Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
study ends around
Principal Investigator
by Catherine C. Coombs (uci)Joseph M. Tuscano (ucdavis)

Description

Summary

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Official Title

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Details

Keywords

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoma, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Venetoclax, Obinutuzumab, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, early V-O

Eligibility

Locations

Lead Scientists at University of California Health

  • Catherine C. Coombs (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 34 research publications
  • Joseph M. Tuscano (ucdavis)
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 116 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04269902
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 247 study participants
Last Updated