Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05677919
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood, tissue, stool, and saliva samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI scan
  • Pirtobrutinib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Venetoclax — DRUG
    Given PO
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Biopsy — PROCEDURE
    Undergo tissue biopsy

Study Details

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.

Key Dates

Start date
Jan 31, 2023
Status verified
Feb 2026
Primary completion
Nov 11, 2026
Completion
Sep 3, 2030

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pirtobrutinib and venetoclax)
    Patients receive pirtobrutinib and venetoclax PO on study. Patients also undergo CT, MRI, and PET scans during screening and on study. Patients also undergo bone marrow aspiration and bone marrow biopsy, and collection of blood, tissue, stool, and saliva samples on study.

Primary Outcome Measure

Undetected minimal residual disease (uMRD) [ Time Frame: After cycle 15 (1 cycle = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic in Rochester· Rochester, MN

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