Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About 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....
Eligibility criteria
Qualifiers
Stated willingness to comply with all study procedures
Age >=18 years
Confirmed diagnosis of CLL or SLL according to International Workshop on CLL (iwCLL) guidelines
Coexpression of CD5, CD19, CD20, and CD23 expression and light-chain restriction; CD23 dim or negative expression is acceptable as long as other parameters are consistent with a diagnosis of CLL.
Disqualifiers
Diagnosis of Richter Transformation
Documented CNS involvement
Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment. WOCBP must have a negative serum pregnancy test.
Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.
Trial design
Treatments tested in this trial
- Pirtobrutinib
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov