Pirtobrutinib for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of pirtobrutinib, a BTK inhibitor, for older patients with chronic lymphocytic leukemia (CLL). BTK inhibitors prevent cancer cell growth, but some patients develop resistance over time. Pirtobrutinib may offer better treatment for CLL in patients without prior treatments. Those living with CLL who have not begun chemotherapy or similar treatments might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that pirtobrutinib is likely to be safe for humans?
Research has shown that pirtobrutinib is generally well-tolerated by patients. In one study, over 70% of patients reported that their quality of life remained stable or improved while taking pirtobrutinib, indicating that the treatment does not worsen everyday symptoms for most people.
However, side effects are common. Another study found that about 93.1% of patients experienced treatment-related side effects, ranging from mild to severe. Despite this, pirtobrutinib maintains a good safety record compared to other treatments, with similar risks of infections and blood-related issues.
Overall, pirtobrutinib appears to be a safe option for treating chronic lymphocytic leukemia, with many patients managing the side effects effectively.12345Why do researchers think this study treatment might be promising for leukemia?
Pirtobrutinib is unique because it targets the Bruton's tyrosine kinase (BTK) enzyme, which plays a crucial role in the survival and spread of leukemia cells. Unlike traditional treatments that may have broader targets or more severe side effects, pirtobrutinib is designed to be more selective, potentially leading to fewer side effects and improved effectiveness. Researchers are excited because this specificity could mean better outcomes for patients who have not responded well to existing therapies, like chemotherapy or other BTK inhibitors, offering a new hope for those battling leukemia.
What evidence suggests that pirtobrutinib might be an effective treatment for chronic lymphocytic leukemia?
Research has shown that pirtobrutinib holds promise for treating chronic lymphocytic leukemia (CLL). In one study, 93.4% of patients did not experience cancer progression over 24 months. Pirtobrutinib targets the BTK protein, which aids cancer cell growth, making it effective even when other similar treatments fail. It has also demonstrated positive results in patients who previously tried other BTK inhibitors. Overall, studies have found pirtobrutinib effective and well-tolerated for CLL. Participants in this trial will receive pirtobrutinib as part of the treatment regimen.678910
Who Is on the Research Team?
Jennifer A Woyach, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for older adults diagnosed with chronic lymphocytic leukemia (CLL). Participants should be considered elderly and able to undergo study procedures. People with other types of leukemia or serious health issues that could interfere with the trial may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pirtobrutinib orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits within 7-30 days and then every 6 months for up to 8 years.
What Are the Treatments Tested in This Trial?
Interventions
- Pirtobrutinib
Trial Overview
The study is testing pirtobrutinib, a new BTK inhibitor pill, in elderly patients with CLL to see how well it works. The trial includes regular checkups, blood tests, bone marrow samples, scans, and questionnaires to monitor progress.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive pirtobrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, blood sample collection, and bone marrow biopsy and aspiration throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Woyach
Lead Sponsor
Citations
BRUIN CLL-313: Randomized Phase III Trial of ...
the 24-month PFS rate was 93.4% despite an effective crossover rate of 52.9%. in 3.6% versus 31.1% of patients;
FDA grants traditional approval to pirtobrutinib for chronic ...
Median PFS was 11.2 months. At an updated analysis with a median follow-up time of 19.8 months, the HR for overall survival (OS) was 1.09 (95% ...
Pirtobrutinib (Jaypirca)
Pirtobrutinib is used for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL).
Pirtobrutinib
Pirtobrutinib, sold under the brand name Jaypirca, is an anti-cancer medication that is used to treat mantle cell lymphoma. It inhibits B cell lymphocyte ...
5.
medchemexpress.com
medchemexpress.com/btk-inhibitor-16.html?srsltid=AU7gw4X5qhfhjfz4Sek7D6nwEb9V75kiEo44xzSrLL0WKNHCiL2XFccfBTK Inhibitor - Pirtobrutinib (LOXO-305)
Pirtobrutinib causes regression of BTK-dependent lymphoma tumors in mouse xenograft models. Pirtobrutinib is also more than 300-fold selective for BTK versus ...
6.
onclive.com
onclive.com/view/pirtobrutinib-continues-to-show-safety-activity-in-covalent-btk-inhibitor-pretreated-r-r-mclPirtobrutinib Continues to Show Safety, Activity in Covalent ...
The median progression-free survival (PFS) was 5.6 months (95% CI, 5.3-9.2) at a median follow-up of 15.9 months, and the median overall ...
7.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/6535/504584/Patient-Reported-Outcomes-PROs-Among-Patients-withPatient-Reported Outcomes (PROs) Among Patients with ...
Overall, consistent with the favorable safety profile of pirtobrutinib, HRQoL and symptoms were stable or improved for over 70% of patients
8.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(26)02073-2/fulltextCLL-916: Real-World Outcomes of Pirtobrutinib Versus ...
At 365 days, death occurred in 92 patients on pirtobrutinib and 78 patients with survival of 79.66% and 83.68%, respectively
Pirtobrutinib Yields Improved Survival Outcomes in ...
Safety and Next Steps Treatment-emergent AEs of any grade occurred in 93.1% of patients receiving pirtobrutinib and in 98.2% of those receiving ...
10.
targetedonc.com
targetedonc.com/view/updated-bruin-data-shows-high-response-rates-with-pirtobrutinib-in-cll-sllUpdated BRUIN Data Shows High Response Rates With ...
At this time, treatment with pirtobrutinib led to an ORR of 81.6% (95% CI, 76.5%-85.9%) in the 282 patients included in the population.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.