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NCT04269902 · ClinicalTrials.gov record · last posted 2026-08-27

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

StatusRecruiting
PhasePhase 3
Started2021-03-02
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 708 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 708 times since 2020-02-13; most recent amendment 2026-07-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2020-12-29
Status change Not Yet Recruiting→Recruitingv5
Trial Details
NCT Number NCT04269902
Lead Sponsor National Cancer Institute (NCI)
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 247 participants
Start Date 2021-03-02
Primary Completion 2028-10-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-27