Pirtobrutinib for CLL
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL.
Objective:
To test pirtobrutinib as a first-line treatment for CLL or SLL.
Eligibility:
People aged 18 years and older with untreated CLL or SLL.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue.
Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles.
Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months.
Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits.
A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug.
Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research.
Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....
Who Is on the Research Team?
Laura S Samples, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pirtobrutinib 200 mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits or phone calls every 6 to 12 months
Optional Research Activities
Participants may opt to have cancer and immune cells collected from their blood for research purposes
What Are the Treatments Tested in This Trial?
Interventions
- Pirtobrutinib
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Pirtobrutinib will be administered orally at a dose of 200 mg once daily in 28-day cycles, and participants will continue treatment until disease progression, unacceptable toxicity, or meeting other discontinuation criteria
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
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.