50 Participants NeededMy employer runs this trial

Pirtobrutinib for Leukemia

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Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

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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

My bilirubin levels are within the allowed range for my liver condition.
Creatinine clearance ≥ 30 mL/min using Cockcroft-Gault formula
aPTT/PT/INR not greater than 2.0 × ULN
See 13 more

Exclusion Criteria

Other clinically significant uncontrolled conditions posing risk to participation
I have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
I do not have another active cancer, or it is in remission and I expect to live over 2 years.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 12 cycles (approximately 12 months)
Monthly visits for CT, blood sample collection, and bone marrow biopsy

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.

Up to 8 years
Initial follow-up within 7-30 days, then every 6 months

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

Group I: Treatment (pirtobrutinib)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jennifer Woyach

Lead Sponsor

Trials
4
Recruited
100+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41363773/

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 ...

BTK 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 ...

Pirtobrutinib 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 ...

Patient-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

CLL-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 ...

Updated 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.