Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia
NCT05677919 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-02-12
Summary
This phase II trial studies how well pirtobrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This study also seeks to adopt a blood test which shows a small number of cancer cells in the body after cancer treatment called minimal residual disease as a guide to determine length of treatment. Drugs used in chemotherapy, such as pirtobrutinib and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Identifying minimal residual disease results after combination chemotherapy may help guide future treatment decisions for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Conditions
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood, tissue, stool, and saliva samples
- PROCEDURE
-
Bone Marrow Aspiration
Undergo bone marrow aspiration
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI scan
- DRUG
-
Pirtobrutinib
Given PO
- PROCEDURE
-
Positron Emission Tomography
Undergo PET scan
- DRUG
-
Given PO
- PROCEDURE
-
Echocardiography
Undergo ECHO
- PROCEDURE
-
Multigated Acquisition Scan
Undergo MUGA
- PROCEDURE
-
Biopsy
Undergo tissue biopsy
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Yucai Wang, MD, PhD · Mayo Clinic in Rochester
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2026-11-11
- Completion
- 2030-09-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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