Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Henan Cancer Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must meet all of the following criteria:
1. Age 18 years or older.
2. Histologically and immunophenotypically confirmed mantle cell lymphoma.
3. At least one measurable lesion.
4. Received at least one prior systemic treatment regimen that included a BTK-targeted therapy, including a covalent BTK inhibitor, non-covalent BTK inhibitor, or BTK degrader, and had stable disease, disease progression, or intolerance during or after the most recent BTK-targeted therapy.
5. Eastern Cooperative Oncology Group performance status of 0 to 2.
6. Adequate hepatic, renal, and bone marrow function, defined as all of the following:
\* Aspartate aminotransferase and alanine aminotransferase ≤3 × upper limit of normal;
* Total bilirubin ≤1.5 × upper limit of normal;
* Creatinine clearance ≥30 mL/min;
* Absolute neutrophil count ≥0.5 × 10\^9/L;
* Platelet count ≥30 × 10\^9/L. Supportive treatment is permitted.
7. Participants of reproductive potential must agree to use effective contraception during study treatment and for 3 months after the last dose of study treatment.
8. Willing and able to comply with study procedures and follow-up assessments.
9. Able to understand and voluntarily sign the informed consent form before screening.
You may not be if
1\. Known hypersensitivity to pirtobrutinib, lisaftoclax, or any component or excipient of either study drug.
2\. Concurrent participation in another clinical study. 3. Prior treatment with any BCL-2 inhibitor. 4. Active central nervous system involvement, including parenchymal or leptomeningeal disease.
5\. Clinically significant uncontrolled cardiac or cardiovascular disease, or a history of myocardial infarction within 6 months before the planned initiation of pirtobrutinib.
6\. Uncontrolled active severe systemic bacterial, viral, fungal, or parasitic infection.
7\. Current treatment with strong CYP3A4 inhibitors or inducers and/or strong P-glycoprotein inhibitors.
8\. Positive human immunodeficiency virus test. 9. Active hepatitis B or hepatitis C infection, except:
* Participants with detectable hepatitis B virus DNA whose disease is controlled may be enrolled at the investigator's discretion, provided that concurrent antiviral therapy is administered;
* Participants with a history of hepatitis C virus infection who have completed antiviral treatment and have a viral load below the lower limit of quantification may be enrolled.
10\. Pregnant or breastfeeding women. 11. Unable to complete protocol-required study visits or procedures, including follow-up visits, or unable to comply with study requirements.
12\. Any other clinically significant current or prior medical condition that, in the investigator's judgment, may pose a risk to participant safety or interfere with study assessments, procedures, or completion.
Clareo Health | Lisaftoclax Plus Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma After BTK-Targeted Therapy
