Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKerry Rogers

About this trial

This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Giving venetoclax in combination with SOC zanubrutinib may be safe and tolerable and may reduce the number of cancer cells that remain in the body in patients with CLL or SLL that have not previously received treatment or at least two years have passed since completing initial treatment.

Eligibility criteria

Qualifiers

Diagnosis of CLL/SLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

Age ≥ 18 years

Indications for treatment as defined by the iwCLL 2018 Guidelines

Received prior treatment or not depending on cohort

Disqualifiers

Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment

Frontline arm only: Patients with deletion 17p and/or TP53 mutation

Active Richter's transformation

Prior zanubrutinib exposure

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Venetoclax
  • Zanubrutinib

Treatment groups

155 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kerry Rogers

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

AbbVie

Collaborator