noncovalent BTK inhibitor, demonstrated a 73.3% overall response rate in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had previously failed covalent BTK inhibitor treatments, indicating its efficacy as a new therapeutic option.

The treatment was generally well-tolerated, with only 2.8% of patients discontinuing due to adverse events, and common side effects included infections and bleeding, while serious side effects like hypertension and major hemorrhage were relatively infrequent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. Mato, AR., Woyach, JA., Brown, JR., et al.[2023]

PI3K inhibitors, including idelalisib, copanlisib, and duvelisib, are FDA-approved for treating relapsed and refractory indolent non-Hodgkin lymphoma, demonstrating their efficacy in managing this type of cancer.

While these agents are effective, their use can lead to significant adverse events, especially when combined with other therapies, highlighting the need for careful monitoring and management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PI3K Inhibitors and Their Role as Novel Agents for Targeted Therapy in Lymphoma. Sapon-Cousineau, V., Sapon-Cousineau, S., Assouline, S.[2021]

Pirtobrutinib received accelerated FDA approval for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior therapies, showing a 50% overall response rate in a study of 120 patients.

While effective, pirtobrutinib has potential side effects including fatigue, diarrhea, and increased risk of infections and bleeding, necessitating postmarketing studies to further assess its long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma. Telaraja, D., Kasamon, YL., Collazo, JS., et al.[2023]

Pirtobrutinib, a novel noncovalent Bruton tyrosine kinase inhibitor, showed a 57.8% overall response rate in patients with relapsed/refractory mantle-cell lymphoma who had previously been treated with covalent BTK inhibitors, indicating its efficacy in a challenging patient population.

The treatment was well tolerated, with only 3% of patients discontinuing due to adverse events, and the most common side effects included fatigue and diarrhea, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pirtobrutinib in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Mantle-Cell Lymphoma. Wang, ML., Jurczak, W., Zinzani, PL., et al.[2023]

Citations

1. ashpublications.org ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2024014975/546861/Pirtobrutinib-a-Highly-Selective-Non-covalent

Pirtobrutinib, a Highly Selective, Non-covalent (Reversible ... Pirtobrutinib demonstrates efficacy in relapsed/refractory follicular lymphoma with an ORR of 52.1% and median DOR of 10.2 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11106640/

Outcomes of pirtobrutinib for relapsed/refractory mantle cell ... Pirtobrutinib shows promising response rates in heavily pretreated MCL patients according to the approval study, but the real‐world data are scarce.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300696

Pirtobrutinib after a Covalent BTK Inhibitor in Chronic ... In this trial, pirtobrutinib showed efficacy in patients with heavily pretreated CLL or SLL who had received a covalent BTK inhibitor.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00166

Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or ... At the prespecified final OS analysis, 18-month OS was 73.4% (95% CI, 63.9 to 80.7) in the pirtobrutinib group and 70.8% (95% CI, 60.9 to 78.7) ...

5. hematologyadvisor.com hematologyadvisor.com/news/pirtobrutinib-improves-pfs-in-treatment-naive-cll-sll-patients/

Pirtobrutinib Improves PFS in Treatment-Naïve CLL/SLL ... Findings showed patients treated with pirtobrutinib had a statistically significant and clinically meaningful improvement in PFS compared with ...

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/6778/528384/The-Real-World-Safety-and-Tolerability-of

The Real-World Safety and Tolerability of Pirtobrutinib Among ... Ten (34.5%) patients had disease progression on pirtobrutinib. Nine (31.0%) patients received pirtobrutinib as part of the bridging therapy to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07162181

Long-Term Safety of Pirtobrutinib in Participants With ... The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.7513

Long-term safety with ≥12 months of pirtobrutinib in ... Conclusions: Prolonged pirtobrutinib therapy continues to demonstrate a safety profile amenable to long-term administration at the recommended ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38824917/

Safety of Extended Pirtobrutinib Exposure in Relapsed and/or ... Pirtobrutinib therapy continues to demonstrate an excellent safety profile amenable to long-term administration without evidence of new or worsening toxicity ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/216059Orig1s000MultidisciplineR.pdf

216059Orig1s000 - accessdata.fda.gov Safety data, across safety analysis sets, demonstrate that pirtobrutinib is well tolerated with a safety profile that is consistent with the ...